Back to resultsPlacebo-controlled, Study of Concurrent Chemoradiation Therapy With Pembrolizumab Followed by Pembrolizumab and Olaparib in Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC) (MK 7339-013/KEYLYNK-013)
Primary Purpose
Small Cell Lung Cancer
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pembrolizumab 200 mg
Pembrolizumab 400 mg
Pembrolizumab placebo (saline)
Pembrolizumab placebo (saline)
Olaparib 300 mg BID
Olaparib matching placebo
Etoposide 100 mg/m^2
Platinum, investigator's choice
Standard Thoracic Radiotherapy
Prophylactic Cranial Irradiation (PCI)
Sponsored by
About this trial
This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1), Pembrolizumab, Olaparib
Eligibility Criteria
Inclusion Criteria:
Has pathologically (histologically or cytologically) confirmed Small Cell Lung Cancer (SCLC).
Note: Note: Participants with histology showing a mixed tumor with small cell and non-small cell elements are not eligible.
- Has Limited-Stage SCLC (Stage I-III, by AJCC 8th Edition Cancer Staging), and can be safely treated with definitive radiation doses.
- Has no evidence of metastatic disease by whole body positron emission tomography /computed tomography (PET/CT scan), CT or magnetic resonance imaging (MRI) scans
- Has at least 1 lesion that meets the criteria for being measurable, as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
- Has not received prior treatment (chemotherapy or radiotherapy or surgery resection) of LS-SCLC.
- Is not expected to require tumor resection during the course of the study.
- Must submit a pre-treatment tumor tissue sample (formalin-fixed, paraffin embedded blocks are preferred to slides) including cytologic sample, if tissue sample unavailable.
- Has Eastern Cooperative Oncology Group (ECOG) Performance score 0 or 1 assessed within 7 days prior to the first administration of study intervention.
- Has a life expectancy of at least 6 months.
- Has adequate organ function.
- Male and female participants who are not pregnant and of childbearing potential must follow contraceptive guidance during the treatment period and for the time needed to eliminate each study intervention.
- Male and female participants who are at least 18 years of age at the time of signing the information consent.
- Male participants must refrain from donating sperm during the treatment period and for the time needed to eliminate each study intervention.
Abstains from breastfeeding during the study intervention period and for at least the following period after the last study intervention:
- Pembrolizumab: 120 days
- Olaparib: 7 days
Exclusion Criteria:
- Has history, current diagnosis, or features suggestive of myelodysplastic syndrome/ acute myeloid leukemia (MDS/AML).
- Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PDL1), or anti- programmed cell death ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor
- Has received prior therapy with olaparib or with any other polyadenosine 5'diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor.
- Had major surgery <4 weeks prior to the first dose of study intervention (except for placement of vascular access).
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention.
- Has a known additional malignancy that is progressing or has required active treatment within the past 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
- Has severe hypersensitivity (≥ Grade 3) to study intervention and/or any of its excipients.
- Has an active autoimmune disease that has required systemic treatment in past 2 years
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that requires steroids
- Has an active infection requiring systemic therapy.
- Has a known history of human immunodeficiency virus (HIV) infection or Hepatitis B or known active Hepatitis C virus infection.
Sites / Locations
- Ironwood Cancer & Research Centers ( Site 0007)Recruiting
- Loma Linda University Cancer Center ( Site 0011)Recruiting
- Georgetown University ( Site 0017)
- Moffitt Cancer Center ( Site 0137)Recruiting
- Fort Wayne Medical Oncology and Hematology ( Site 0034)Recruiting
- University of Kentucky Chandler Medical Center ( Site 0138)Recruiting
- Overton Brooks VAMC ( Site 0041)
- Harry & Jeanette Weinberg Cancer Institute ( Site 0045)Recruiting
- VA Ann Arbor Healthcare System ( Site 0050)Recruiting
- St. Vincent Healthcare Frontier Cancer Center ( Site 0056)
- Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0061)Recruiting
- Memorial Sloan Kettering - Basking Ridge ( Site 0133)Recruiting
- John Theurer Cancer Center ( Site 0064)
- Memorial Sloan Kettering - Monmouth ( Site 0135)Recruiting
- Memorial Sloan Kettering - Bergen ( Site 0130)Recruiting
- Rutgers Cancer Institute of New Jersey ( Site 0123)Recruiting
- Memorial Sloan Kettering- Commack ( Site 0132)Recruiting
- Memorial Sloan Kettering - Westchester-Thoracic Oncology ( Site 0134)Recruiting
- Memorial Sloan Kettering Cancer Center ( Site 0069)Recruiting
- Memorial Sloan Kettering - Nassau ( Site 0131)Recruiting
- Cleveland Clinic ( Site 0139)Recruiting
- Penn State Hershey Cancer Institute ( Site 0081)
- Saint Francis Cancer Center ( Site 0087)
- The University of Tennessee Medical Center ( Site 0116)Recruiting
- Texas Oncology - Dallas (Presbyterian)_McIntyre ( Site 0098)
- Texas Oncology - Dallas (Sammons) ( Site 0093)Recruiting
- MD Anderson Cancer Center ( Site 0100)Recruiting
- Providence Regional Cancer Partnership ( Site 0106)Recruiting
- Medical Oncology Associates, PS ( Site 0142)Recruiting
- Multicare Institute For Research And Innovation ( Site 0108)
- Virginia Mason Memorial- North Star Lodge Cancer Center ( Site 0112)
- Campbelltown Hospital ( Site 3002)Recruiting
- Nepean Hospital ( Site 3001)Recruiting
- Calvary Mater Newcastle ( Site 3000)Recruiting
- Gold Coast University Hospital ( Site 3003)Recruiting
- Frankston Hospital-Oncology and Haematology ( Site 3007)Recruiting
- Austin Health-Austin Hospital ( Site 3006)Recruiting
- Western Health-Sunshine Hospital ( Site 3004)Recruiting
- Saint-Luc UCL ( Site 1005)Recruiting
- Grand Hopital de Charleroi ( Site 1003)Recruiting
- C.I.U. Hopital Ambroise Pare ( Site 1001)Recruiting
- CHU UCL Namur Site de Godinne ( Site 1004)Recruiting
- UZ Leuven ( Site 1002)Recruiting
- AZ Delta ( Site 1000)Recruiting
- MHAT "Uni Hospital" OOD ( Site 2507)Recruiting
- Cross Cancer Institute ( Site 0206)Recruiting
- Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0212)Recruiting
- CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0202)Recruiting
- McGill University Health Centre ( Site 0210)Recruiting
- CIUSSS de la Mauricie et du Centre du Quebec ( Site 0200)Recruiting
- Beijing Cancer Hospital ( Site 3127)Recruiting
- Peking Union Medical College Hospital ( Site 3102)
- Cancer Hospital Chinese Academy of Medical Sciences ( Site 3104)
- Beijing Cancer hospital-Oncology Radiotherapy Department ( Site 3140)
- Chongqing Cancer Hospital ( Site 3135)
