Back to resultsStudy of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionable Genomic Alterations (TROPION-Lung08)
Primary Purpose
Metastatic Non Small Cell Lung Cancer
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Datopotamab Deruxtecan
Pembrolizumab
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Non Small Cell Lung Cancer focused on measuring Metastatic Non Small Cell Lung Cancer, Advanced Non Small Cell Lung Cancer, Datopotamab Deruxtecan (Dato-DXd), Pembrolizumab
Eligibility Criteria
Inclusion Criteria:
Participants eligible for inclusion in the study must meet all inclusion criteria within 28 days of randomization into the study.
- Sign and date the Tissue Screening and Main Informed Consent Forms, prior to the start of any study-specific qualification procedures.
- Adults ≥18 years or the minimum legal adult age (whichever is greater) at the time of informed consent.
Histologically documented NSCLC that meets all of the following criteria:
- Stage IIIB or IIIC disease and not candidates for surgical resection or definitive chemoradiation, or Stage IV NSCLC disease at the time of randomization (based on the American Joint Committee on Cancer, Eighth Edition).
- Documented negative test results for epidermal growth factor receptor (EGFR), lymphoma kinase (ALK), and proto-oncogene1 (ROS1) actionable genomic alterations based on analysis of tumor tissue.
- No known actionable genomic alterations in neurotrophic tyrosine receptor kinase (NTRK), proto-oncogene B-raf (BRAF), rearranged during transfection (RET), mesenchymal-epithelial transition factor (MET), or other actionable driver kinases with locally approved therapies.
- Has provided a formalin-fixed tumor tissue sample for the measurement of trophoblast cell surface protein 2 (TROP2) protein expression and for the assessment of other exploratory biomarkers.
- Tumor has high programmed death receptor-1 (PD-L1) expression (TPS ≥50%) as determined by PD-L1 immunohistochemistry (IHC) 22C3 pharmDx assay by central testing (minimum of 6 slides).
- Has an adequate treatment washout period before Cycle 1 Day 1.
- Measurable disease based on local imaging assessment using RECIST Version 1.1.
- Has left ventricular ejection fraction (LVEF) ≥50% by either an echocardiogram (ECHO) or multigated acquisition scan (MUGA) within 28 days before randomization.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at screening.
- Has a life expectancy of at least 3 months.
- Adequate bone marrow function within 7 days before randomization.
Exclusion Criteria:
- Has received prior systemic treatment for advanced or metastatic NSCLC.
Has received prior treatment with any of the following, including in the adjuvant/neoadjuvant setting:
- Any agent, including an antibody-drug conjugate, containing a chemotherapeutic agent targeting topoisomerase I.
- TROP2-targeted therapy.
- Any anti-programmed death receptor-1 (PD-1), anti-PD-L1, or anti-PD-ligand 2 (L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX40, CD137).
- Any other immune checkpoint inhibitors. Participants who received adjuvant or neoadjuvant therapy OTHER than those listed above, are eligible if the adjuvant/neoadjuvant therapy was completed at least 6 months prior to the diagnosis of advanced/metastatic disease.
- Has spinal cord compression or active and untreated central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable.
- Has received prior radiotherapy ≤4 weeks of start of study intervention or more than 30 Gy (unit of ionizing radiation dose in the International System of Units) to the lung within 6 months of Cycle 1 Day 1.
History of another primary malignancy (beyond NSCLC) except for:
- Malignancy treated with curative intent and with no known active disease ≥3 years before the first dose of study treatment and of low potential risk for recurrence.
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
- Adequately treated carcinoma in situ without evidence of disease.
- Participants with a history of prostate cancer (tumor/node/metastasis stage) of Stage ≤T2cN0M0 without biochemical recurrence or progression and who in the opinion of the Investigator are not deemed to require active intervention.
- Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
- Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder, or any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement or prior complete pneumonectomy.
Uncontrolled or significant cardiovascular disease, including:
- Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) interval >470 msec regardless of sex (based on the average of the 12-lead electrocardiogram determination at screening).
- Myocardial infarction within 6 months prior to randomization.
- Uncontrolled angina pectoris within 6 months prior to randomization.
- LVEF <50% by ECHO or MUGA scan within 28 days before randomization.
- New York Heart Association Class 2 to 4 congestive heart failure (CHF) at screening.