- Daping Hospital,Third Military Medical University ( Site 3136)
- Fujian Provincial Cancer Hospital ( Site 3126)Recruiting
- The First Affiliated Hospital of Xiamen University ( Site 3121)Recruiting
- Peking University Shenzhen Hospital ( Site 3118)Recruiting
- Cancer Hospital Chinese Academy Of Medical Sciences. Shenzhen Center ( Site 3113)
- Henan Cancer Hospital ( Site 3105)Recruiting
- Wuhan Union Hospital ( Site 3123)
- Tongji Medical College Huazhong University of Science and Technology ( Site 3138)
- Hubei Cancer Hospital ( Site 3120)Recruiting
- Hunan Cancer Hospital ( Site 3133)
- Xiangya Hospital of Central South University ( Site 3137)
- Second Xiangya Hospital of Central-South University ( Site 3128)
- Jiangsu Cancer Hospital ( Site 3139)
- The Second Affiliated Hospital of Nanchang University ( Site 3106)Recruiting
- The First Hospital of Jilin University ( Site 3132)
- Shandong Province Cancer Hospital ( Site 3100)Recruiting
- Shanghai Chest Hospital ( Site 3107)
- Shanghai Pulmonary Hospital ( Site 3101)Recruiting
- West China Hospital of Sichuan University ( Site 3114)
- Tianjin Medical University Cancer Institute & Hospital ( Site 3103)
- Hangzhou Cancer Hospital ( Site 3129)Recruiting
- The 1st Affil Hosp of College of Medicine, Zhejiang Univ ( Site 3131)Recruiting
- Zhejiang Cancer Hospital.... ( Site 3108)Recruiting
- SA Pohja-Eesti Regionaalhaigla ( Site 2201)
- SA Tartu Ulikooli Kliinikum ( Site 2200)Recruiting
- C.H. de Saint Quentin ( Site 1111)Recruiting
- CHU de Bordeaux Hop St ANDRE ( Site 1115)Recruiting
- Clinique Clairval ( Site 1108)Recruiting
- Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 1105)Recruiting
- CHU Grenoble -Hop Michallon ( Site 1102)Recruiting
- Institut De Cancerologie De L Ouest ( Site 1110)Recruiting
- Institut de Cancerologie de l Ouest Site Paul Papin ( Site 1103)Recruiting
- Hopital Avicenne ( Site 1106)
- H.I.A. Sainte-Anne ( Site 1101)Recruiting
- Henry Dunant Hospital ( Site 1205)Recruiting
- Sotiria Regional Chest Diseases Hospital of Athens ( Site 1200)Recruiting
- University General Hospital of Herakleion ( Site 1202)Recruiting
- Anti-Cancer Hospital of Thessaloniki Theagenio ( Site 1204)
- University General Hospital of Larisa ( Site 1201)Recruiting
- Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1306)Recruiting
- Petz Aladar Megyei Oktato Korhaz ( Site 1312)Recruiting
- Törökbálinti Tüdőgyógyintézet ( Site 1304)Recruiting
- Orszagos Koranyi Pulmonologiai Intezet ( Site 1301)Recruiting
- Orszagos Onkologiai Intezet ( Site 1310)Recruiting
- Uzsoki Utcai Korhaz ( Site 1303)
- Rambam Health Care Campus-Oncology Division ( Site 1401)Recruiting
- Chaim Sheba Medical Center ( Site 1400)Recruiting
- A O U Policlinico di Modena ( Site 1503)Recruiting
- Azienda Ospedaliero Universitaria Careggi ( Site 1509)Recruiting
- Azienda Ospedaliera Spedali Civili di Brescia ( Site 1512)Recruiting
- IRCCS Ospedale San Raffaele ( Site 1500)Recruiting
- Istituto Nazionale dei Tumori ( Site 1504)Recruiting
- Istituto Europeo di Oncologia ( Site 1501)Recruiting
- IRCCS Istituto Oncologico Veneto ( Site 1506)Recruiting
- Policlinico Universitario Agostino Gemelli ( Site 1505)Recruiting
- Aichi Cancer Center Hospital ( Site 4010)Recruiting
- Kobe Minimally Invasive Cancer Center ( Site 4003)Recruiting
- Takarazuka City Hospital ( Site 4013)Recruiting
- Kanagawa Cancer Center ( Site 4001)Recruiting
- Kansai Medical University Hospital ( Site 4009)Recruiting
- Osaka Medical and Pharmaceutical University Hospital ( Site 4007)Recruiting
- Shizuoka Cancer Center ( Site 4014)Recruiting
- National Hospital Organization Kyushu Cancer Center ( Site 4000)Recruiting
- Niigata Cancer Center Hospital ( Site 4004)Recruiting
- Okayama University Hospital ( Site 4012)Recruiting
- Osaka International Cancer Institute ( Site 4005)Recruiting
- National Cancer Center Hospital ( Site 4015)Recruiting
- Juntendo University Hospital ( Site 4008)Recruiting
- Tokyo Metropolitan Komagome Hospital ( Site 4011)Recruiting
- The Cancer Institute Hospital of JFCR ( Site 4006)Recruiting
- Showa University Hospital ( Site 4002)Recruiting
- National Cancer Center ( Site 3306)Recruiting
- Seoul National University Bundang Hospital ( Site 3301)Recruiting
- The Catholic University of Korea St. Vincent s Hospital ( Site 3303)Recruiting
- Inje University Haeundae Paik Hospital ( Site 3307)Recruiting
- Asan Medical Center ( Site 3308)Recruiting
- Keimyung University Dongsan Hospital ( Site 3302)
- Severance Hospital Yonsei University Health System ( Site 3304)Recruiting
- Samsung Medical Center ( Site 3300)Recruiting
- Nacionalinis Vezio Institutas ( Site 2300)Recruiting
- LSMUL Kauno Klinikos ( Site 2301)Recruiting
- Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0401)Recruiting
- Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0404)Recruiting
- Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 1705)Recruiting
- Centro Hospitalar Lisboa Norte E.P.E. - Hospital Pulido Valente ( Site 1704)Recruiting
- Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E. ( Site 1701)Recruiting
- Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 2803)Recruiting
- Amethyst Radiotherapy Center-Oncologie Medicala ( Site 2805)Recruiting
- Spitalul Municipal Ploiesti ( Site 2801)Recruiting
- Cabinet Medical Oncomed ( Site 2802)Recruiting
- S.C.Focus Lab Plus S.R.L ( Site 2804)Recruiting
- Moscow Regional Oncological Dispensary-Oncology (thoracic surgery) Department №1 ( Site 1815)
- Main Military Clinical Hospital n.a. N.N.Burdenko ( Site 1812)
- MROI n.a. P.A. Herzen - branch of FSBI NMICR of MoH of Russia ( Site 1800)
- Nizhniy Novgorod Region Oncology Dispensary ( Site 1811)
- Omsk Clinical Oncology Dispensary ( Site 1806)
- Sverdlovsk Regional Oncology Hospital ( Site 1807)
- Republican Clinical Oncology Dispensary-Chemotherapy #1 ( Site 1814)
- Institute for Oncology and Radiology of Serbia ( Site 2995)Recruiting
- Institut za plucne bolesti Vojvodine Sremska Kamenica ( Site 2991)Recruiting
- Steve Biko Academic Hospital ( Site 5000)Recruiting
- Groote Schuur Hospital ( Site 5002)Recruiting
- Hospital Universitario Central de Asturias ( Site 1900)Recruiting
- Hospital Duran i Reynals ( Site 1903)Recruiting
- Hospital Universitari Vall d Hebron ( Site 1904)Recruiting
- Hospital Universitario 12 de Octubre ( Site 1902)Recruiting
- Hospital Regional Universitario de Malaga ( Site 1905)Recruiting
- Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 1907)Recruiting
- Ankara Bilkent Sehir Hastanesi ( Site 2007)Recruiting
- Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2009)Recruiting
- Medipol Universite Hastanesi ( Site 2005)Recruiting
- Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2003)Recruiting
- Ege Universitesi Tip Fakultesi Hastanesi ( Site 2001)Recruiting
- Medical center Medikal Plaza of Ecodnipro LLC ( Site 2107)
- Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 2110)
- Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 2104)
- Clinic of National Cancer Institute ( Site 2101)Recruiting
- Medical Center Verum ( Site 2106)
- LISOD. Hospital ( Site 2111)
- Kyiv City Clinical Oncology Center ( Site 2100)
- Royal Infirmary Aberdeen ( Site 2403)Recruiting
- Ninewells Hospital and Medical School ( Site 2401)Recruiting
- Taunton and Somerset Hospital ( Site 2404)Recruiting
- Barts Health NHS Trust ( Site 2409)Recruiting
- Guy s & St Thomas NHS Foundation Trust ( Site 2408)Recruiting
- The Christie NHS Foundation Trust ( Site 2405)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Group A - Pembrolizumab 200 mg
Group B - Pembrolizumab 200 mg plus Olaparib 300 mg BID
Group C (Pembrolizumab and Olaparib Matching Placebos)
Arm Description
Participants will receive 4 cycles of standard-of-care chemotherapy (etoposide/platinum) plus pembrolizumab 200 mg every 3 weeks (Q3W) concurrently with standard thoracic radiotherapy, followed by 9 cycles of pembrolizumab 400 mg every 6 weeks (Q6W) plus olaparib matching placebo twice daily (BID) for 12 months or until specific discontinuation criteria are met.
Participants will receive 4 cycles of standard-of-care chemotherapy (etoposide/platinum) plus pembrolizumab 200 mg Q3W concurrently with standard thoracic radiotherapy, followed by 9 cycles of pembrolizumab 400 mg Q6W plus olaparib 300 mg BID for 12 months or until specific discontinuation criteria are met.
Participants will receive 4 cycles of standard-of-care chemotherapy (etoposide/platinum) plus pembrolizumab placebo (saline) Q3W concurrently with standard thoracic radiotherapy, followed by 9 cycles of pembrolizumab placebo (saline) Q6W plus olaparib matching placebo for 12 months or until specific discontinuation criteria are met.
Outcomes
Primary Outcome Measures
Progression-free Survival Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1); the time from randomization to progression or death due to any cause, whichever occurs first
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) is the time from randomization to progression or death due to any cause, whichever occurs first.
Overall Survival: the time from randomization to death due to any cause
Overall Survival (OS) is the time from randomization to death due to any cause.
Secondary Outcome Measures
Number of Participants Experiencing an Adverse Events (AEs)
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Number of Participants Discontinuing Study Treatment Due to Adverse Events (AEs)
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Objective Response (OR): Complete Response (CR) or Partial Response (PR)
Percentage of participants in the analysis population who have a best overall response of either confirmed CR or a PR per RECIST 1.1.
Duration of Response (DOR): the time from the earliest date of first documented evidence of confirmed CR or PR until the earliest date of disease progression or death from any cause, whichever comes first
DOR is the time from the earliest date of first documented evidence of confirmed CR or PR until the earliest date of disease progression or death from any cause, whichever comes first.
Change from Baseline at Cycle 1 in European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status / Quality of Life (Items 29 & 30) Scale Score
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "How would you rate your overall health during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 scores will be presented.
Change from Baseline at Cycle 1 in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score
The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQC30 questionnaire. Participant responses to the question "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 cough (Item 1) score will be presented.
Change from Baseline at Cycle 1 in EORTC QLQ-LC13 Chest Pain (Item 10) Scale Score
The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQC30 questionnaire. Participant responses to the question "How was your chest pain?" are scored on a 4 point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 chest pain (Item 10) score will be presented.
Change from Baseline at Cycle 1 in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 dyspnea (Item 8) score will be presented.
Change from Baseline at Cycle 1 in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Score
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) score will be presented.
Time to True Deterioration (TTD) in EORTC QLQ-C30 Global Health Status / Quality of Life (Items 29 & 30) Scale Score
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "How would you rate your overall health during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in EORTC QLQ-C30 Items 29 and 30 scale scores.
Time to True Deterioration (TTD) in Cough (LC13/Item 1) Scale Score
The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQC30 questionnaire. Participant responses to the question "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in cough EORTC QLQLC13 cough (Item 1) scale score.
Time to True Deterioration (TTD) in Chest Pain (LC13/Item 10) Scale Score
The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQC30 questionnaire. Participant responses to the question "How was your chest pain?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in EORTC QLQ-LC13 chest pain (Item 10) scale score.
Time to True Deterioration (TTD) in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in EORTC QLQ-C30 dyspnea (Item 8) scale score.
Time to True Deterioration (TTD) in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Score
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in EORTC QLQ-C30 physical functioning (Items 1 to 5) scale scores.
Objective Response (OR, according to RECIST 1.1 by BICR) assessed by programmed cell death ligand 1 (PD-L1) expression levels
Percentage of participants in the analysis population who have a best overall response of either confirmed CR or a PR per RECIST 1.1, analyzed by programmed cell death ligand 1 (PD-L1) expression levels.
Duration of Response (DOR, according to RECIST 1.1 by BICR) assessed by programmed cell death ligand 1 (PD-L1) expression levels
DOR is the time from the earliest date of first documented evidence of confirmed CR or PR until the earliest date of disease progression or death from any cause, whichever comes first, analyzed by programmed cell death ligand 1 (PD-L1) expression levels.
Progression-free Survival (PFS, according to RECIST 1.1 by BICR) assessed by programmed cell death ligand 1 (PD-L1) expression levels
Progression-free Survival Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1); the time from randomization to progression or death due to any cause, whichever occurs first, analyzed by programmed cell death ligand 1 (PD-L1) expression levels.
Overall Survival (OS) assessed by programmed cell death ligand 1 (PD-L1) expression levels
Overall Survival: the time from randomization to death due to any cause, analyzed by programmed cell death ligand 1 (PD-L1) expression levels.