- Uncontrolled hypertension (resting systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg) within 28 days before randomization.
Participants with a history of Class 2 to 4 CHF prior to screening, must have returned to Class 1 CHF and have LVEF ≥50% (by either an ECHO or MUGA scan within 28 days before randomization) in order to be eligible.
- Clinically significant corneal disease.
- Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. For any participant receiving an approved severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccine, please follow the vaccine label and/or local guidance.
- Active, known, or suspected autoimmune disease (has an active autoimmune disease that has required systemic treatment in the past 2 years).
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosage >10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy ≤7 days prior to the first dose of study drug.
- Has known human immunodeficiency virus (HIV) infection that is not well controlled.
- Has an active hepatitis or uncontrolled hepatitis B or active hepatitis C infection; is positive for hepatitis B or C virus based on the evaluation of results of tests for hepatitis B (hepatitis b surface antigen, anti-HBs, anti-HBc, or hepatitis B virus [HBV] DNA) or hepatitis C virus (HCV RNA) infection.
- Has an uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
- Had an allogeneic tissue/solid organ transplant.
- Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients (including but not limited to polysorbate 80) of Dato-DXd or pembrolizumab.
Sites / Locations
- Ironwood Cancer and Research CenterRecruiting
- UCLA HemOnc - Clinical Research UnitRecruiting
- Compassionate Cancer Care Medical GroupRecruiting
- UCSF Helen Diller Family Comprehensive Cancer CenterRecruiting
- Ridley-Tree Cancer CenterRecruiting
- PIH Health Whittier HospitalRecruiting
- The Oncology Institute of Hope and InnovationRecruiting
- Uch-Mhs D/B/A Memorial Health SystemRecruiting
- Johns Hopkins UniversityRecruiting
- American Oncology Partners of MarylandRecruiting
- Dana-Farber Cancer InstituteRecruiting
- Dartmouth Hitchcock Medical CenterRecruiting
- Astera Cancer CareRecruiting
- Regional Cancer Care Associates LLCRecruiting
- Cooperman Barnabas Medical CenterRecruiting
- The Valley HospitalRecruiting
- Montefiore Medical CenterRecruiting
- Arizona Oncology NAHOARecruiting
- Cancer Care Center of BrevardRecruiting
- Maryland Oncology HematologyRecruiting
- Southern Cancer CenterRecruiting
- Texas Oncology - Northeast TexasRecruiting
- Texas Oncology Gulf CoastRecruiting
- Texas Oncology McAllenRecruiting
- University of Texas Health Science Center San AntonioRecruiting
- Utah Cancer SpecialistsRecruiting
- Providence Regional Cancer SystemRecruiting
- Medical College of WisconsinRecruiting
- Fundacion CENIT para la investigación en NeurocienciasRecruiting
- Centro de Investigación Pergamino S. A.Recruiting
- Instituto de Oncología de RosarioRecruiting
- Sanatorio ParqueRecruiting
- Sanatorio Británico de RosarioRecruiting
- Clinica Viedma SARecruiting
- Austin HospitalRecruiting
- Peninsula and South Eastern Haematology and Oncology GroupRecruiting
- Chris Obrien LifehouseRecruiting
- The Queen Elizabeth HospitalRecruiting
- Onze-Lieve-Vrouwziekenhuis Olvz - Campus AalstRecruiting
- Grand Hopital de Charleroi - Hopital Saint JosephRecruiting
- Az Maria Middelares - Campus Maria MiddelaresRecruiting
- AZ NikolaasRecruiting
- Instituto de Pesquisas em Saúde - IPSRecruiting
- Oncosite - Centro de Pesquisa Clinica OncologiaRecruiting
- UPCO - Unidade de Pesquisas Clínicas em Oncologia - Clinica LacksRecruiting
- Santa Casa de Misericordia de Porto AlegreRecruiting
- Instituto Nacional de Câncer - INCARecruiting