Full Information
NCT ID
NCT04624204
First Posted
November 5, 2020
Last Updated
October 18, 2023
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT04624204
Brief Title
Placebo-controlled, Study of Concurrent Chemoradiation Therapy With Pembrolizumab Followed by Pembrolizumab and Olaparib in Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC) (MK 7339-013/KEYLYNK-013)
Official Title
A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Pembrolizumab (MK-3475) in Combination With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib (MK-7339), Compared to Concurrent Chemoradiation Therapy Alone in Participants With Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 8, 2020 (Actual)
Primary Completion Date
October 28, 2027 (Anticipated)
Study Completion Date
October 28, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to compare overall survival (OS) and progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR).
Hypothesis (H1): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib is superior to concurrent chemoradiation therapy alone with respect to PFS per RECIST 1.1 by BICR.
Hypothesis (H2): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab is superior to concurrent chemoradiation therapy alone with respect to PFS per RECIST 1.1 by BICR.
Hypothesis (H3): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib is superior to concurrent chemoradiation therapy alone with respect to OS.
Hypothesis (H4): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab is superior to concurrent chemoradiation therapy alone with respect to OS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer
Keywords
Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1), Pembrolizumab, Olaparib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
672 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A - Pembrolizumab 200 mg
Arm Type
Experimental
Arm Description
Participants will receive 4 cycles of standard-of-care chemotherapy (etoposide/platinum) plus pembrolizumab 200 mg every 3 weeks (Q3W) concurrently with standard thoracic radiotherapy, followed by 9 cycles of pembrolizumab 400 mg every 6 weeks (Q6W) plus olaparib matching placebo twice daily (BID) for 12 months or until specific discontinuation criteria are met.
Arm Title
Group B - Pembrolizumab 200 mg plus Olaparib 300 mg BID
Arm Type
Experimental
Arm Description
Participants will receive 4 cycles of standard-of-care chemotherapy (etoposide/platinum) plus pembrolizumab 200 mg Q3W concurrently with standard thoracic radiotherapy, followed by 9 cycles of pembrolizumab 400 mg Q6W plus olaparib 300 mg BID for 12 months or until specific discontinuation criteria are met.
Arm Title
Group C (Pembrolizumab and Olaparib Matching Placebos)
Arm Type
Placebo Comparator
Arm Description
Participants will receive 4 cycles of standard-of-care chemotherapy (etoposide/platinum) plus pembrolizumab placebo (saline) Q3W concurrently with standard thoracic radiotherapy, followed by 9 cycles of pembrolizumab placebo (saline) Q6W plus olaparib matching placebo for 12 months or until specific discontinuation criteria are met.
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab 200 mg
Other Intervention Name(s)
MK-3475, KEYTRUDA®
Intervention Description
Pembrolizumab 200 mg Q3W
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab 400 mg
Other Intervention Name(s)
MK-3475, KEYTRUDA®
Intervention Description
Pembrolizumab 400 mg Q6W
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab placebo (saline)
Intervention Description
Pembrolizumab placebo (saline) Q3W
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab placebo (saline)
Intervention Description
Pembrolizumab placebo (saline) Q6W
Intervention Type
Drug
Intervention Name(s)
Olaparib 300 mg BID
Other Intervention Name(s)
MK-7339, LYNPARZA®
Intervention Description
Olaparib 300 mg twice daily (BID)
Intervention Type
Drug
Intervention Name(s)
Olaparib matching placebo
Intervention Description
Olaparib matching placebo BID
Intervention Type
Drug
Intervention Name(s)
Etoposide 100 mg/m^2
Intervention Description
Etoposide 100 mg/m^2 intravenous (IV) Q3W, Day 1-3
Intervention Type
Drug
Intervention Name(s)
Platinum, investigator's choice
Intervention Description
Carboplatin titrated to an area under the plasma drug concentration time curve (AUC) of 5 mg/mL/min IV Q3W OR Cisplatin 75 mg/m^2 IV Q3W on Day 1 of each cycle
Intervention Type
Radiation
Intervention Name(s)
Standard Thoracic Radiotherapy
Intervention Description
Standard Thoracic Radiotherapy
Intervention Type
Radiation
Intervention Name(s)
Prophylactic Cranial Irradiation (PCI)
Intervention Description
PCI will be strongly recommended for participants who achieve CR or PR after completion of chemoradiation treatment.
Primary Outcome Measure Information:
Title
Progression-free Survival Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1); the time from randomization to progression or death due to any cause, whichever occurs first
Description
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) is the time from randomization to progression or death due to any cause, whichever occurs first.
Time Frame
Up to approximately 59 months
Title
Overall Survival: the time from randomization to death due to any cause
Description
Overall Survival (OS) is the time from randomization to death due to any cause.
Time Frame
Up to approximately 82 months
Secondary Outcome Measure Information:
Title
Number of Participants Experiencing an Adverse Events (AEs)
Description
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Time Frame
Up to approximately 82 months
Title
Number of Participants Discontinuing Study Treatment Due to Adverse Events (AEs)
Description
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Time Frame
Up to approximately 82 months
Title
Objective Response (OR): Complete Response (CR) or Partial Response (PR)
Description
Percentage of participants in the analysis population who have a best overall response of either confirmed CR or a PR per RECIST 1.1.
Time Frame
Up to approximately 82 months
Title
Duration of Response (DOR): the time from the earliest date of first documented evidence of confirmed CR or PR until the earliest date of disease progression or death from any cause, whichever comes first
Description
DOR is the time from the earliest date of first documented evidence of confirmed CR or PR until the earliest date of disease progression or death from any cause, whichever comes first.
Time Frame
Up to approximately 82 months
Title
Change from Baseline at Cycle 1 in European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status / Quality of Life (Items 29 & 30) Scale Score
Description
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "How would you rate your overall health during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 scores will be presented.
Time Frame
Baseline and 82 months post randomization
Title
Change from Baseline at Cycle 1 in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score
Description
The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQC30 questionnaire. Participant responses to the question "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 cough (Item 1) score will be presented.
Time Frame
Baseline and 82 months post randomization
Title
Change from Baseline at Cycle 1 in EORTC QLQ-LC13 Chest Pain (Item 10) Scale Score
Description
The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQC30 questionnaire. Participant responses to the question "How was your chest pain?" are scored on a 4 point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 chest pain (Item 10) score will be presented.
Time Frame
Baseline and 82 months post randomization
Title
Change from Baseline at Cycle 1 in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score
Description
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 dyspnea (Item 8) score will be presented.
Time Frame
Baseline and 82 months post randomization
Title
Change from Baseline at Cycle 1 in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Score
Description
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) score will be presented.
Time Frame
Baseline and 82 months post randomization
Title
Time to True Deterioration (TTD) in EORTC QLQ-C30 Global Health Status / Quality of Life (Items 29 & 30) Scale Score
Description
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "How would you rate your overall health during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in EORTC QLQ-C30 Items 29 and 30 scale scores.
Time Frame
Up to approximately 82 months post randomization
Title
Time to True Deterioration (TTD) in Cough (LC13/Item 1) Scale Score
Description
The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQC30 questionnaire. Participant responses to the question "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in cough EORTC QLQLC13 cough (Item 1) scale score.
Time Frame
Up to approximately 82 months post randomization
Title
Time to True Deterioration (TTD) in Chest Pain (LC13/Item 10) Scale Score
Description
The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQC30 questionnaire. Participant responses to the question "How was your chest pain?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in EORTC QLQ-LC13 chest pain (Item 10) scale score.
Time Frame
Up to approximately 82 months post randomization
Title
Time to True Deterioration (TTD) in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score
Description
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in EORTC QLQ-C30 dyspnea (Item 8) scale score.
Time Frame
Up to approximately 82 months post randomization
Title
Time to True Deterioration (TTD) in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Score
Description
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in EORTC QLQ-C30 physical functioning (Items 1 to 5) scale scores.
Time Frame
Up to approximately 82 months post randomization
Title
Objective Response (OR, according to RECIST 1.1 by BICR) assessed by programmed cell death ligand 1 (PD-L1) expression levels
Description
Percentage of participants in the analysis population who have a best overall response of either confirmed CR or a PR per RECIST 1.1, analyzed by programmed cell death ligand 1 (PD-L1) expression levels.
Time Frame
Up to approximately 82 months
Title
Duration of Response (DOR, according to RECIST 1.1 by BICR) assessed by programmed cell death ligand 1 (PD-L1) expression levels
Description
DOR is the time from the earliest date of first documented evidence of confirmed CR or PR until the earliest date of disease progression or death from any cause, whichever comes first, analyzed by programmed cell death ligand 1 (PD-L1) expression levels.
Time Frame
Up to approximately 82 months
Title
Progression-free Survival (PFS, according to RECIST 1.1 by BICR) assessed by programmed cell death ligand 1 (PD-L1) expression levels
Description
Progression-free Survival Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1); the time from randomization to progression or death due to any cause, whichever occurs first, analyzed by programmed cell death ligand 1 (PD-L1) expression levels.
Time Frame
Up to approximately 59 months
Title
Overall Survival (OS) assessed by programmed cell death ligand 1 (PD-L1) expression levels
Description
Overall Survival: the time from randomization to death due to any cause, analyzed by programmed cell death ligand 1 (PD-L1) expression levels.
Time Frame
Up to approximately 82 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Has pathologically (histologically or cytologically) confirmed Small Cell Lung Cancer (SCLC).
Note: Note: Participants with histology showing a mixed tumor with small cell and non-small cell elements are not eligible.
Has Limited-Stage SCLC (Stage I-III, by AJCC 8th Edition Cancer Staging), and can be safely treated with definitive radiation doses.
Has no evidence of metastatic disease by whole body positron emission tomography /computed tomography (PET/CT scan), CT or magnetic resonance imaging (MRI) scans
Has at least 1 lesion that meets the criteria for being measurable, as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
Has not received prior treatment (chemotherapy or radiotherapy or surgery resection) of LS-SCLC.
Is not expected to require tumor resection during the course of the study.
Must submit a pre-treatment tumor tissue sample (formalin-fixed, paraffin embedded blocks are preferred to slides) including cytologic sample, if tissue sample unavailable.
Has Eastern Cooperative Oncology Group (ECOG) Performance score 0 or 1 assessed within 7 days prior to the first administration of study intervention.
Has a life expectancy of at least 6 months.
Has adequate organ function.
Male and female participants who are not pregnant and of childbearing potential must follow contraceptive guidance during the treatment period and for the time needed to eliminate each study intervention.
Male and female participants who are at least 18 years of age at the time of signing the information consent.
Male participants must refrain from donating sperm during the treatment period and for the time needed to eliminate each study intervention.
Abstains from breastfeeding during the study intervention period and for at least the following period after the last study intervention:
Pembrolizumab: 120 days
Olaparib: 7 days
Exclusion Criteria:
Has history, current diagnosis, or features suggestive of myelodysplastic syndrome/ acute myeloid leukemia (MDS/AML).
Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PDL1), or anti- programmed cell death ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor
Has received prior therapy with olaparib or with any other polyadenosine 5'diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor.
Had major surgery <4 weeks prior to the first dose of study intervention (except for placement of vascular access).
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention.
Has a known additional malignancy that is progressing or has required active treatment within the past 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
Has severe hypersensitivity (≥ Grade 3) to study intervention and/or any of its excipients.
Has an active autoimmune disease that has required systemic treatment in past 2 years
Has a history of (non-infectious) pneumonitis/interstitial lung disease that requires steroids
Has an active infection requiring systemic therapy.
Has a known history of human immunodeficiency virus (HIV) infection or Hepatitis B or known active Hepatitis C virus infection.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Toll Free Number
Phone
1-888-577-8839
Email
Trialsites@merck.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director, MD
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Ironwood Cancer & Research Centers ( Site 0007)
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
480-398-7674
Facility Name
Loma Linda University Cancer Center ( Site 0011)
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
909-558-4050
Facility Name
Georgetown University ( Site 0017)
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Completed
Facility Name
Moffitt Cancer Center ( Site 0137)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
813-745-4673
Facility Name
Fort Wayne Medical Oncology and Hematology ( Site 0034)
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
260-436-0800
Facility Name
University of Kentucky Chandler Medical Center ( Site 0138)
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
859-323-5000
Facility Name
Overton Brooks VAMC ( Site 0041)
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Individual Site Status
Completed
Facility Name
Harry & Jeanette Weinberg Cancer Institute ( Site 0045)
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
443-777-7364
Facility Name
VA Ann Arbor Healthcare System ( Site 0050)
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
734-769-7100
Facility Name
St. Vincent Healthcare Frontier Cancer Center ( Site 0056)
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Individual Site Status
Completed
Facility Name
Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0061)
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
308-398-5450
Facility Name
Memorial Sloan Kettering - Basking Ridge ( Site 0133)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
646-608-3793
Facility Name
John Theurer Cancer Center ( Site 0064)
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Completed
Facility Name
Memorial Sloan Kettering - Monmouth ( Site 0135)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
848-225-6000
Facility Name
Memorial Sloan Kettering - Bergen ( Site 0130)
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
646-608-3793
Facility Name
Rutgers Cancer Institute of New Jersey ( Site 0123)
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
732-235-2465
Facility Name
Memorial Sloan Kettering- Commack ( Site 0132)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
646-608-3793
Facility Name
Memorial Sloan Kettering - Westchester-Thoracic Oncology ( Site 0134)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
646-608-3793
Facility Name
Memorial Sloan Kettering Cancer Center ( Site 0069)
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