- Centro de Estudos e Pesquisa de Hematologia e Oncologia - CEPHORecruiting
- Instituto de Ensino e Pesquisas Sao LucasRecruiting
- Santa Cabrini HospitalRecruiting
- Centro de Estudios Clínicos SAGARecruiting
- OncovidaRecruiting
- Fundación Arturo Pérez LópezRecruiting
- Centro de Investigaciones Clinicas Vina Del MarRecruiting
- Guangxi Medical University Affiliated Tumor HospitalRecruiting
- Henan Cancer HospitalRecruiting
- Jilin Cancer HospitalRecruiting
- Peking University Peoples HospitalRecruiting
- Peking University Cancer HospitalRecruiting
- Hunan Cancer HospitalRecruiting
- Affiliated Cancer Hospital and Institute of Guangzhou Medical UniversityRecruiting
- Haikou People's HospitalRecruiting
- The First Affiliated Hospital of College of Medicine Zhejiang UniversityRecruiting
- Zhejiang Cancer Hospital
- Harbin Medical University Cancer HospitalRecruiting
- Inner Mongolia Medical University- the Affiliated HospitalRecruiting
- Jiamusi Tumor and Tuberculosis HospitalRecruiting
- Yunnan Cancer HospitalRecruiting
- Linyi Cancer HospitalRecruiting
- The First Affiliated Hospital of Nanchang UniversityRecruiting
- Jiangsu Province HospitalRecruiting
- The Second People's Hospital of NeijiangRecruiting
- Fudan University Shanghai Cancer CenterRecruiting
- Shanghai Pulmonary HospitalRecruiting
- Liaoning Cancer Hospital& InstituteRecruiting
- The First Hospital of China Medical UniversityRecruiting
- Union Hospital Affiliated With Tongji Medical College Huazhong University of Science and TechnologyRecruiting
- Hubei Cancer HospitalRecruiting
- The First Affiliate Hospitalof Xi'An Jiaotong UniversityRecruiting
- The First Affiliated Hospital Xiamen UniversityRecruiting
- Xinjiang Tumor HospitalRecruiting
- Bordeaux University Hospital - Hopital Saint AndreRecruiting
- Institut BergonieRecruiting
- Centre Hospitalier Universitaire de LilleRecruiting
- Centre Leon BerardRecruiting
- APHM - Hopital NordRecruiting
- Centre Hospitalier Universitaire de MontpellierRecruiting
- Hopital prive du ConfluentRecruiting
- CHU de NantesRecruiting
- AP-HP - Hopital TenonRecruiting
- CHU de Poitier Pole Regional de CancerologieRecruiting
- Hopital FOCHRecruiting
- Evangelische Lungenklinik BerlinRecruiting
- Klinikum Esslingen GmbHRecruiting
- LungenClinic GrosshansdorfRecruiting
- Klinikum der Universitaet MuenchenRecruiting
- Metropolitan HospitalRecruiting
- Sotiria General Hosptial of Chest DiseasesRecruiting
- University Hospital of Ioannina UhiRecruiting
- Metropolitan HospitalRecruiting
- Bioclinic ThessalonikiRecruiting
- Prince of Wales Hospital / The Chinese University of Hong Kong 99999Recruiting
- Queen Elizabeth HospitalRecruiting
- Queen Mary HospitalRecruiting
- Semmelweis University Department of PulmonologyRecruiting
- Veszprem Megyei Tudogyogyintezet FarkasgyepuRecruiting
- Bkmk HospitalRecruiting
- Fejer Megyei Szent Gyorgy Egyetemi Oktato KorhazRecruiting
- Pulmonology Hospital TorokbalintRecruiting
- IRCCS Istituto Oncologico Giovanni Paolo IIRecruiting
- UOC OncologiaRecruiting
- IRCCS Ospedale San RaffaeleRecruiting
- Irccs Istituto Europeo Di OncologiaRecruiting
- Azienda Ospedaliera dei ColliRecruiting
- A.O. Perugia Santa Maria della MisericordiaRecruiting
- Policlinico Tor VergataRecruiting
- Ifo Regina ElenaRecruiting
- Asst Sette Laghi Ospedale di Circolo e Fondazione MacchiRecruiting
- Aomori Prefectural Central HospitalRecruiting
- National Cancer Center Hospital EastRecruiting
- NHO Shikoku Cancer CenterRecruiting
- National Hospital Organization Kyushu Cancer CenterRecruiting
- Kyushu University HospitalRecruiting
- Kurume University HospitalRecruiting
- Kanazawa University HospitalRecruiting
- Kanagawa Cancer CenterRecruiting
- Saiseikai Kumamoto HospitalRecruiting
- Matsusaka Municipal HospitalRecruiting