646-608-3793
Facility Name
Memorial Sloan Kettering - Nassau ( Site 0131)
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
646-608-3793
Facility Name
Cleveland Clinic ( Site 0139)
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
216-636-6888
Facility Name
Penn State Hershey Cancer Institute ( Site 0081)
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Completed
Facility Name
Saint Francis Cancer Center ( Site 0087)
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Individual Site Status
Completed
Facility Name
The University of Tennessee Medical Center ( Site 0116)
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
865-305-4893
Facility Name
Texas Oncology - Dallas (Presbyterian)_McIntyre ( Site 0098)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Completed
Facility Name
Texas Oncology - Dallas (Sammons) ( Site 0093)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
214-826-9797
Facility Name
MD Anderson Cancer Center ( Site 0100)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
844-215-4940
Facility Name
Providence Regional Cancer Partnership ( Site 0106)
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
425-297-5577
Facility Name
Medical Oncology Associates, PS ( Site 0142)
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
509-462-2273
Facility Name
Multicare Institute For Research And Innovation ( Site 0108)
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Individual Site Status
Completed
Facility Name
Virginia Mason Memorial- North Star Lodge Cancer Center ( Site 0112)
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States
Individual Site Status
Completed
Facility Name
Campbelltown Hospital ( Site 3002)
City
Campbelltown
State/Province
New South Wales
ZIP/Postal Code
2560
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+61246344300
Facility Name
Nepean Hospital ( Site 3001)
City
Kingswood
State/Province
New South Wales
ZIP/Postal Code
2747
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+61247343500
Facility Name
Calvary Mater Newcastle ( Site 3000)
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+61240143282
Facility Name
Gold Coast University Hospital ( Site 3003)
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+61756870000
Facility Name
Frankston Hospital-Oncology and Haematology ( Site 3007)
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+61397847175
Facility Name
Austin Health-Austin Hospital ( Site 3006)
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+61394969863
Facility Name
Western Health-Sunshine Hospital ( Site 3004)
City
St Albans
State/Province
Victoria
ZIP/Postal Code
3021
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+61385959167
Facility Name
Saint-Luc UCL ( Site 1005)
City
Brussels
State/Province
Bruxelles-Capitale, Region De
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3227642833
Facility Name
Grand Hopital de Charleroi ( Site 1003)
City
Charleroi
State/Province
Hainaut
ZIP/Postal Code
6000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3271104766
Facility Name
C.I.U. Hopital Ambroise Pare ( Site 1001)
City
Mons
State/Province
Hainaut
ZIP/Postal Code
7000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3265413746
Facility Name
CHU UCL Namur Site de Godinne ( Site 1004)
City
Yvoir
State/Province
Namur
ZIP/Postal Code
5530
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3281422111
Facility Name
UZ Leuven ( Site 1002)
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3216346802
Facility Name
AZ Delta ( Site 1000)
City
Roeselare
State/Province
West-Vlaanderen
ZIP/Postal Code
8800
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3251237216
Facility Name
MHAT "Uni Hospital" OOD ( Site 2507)
City
Panagyurishte
State/Province
Pazardzhik
ZIP/Postal Code
4500
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
00359885797096
Facility Name
Cross Cancer Institute ( Site 0206)
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
7804328762
Facility Name
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0212)
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V5C2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
905-387-9495
Facility Name
CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0202)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
5143453511 x6734
Facility Name
McGill University Health Centre ( Site 0210)
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
5149341934 ext38930
Facility Name
CIUSSS de la Mauricie et du Centre du Quebec ( Site 0200)
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G8Z 3R9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
8196973333
Facility Name
Beijing Cancer Hospital ( Site 3127)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13701224460
Facility Name
Peking Union Medical College Hospital ( Site 3102)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100006
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences ( Site 3104)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Beijing Cancer hospital-Oncology Radiotherapy Department ( Site 3140)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Chongqing Cancer Hospital ( Site 3135)
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400030
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Daping Hospital,Third Military Medical University ( Site 3136)
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Fujian Provincial Cancer Hospital ( Site 3126)
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+8613906900190
Facility Name
The First Affiliated Hospital of Xiamen University ( Site 3121)
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
8613806000926
Facility Name
Peking University Shenzhen Hospital ( Site 3118)
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518036
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+8613823394076
Facility Name
Cancer Hospital Chinese Academy Of Medical Sciences. Shenzhen Center ( Site 3113)
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518116
Country
China
Individual Site Status
Completed
Facility Name
Henan Cancer Hospital ( Site 3105)
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
865512922342
Facility Name
Wuhan Union Hospital ( Site 3123)
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Tongji Medical College Huazhong University of Science and Technology ( Site 3138)
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Completed
Facility Name
Hubei Cancer Hospital ( Site 3120)
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
027-87670138
Facility Name
Hunan Cancer Hospital ( Site 3133)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410006
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Xiangya Hospital of Central South University ( Site 3137)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Second Xiangya Hospital of Central-South University ( Site 3128)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Jiangsu Cancer Hospital ( Site 3139)
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Completed
Facility Name
The Second Affiliated Hospital of Nanchang University ( Site 3106)
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
8613767120022
Facility Name
The First Hospital of Jilin University ( Site 3132)
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Shandong Province Cancer Hospital ( Site 3100)
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250117
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0531-67627107
Facility Name
Shanghai Chest Hospital ( Site 3107)
City
Shangai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Shanghai Pulmonary Hospital ( Site 3101)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200443
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
02165115006
Facility Name
West China Hospital of Sichuan University ( Site 3114)
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
510115
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Tianjin Medical University Cancer Institute & Hospital ( Site 3103)
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Hangzhou Cancer Hospital ( Site 3129)
City
Hanghzou
State/Province
Zhejiang
ZIP/Postal Code
310002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
18857110928
Facility Name
The 1st Affil Hosp of College of Medicine, Zhejiang Univ ( Site 3131)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+8613957162839
Facility Name
Zhejiang Cancer Hospital.... ( Site 3108)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0571-88122261
Facility Name
SA Pohja-Eesti Regionaalhaigla ( Site 2201)
City
Tallinn
State/Province
Harjumaa
ZIP/Postal Code
13419
Country
Estonia
Individual Site Status
Completed
Facility Name
SA Tartu Ulikooli Kliinikum ( Site 2200)
City
Tartu
State/Province
Tartumaa
ZIP/Postal Code
51014
Country
Estonia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3735513443
Facility Name
C.H. de Saint Quentin ( Site 1111)
City
Saint quentin
State/Province
Aisne
ZIP/Postal Code
02100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33360125235
Facility Name
CHU de Bordeaux Hop St ANDRE ( Site 1115)
City
Bordeaux
State/Province
Aquitaine
ZIP/Postal Code
33075
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
33556795808
Facility Name
Clinique Clairval ( Site 1108)
City
Marseille
State/Province
Bouches-du-Rhone
ZIP/Postal Code
13009
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0033496196230
Facility Name
Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 1105)
City
Paris
State/Province
Ile-de-France
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33158413091
Facility Name
CHU Grenoble -Hop Michallon ( Site 1102)
City
Grenoble
State/Province
Isere
ZIP/Postal Code
38043
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33476767575
Facility Name
Institut De Cancerologie De L Ouest ( Site 1110)
City
Saint Herblain
State/Province
Loire-Atlantique
ZIP/Postal Code
44805
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33240679821
Facility Name
Institut de Cancerologie de l Ouest Site Paul Papin ( Site 1103)
City
Angers
State/Province
Maine-et-Loire
ZIP/Postal Code
49000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33241352739
Facility Name
Hopital Avicenne ( Site 1106)
City
Bobigny
State/Province
Seine-Saint-Denis
ZIP/Postal Code
93000
Country
France
Individual Site Status
Completed
Facility Name
H.I.A. Sainte-Anne ( Site 1101)
City
Toulon
State/Province
Var
ZIP/Postal Code
83800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33483162916
Facility Name
Henry Dunant Hospital ( Site 1205)
City
Athens
State/Province
Attiki
ZIP/Postal Code
115 26
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+306983519989
Facility Name
Sotiria Regional Chest Diseases Hospital of Athens ( Site 1200)
City
Athens
State/Province
Attiki
ZIP/Postal Code
115 27
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+302107700220
Facility Name
University General Hospital of Herakleion ( Site 1202)
City
Heraklion
State/Province
Irakleio
ZIP/Postal Code
711 10
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
302810392750
Facility Name
Anti-Cancer Hospital of Thessaloniki Theagenio ( Site 1204)
City
Thessaloniki
State/Province
Kentriki Makedonia
ZIP/Postal Code
54007
Country
Greece
Individual Site Status
Completed
Facility Name
University General Hospital of Larisa ( Site 1201)
City
Larissa
State/Province
Thessalia
ZIP/Postal Code
411 10
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+302413502027
Facility Name
Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1306)
City
Kecskemét
State/Province
Bacs-Kiskun
ZIP/Postal Code
6000
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
003676519853
Facility Name
Petz Aladar Megyei Oktato Korhaz ( Site 1312)
City
Gyor
State/Province
Gyor-Moson-Sopron
ZIP/Postal Code
9024
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3696507900
Facility Name
Törökbálinti Tüdőgyógyintézet ( Site 1304)
City
Torokbalint
State/Province
Pest
ZIP/Postal Code
2045
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3623511570
Facility Name
Orszagos Koranyi Pulmonologiai Intezet ( Site 1301)
City
Budapest
ZIP/Postal Code
1121
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0036205651900
Facility Name
Orszagos Onkologiai Intezet ( Site 1310)
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3612248600
Facility Name
Uzsoki Utcai Korhaz ( Site 1303)
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Individual Site Status
Completed
Facility Name
Rambam Health Care Campus-Oncology Division ( Site 1401)
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+97247776700
Facility Name
Chaim Sheba Medical Center ( Site 1400)
City
Ramat Gan
ZIP/Postal Code
5262000
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+97235307096
Facility Name
A O U Policlinico di Modena ( Site 1503)
City
Modena
State/Province
Emilia-Romagna
ZIP/Postal Code
41100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+39 3381446063
Facility Name
Azienda Ospedaliero Universitaria Careggi ( Site 1509)
City
Florence
State/Province
Firenze
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+393209225506
Facility Name
Azienda Ospedaliera Spedali Civili di Brescia ( Site 1512)
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390303995271
Facility Name
IRCCS Ospedale San Raffaele ( Site 1500)
City
Milano
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
390226436627
Facility Name
Istituto Nazionale dei Tumori ( Site 1504)
City
Milano
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390223903813
Facility Name
Istituto Europeo di Oncologia ( Site 1501)
City
Milano
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390257489440
Facility Name
IRCCS Istituto Oncologico Veneto ( Site 1506)
City
Padova
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+39 3923633461
Facility Name
Policlinico Universitario Agostino Gemelli ( Site 1505)
City
Roma
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390630155202
Facility Name
Aichi Cancer Center Hospital ( Site 4010)
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-52-762-6111
Facility Name
Kobe Minimally Invasive Cancer Center ( Site 4003)
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0046
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-78-304-4100
Facility Name
Takarazuka City Hospital ( Site 4013)
City
Takarazuka
State/Province
Hyogo
ZIP/Postal Code
665-0827
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-797-87-1161
Facility Name
Kanagawa Cancer Center ( Site 4001)
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-45-520-2222
Facility Name
Kansai Medical University Hospital ( Site 4009)
City
Hirakata
State/Province
Osaka
ZIP/Postal Code
573-1191
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-72-804-0101
Facility Name
Osaka Medical and Pharmaceutical University Hospital ( Site 4007)
City
Takatsuki
State/Province
Osaka
ZIP/Postal Code
5698686
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-72-683-1221
Facility Name
Shizuoka Cancer Center ( Site 4014)
City
Nagaizumi
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81559895222
Facility Name
National Hospital Organization Kyushu Cancer Center ( Site 4000)
City
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-92-541-3231
Facility Name
Niigata Cancer Center Hospital ( Site 4004)
City
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-25-266-5111
Facility Name
Okayama University Hospital ( Site 4012)
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-86-223-7151
Facility Name
Osaka International Cancer Institute ( Site 4005)
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-6-6945-1181
Facility Name
National Cancer Center Hospital ( Site 4015)
City
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-3-3542-2511
Facility Name
Juntendo University Hospital ( Site 4008)
City
Tokyo
ZIP/Postal Code
113-0033
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-3-3813-3111
Facility Name
Tokyo Metropolitan Komagome Hospital ( Site 4011)
City
Tokyo
ZIP/Postal Code
113-8677
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-3-3823-2101
Facility Name
The Cancer Institute Hospital of JFCR ( Site 4006)
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-3-3520-0111
Facility Name
Showa University Hospital ( Site 4002)
City
Tokyo
ZIP/Postal Code
142-8666
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-3-3784-8000
Facility Name
National Cancer Center ( Site 3306)
City
Goyang-si
State/Province
Kyonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82319201694
Facility Name
Seoul National University Bundang Hospital ( Site 3301)
City
Seongnam-si
State/Province
Kyonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82317877003
Facility Name
The Catholic University of Korea St. Vincent s Hospital ( Site 3303)
City
Suwon-si
State/Province
Kyonggi-do
ZIP/Postal Code
16247
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82312498153
Facility Name
Inje University Haeundae Paik Hospital ( Site 3307)
City
Busan
State/Province
Pusan-Kwangyokshi
ZIP/Postal Code
48108
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82517970008
Facility Name
Asan Medical Center ( Site 3308)
City
Songpagu
State/Province
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82230105935
Facility Name
Keimyung University Dongsan Hospital ( Site 3302)
City
Daegu
State/Province
Taegu-Kwangyokshi
ZIP/Postal Code
42601
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
Severance Hospital Yonsei University Health System ( Site 3304)
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82222288126
Facility Name