- Sendai Kousei HospitalRecruiting
- Niigata Cancer Center HospitalRecruiting
- Kansai Medical University HospitalRecruiting
- Osaka International Cancer InstituteRecruiting
- NHO Kinki-Chuo Chest Medical CenterRecruiting
- Saitama Cancer CenterRecruiting
- Dokkyo Medical University HospitalRecruiting
- Juntendo University HospitalRecruiting
- Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome HospitalRecruiting
- The Cancer Institute Hospital of JFCRRecruiting
- Toho University Omori Medical CenterRecruiting
- NHO Iwakuni Clinical CenterRecruiting
- Yamaguchi-Ube Medical CenterRecruiting
- Teine Keijinkai HospitalRecruiting
- Chungbuk National University HospitalRecruiting
- Seoul National University Bundang HospitalRecruiting
- Kyungpook National University Chilgok HospitalRecruiting
- National Cancer CenterRecruiting
- Samsung Medical CenterRecruiting
- The Catholic Univ. of Korea, Seoul St. Mary'S HospitalRecruiting
- Asan Medical CenterRecruiting
- Cryptex Investigacion Clinica Sa de CvRecruiting
- Hospital Civil de Guadalajara Fray Antonio AlcaldeRecruiting
- Hospital Universitario Dr. Jose Eleuterio GonzalezRecruiting
- Centro de Investigacion Clinica de Oaxaca (CICLO)Recruiting
- Oncologico PotosinoRecruiting
- Rijnstate ZiekenhuisRecruiting
- Amsterdam Umc, Location VumcRecruiting
- Leiden University Medical CenterRecruiting
- Jeroen Bosch Ziekenhuis J BZ Hieronymus Bosch HospitalRecruiting
- Instytut Centrum Zdrowia Matki PolkiRecruiting
- Dom Lekarski SARecruiting
- II Klinika Chorob Pluc I GruzlicyRecruiting
- Centro Clinico ChampalimauRecruiting
- Centro Hospitalar e Universitário do PortoRecruiting
- Hospital CUF PortoRecruiting
- Onco Clinic Consult SARecruiting
- Sc Sigmedical Services SrlRecruiting
- Oncocenter-Oncologie Clinica SRLRecruiting
- SC Oncomed SRLRecruiting
- Hospital Clinic i Provincial de BarcelonaRecruiting
- Hospital Universitari Vall D'HebronRecruiting
- Hospital Universitario Arnau de Vilanova - LleidaRecruiting
- Hospital General Universitario Gregorio MarañonRecruiting
- Hospital Clinico San CarlosRecruiting
- Hospital Universitario Fundacion Jimenez DiazRecruiting
- Hospital Regional Universitario MalagaRecruiting
- CHUORecruiting
- Hospital Universitario Virgen MacarenaRecruiting
- Hospital Universitari i Politècnic La FeRecruiting
- Hospital Universitario Miguel ServetRecruiting
- Kantonsspital BadenRecruiting
- University Hospital BaselRecruiting
- Kantonsspital BasellandRecruiting
- E-Da HospitalRecruiting
- Chang Gung Memorial Hospital Cgmh - Kaohsiung BranchRecruiting
- Chung Shan Medical University HospitalRecruiting
- Taichung Veterans General HospitalRecruiting
- National Cheng Kung University Hospital NckuhRecruiting
- Taipei Veterans General HospitalRecruiting
- National Taiwan University HospitalRecruiting
- Koo Foundation Sun Yat-Sen Cancer CenterRecruiting
- Chang Gung Memorial Hospital LinKouRecruiting
- Srinagarind HospitalRecruiting
- Prince of Songkla University PSU - Faculty of MedicineRecruiting
- Faculty of Medicine Chulalongkorn UniversityRecruiting
- Siriraj HospitalRecruiting
- Birmingham Heartlands HospitalRecruiting
- Beatson West of Scotland Cancer CentreRecruiting
- Nottingham University HospitalsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pembrolizumab + Datopotamab Deruxtecan (Dato-DXd)
Pembrolizumb
Arm Description
Participants will be randomized to receive 200 mg pembrolizumab followed by 6.0mg/kg Dato-DXd.
Participants will be randomized to receive 200 mg pembrolizumab.
Outcomes
Primary Outcome Measures
Progression-free Survival Based on Blinded Independent Central Review in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Progression-free Survival (PFS) is defined as the time from randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1.
Overall Survival in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Overall Survival (OS) is defined as the time from randomization to death due to any cause.
Secondary Outcome Measures
Objective Response Rate by Blinded Independent Central Review in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Objective Response Rate (ORR) is defined as the proportion of participants who achieved a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), assessed by BICR per RECIST Version 1.1.
Progression-free Survival by Investigator in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Progression-free Survival (PFS) is defined as the time from randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed by the Investigator per RECIST Version 1.1.
Progression-free Survival 2 in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Progression-free Survival 2 (PFS2) is defined as the time from randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed by local standard clinical practice.
Objective Response Rate by Investigator in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Objective Response Rate (ORR) is defined as the proportion of participants who achieved a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), assessed by the Investigator per RECIST Version 1.1.
Duration of Response by BICR and Investigator in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Duration of Response (DoR) is defined as the time from the date of the first documentation of objective response (confirmed CR or confirmed PR) to the date of the first radiographic disease progression or death due to any cause, whichever occurs first, assessed by BICR and by the Investigator per RECIST Version 1.1.
Time to Response by BICR and Investigator in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Time to Response (TTR) is defined as the time from randomization to the date of the first documentation of objective response (confirmed CR or confirmed PR) in responding participants, assessed by BICR and by the Investigator per RECIST Version 1.1.
Disease Control Rate by BICR and Investigator in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Disease Control Rate (DCR) is defined as the proportion of participants who achieved a BOR of confirmed CR, confirmed PR, or stable disease (SD), assessed by BICR and by the Investigator per RECIST Version 1.1.
Time to Deterioration in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Time to Deterioration (TTD) is defined as the time from randomization to first onset of a ≥10-point increase in cough, chest pain, or dyspnea, confirmed by a second adjacent ≥10-point increase from randomization in the same symptom, or confirmed by death within 21 days of a ≥10-point increase from randomization, assessed the European Organization for Research and Treatment of Cancer Lung cancer module (EORTC-QLQ-LC13).
Number of Participants With Treatment-emergent Adverse Events (TEAE) Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
A TEAE is defined as an AE with a start or worsening date on or after the start date of study treatment until 37 days after the end date of study treatment.
Proportion of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline) and Proportion of Participants Who Have Treatment-emergent ADA
The immunogenicity of Dato-DXd in combination with pembrolizumab will be assessed.
Full Information
NCT ID
NCT05215340
First Posted
January 18, 2022
Last Updated
October 17, 2023
Sponsor
Daiichi Sankyo, Inc.
Collaborators
AstraZeneca, Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT05215340
Brief Title
Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionable Genomic Alterations
Acronym
TROPION-Lung08
Official Title
A Randomized, Open-label, Phase 3 Trial of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in Treatment-naïve Subjects With Advanced or Metastatic PD-L1 High (TPS ≥50%) Non-small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung08)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 4, 2022 (Actual)
Primary Completion Date
June 2026 (Anticipated)
Study Completion Date
June 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo, Inc.
Collaborators
AstraZeneca, 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
This study is designed to assess the efficacy and safety of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab versus pembrolizumab alone in participants with advanced or metastatic non-small cell lung cancer (NSCLC).
Detailed Description
The primary objective of the study is to compare the efficacy of Dato-DXd and pembrolizumab with pembrolizumab alone in terms of either Progression Free Survival (PFS) or Overall Survival (OS) for participants with advanced or metastatic NSCLC without actionable genomic alterations whose tumor has high programmed death-ligand 1 (PD-L1) expression (tumor proportion score; TPS ≥50%) and who have not previously received systemic therapy for advanced or metastatic NSCLC.
Eligible participants will be randomized in a 1:1 ratio to the control arm (pembrolizumab alone) or the experimental arm (Dato-DXd and pembrolizumab). The study will be divided into 4 periods: Tissue Screening Period, Screening Period, Treatment Period, and Follow-up Period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Non Small Cell Lung Cancer
Keywords
Metastatic Non Small Cell Lung Cancer, Advanced Non Small Cell Lung Cancer, Datopotamab Deruxtecan (Dato-DXd), Pembrolizumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
740 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pembrolizumab + Datopotamab Deruxtecan (Dato-DXd)
Arm Type
Experimental
Arm Description
Participants will be randomized to receive 200 mg pembrolizumab followed by 6.0mg/kg Dato-DXd.