Samsung Medical Center ( Site 3300)
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82234101795
Facility Name
Nacionalinis Vezio Institutas ( Site 2300)
City
Vilnius
State/Province
Vilniaus Miestas
ZIP/Postal Code
08660
Country
Lithuania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+37052786748
Facility Name
LSMUL Kauno Klinikos ( Site 2301)
City
Kaunas
ZIP/Postal Code
50161
Country
Lithuania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+37037326457
Facility Name
Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0401)
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
523315145351
Facility Name
Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0404)
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+528183338111
Facility Name
Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 1705)
City
Lisboa
ZIP/Postal Code
1099-023
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+351217229800
Facility Name
Centro Hospitalar Lisboa Norte E.P.E. - Hospital Pulido Valente ( Site 1704)
City
Lisboa
ZIP/Postal Code
1769-001
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+351217548000
Facility Name
Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E. ( Site 1701)
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+351225084000
Facility Name
Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 2803)
City
Cluj-Napoca
State/Province
Cluj
ZIP/Postal Code
400015
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4026459831
Facility Name
Amethyst Radiotherapy Center-Oncologie Medicala ( Site 2805)
City
Florești
State/Province
Cluj
ZIP/Postal Code
407280
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+40742206212
Facility Name
Spitalul Municipal Ploiesti ( Site 2801)
City
Ploiesti
State/Province
Prahova
ZIP/Postal Code
100337
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+40740062630
Facility Name
Cabinet Medical Oncomed ( Site 2802)
City
Timisoara
State/Province
Timis
ZIP/Postal Code
300239
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+40256495403
Facility Name
S.C.Focus Lab Plus S.R.L ( Site 2804)
City
Bucuresti
ZIP/Postal Code
022548
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+40721298677
Facility Name
Moscow Regional Oncological Dispensary-Oncology (thoracic surgery) Department №1 ( Site 1815)
City
Balashikha
State/Province
Moskovskaya Oblast
ZIP/Postal Code
143900
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Main Military Clinical Hospital n.a. N.N.Burdenko ( Site 1812)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
105094
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
MROI n.a. P.A. Herzen - branch of FSBI NMICR of MoH of Russia ( Site 1800)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
125284
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Nizhniy Novgorod Region Oncology Dispensary ( Site 1811)
City
Nizhny Novgorod
State/Province
Nizhegorodskaya Oblast
ZIP/Postal Code
603081
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Omsk Clinical Oncology Dispensary ( Site 1806)
City
Omsk
State/Province
Omskaya Oblast
ZIP/Postal Code
644013
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Sverdlovsk Regional Oncology Hospital ( Site 1807)
City
Ekaterinburg
State/Province
Sverdlovskaya Oblast
ZIP/Postal Code
620036
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Republican Clinical Oncology Dispensary-Chemotherapy #1 ( Site 1814)
City
Kazan
State/Province
Tatarstan, Respublika
ZIP/Postal Code
420029
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Institute for Oncology and Radiology of Serbia ( Site 2995)
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
381641379926
Facility Name
Institut za plucne bolesti Vojvodine Sremska Kamenica ( Site 2991)
City
Sremska Kamenica
State/Province
Sremski Okrug
ZIP/Postal Code
21204
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
381642636187
Facility Name
Steve Biko Academic Hospital ( Site 5000)
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0002
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+27123466701
Facility Name
Groote Schuur Hospital ( Site 5002)
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7925
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+27214044266
Facility Name
Hospital Universitario Central de Asturias ( Site 1900)
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
34985106100x39705
Facility Name
Hospital Duran i Reynals ( Site 1903)
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34932607744
Facility Name
Hospital Universitari Vall d Hebron ( Site 1904)
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34934894158
Facility Name
Hospital Universitario 12 de Octubre ( Site 1902)
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34914692313
Facility Name
Hospital Regional Universitario de Malaga ( Site 1905)
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34951291425
Facility Name
Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 1907)
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34955926578
Facility Name
Ankara Bilkent Sehir Hastanesi ( Site 2007)
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905555306271
Facility Name
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2009)
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905324167355
Facility Name
Medipol Universite Hastanesi ( Site 2005)
City
Istanbul
ZIP/Postal Code
34214
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905325280486
Facility Name
Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2003)
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905063509061
Facility Name
Ege Universitesi Tip Fakultesi Hastanesi ( Site 2001)
City
Izmir
ZIP/Postal Code
35040
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905322202675
Facility Name
Medical center Medikal Plaza of Ecodnipro LLC ( Site 2107)
City
Dnipro
State/Province
Dnipropetrovska Oblast
ZIP/Postal Code
49055
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 2110)
City
Kharkiv
State/Province
Kharkivska Oblast
ZIP/Postal Code
61024
Country
Ukraine
Individual Site Status
Completed
Facility Name
Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 2104)
City
Kapitanivka Village
State/Province
Kyivska Oblast
ZIP/Postal Code
08111
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Clinic of National Cancer Institute ( Site 2101)
City
Kyiv
State/Province
Kyivska Oblast
ZIP/Postal Code
03022
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+380442579315
Facility Name
Medical Center Verum ( Site 2106)
City
Kyiv
State/Province
Kyivska Oblast
ZIP/Postal Code
03039
Country
Ukraine
Individual Site Status
Completed
Facility Name
LISOD. Hospital ( Site 2111)
City
Pliuty
State/Province
Kyiv
ZIP/Postal Code
08720
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Kyiv City Clinical Oncology Center ( Site 2100)
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Royal Infirmary Aberdeen ( Site 2403)
City
Aberdeen
State/Province
Aberdeen City
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
03454566000
Facility Name
Ninewells Hospital and Medical School ( Site 2401)
City
Dundee
State/Province
Dundee City
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
01382 435543
Facility Name
Taunton and Somerset Hospital ( Site 2404)
City
Taunton
State/Province
England
ZIP/Postal Code
TA1 5DA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
01823333444
Facility Name
Barts Health NHS Trust ( Site 2409)
City
London
State/Province
London, City Of
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+447779785642
Facility Name
Guy s & St Thomas NHS Foundation Trust ( Site 2408)
City
London
State/Province
London, City Of
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+442071887188
Facility Name
The Christie NHS Foundation Trust ( Site 2405)
City
Manchester
ZIP/Postal Code
M20 4GJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0161 446 3745
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
35613997
Citation
Rimner A, Lai WV, Califano R, Jabbour SK, Rudin CM, Faivre-Finn C, Cho BC, Kato T, Yu J, Chafin W, Yu L, Zhao B, Byers L. Rationale and Design of the Phase 3 KEYLYNK-013 Study of Pembrolizumab With Concurrent Chemoradiotherapy Followed by Pembrolizumab With or Without Olaparib for Limited-Stage Small-Cell Lung Cancer. Clin Lung Cancer. 2022 Jul;23(5):e325-e329. doi: 10.1016/j.cllc.2022.04.005. Epub 2022 Apr 29.
Results Reference
derived
Links:
URL
https://www.merckclinicaltrials.com/
Description
Merck Clinical Trials Information
Learn more about this trial
Placebo-controlled, Study of Concurrent Chemoradiation Therapy With Pembrolizumab Followed by Pembrolizumab and Olaparib in Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC) (MK 7339-013/KEYLYNK-013)
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