Arm Title
Pembrolizumb
Arm Type
Active Comparator
Arm Description
Participants will be randomized to receive 200 mg pembrolizumab.
Intervention Type
Drug
Intervention Name(s)
Datopotamab Deruxtecan
Other Intervention Name(s)
Dato-DXd
Intervention Description
Dato-DXd will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Intervention Description
Pembrolizumab will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.
Primary Outcome Measure Information:
Title
Progression-free Survival Based on Blinded Independent Central Review in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Description
Progression-free Survival (PFS) is defined as the time from randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1.
Time Frame
From randomization until disease progression or death (whichever occurs first), up to approximately 32 months
Title
Overall Survival in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Description
Overall Survival (OS) is defined as the time from randomization to death due to any cause.
Time Frame
From randomization until date of death due to any cause, up to approximately 53 months
Secondary Outcome Measure Information:
Title
Objective Response Rate by Blinded Independent Central Review in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Description
Objective Response Rate (ORR) is defined as the proportion of participants who achieved a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), assessed by BICR per RECIST Version 1.1.
Time Frame
From randomization until disease progression or death (whichever occurs first), up to approximately 32 months
Title
Progression-free Survival by Investigator in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Description
Progression-free Survival (PFS) is defined as the time from randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed by the Investigator per RECIST Version 1.1.
Time Frame
From randomization until disease progression or death (whichever occurs first), up to approximately 32 months
Title
Progression-free Survival 2 in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Description
Progression-free Survival 2 (PFS2) is defined as the time from randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed by local standard clinical practice.
Time Frame
From randomization until disease progression or death (whichever occurs first), up to approximately 53 months
Title
Objective Response Rate by Investigator in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Description
Objective Response Rate (ORR) is defined as the proportion of participants who achieved a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), assessed by the Investigator per RECIST Version 1.1.
Time Frame
From randomization until disease progression or death (whichever occurs first), up to approximately 32 months
Title
Duration of Response by BICR and Investigator in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Description
Duration of Response (DoR) is defined as the time from the date of the first documentation of objective response (confirmed CR or confirmed PR) to the date of the first radiographic disease progression or death due to any cause, whichever occurs first, assessed by BICR and by the Investigator per RECIST Version 1.1.
Time Frame
From date of first objective response (CR or PR) to date of first radiographic disease progression or death due to any cause (whichever occurs first), up to approximately 32 months
Title
Time to Response by BICR and Investigator in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Description
Time to Response (TTR) is defined as the time from randomization to the date of the first documentation of objective response (confirmed CR or confirmed PR) in responding participants, assessed by BICR and by the Investigator per RECIST Version 1.1.
Time Frame
From randomization to date of first objective response (CR or PR), up to approximately 32 months
Title
Disease Control Rate by BICR and Investigator in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Description
Disease Control Rate (DCR) is defined as the proportion of participants who achieved a BOR of confirmed CR, confirmed PR, or stable disease (SD), assessed by BICR and by the Investigator per RECIST Version 1.1.
Time Frame
From randomization until disease progression or death (whichever occurs first), up to approximately 32 months
Title
Time to Deterioration in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Description
Time to Deterioration (TTD) is defined as the time from randomization to first onset of a ≥10-point increase in cough, chest pain, or dyspnea, confirmed by a second adjacent ≥10-point increase from randomization in the same symptom, or confirmed by death within 21 days of a ≥10-point increase from randomization, assessed the European Organization for Research and Treatment of Cancer Lung cancer module (EORTC-QLQ-LC13).
Time Frame
From randomization until disease progression or death (whichever occurs first), up to approximately 53 months
Title
Number of Participants With Treatment-emergent Adverse Events (TEAE) Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Description
A TEAE is defined as an AE with a start or worsening date on or after the start date of study treatment until 37 days after the end date of study treatment.
Time Frame
Up to 53 months
Title
Proportion of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline) and Proportion of Participants Who Have Treatment-emergent ADA
Description
The immunogenicity of Dato-DXd in combination with pembrolizumab will be assessed.
Time Frame
Baseline and up to 53 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants eligible for inclusion in the study must meet all inclusion criteria within 28 days of randomization into the study.
Sign and date the Tissue Screening and Main Informed Consent Forms, prior to the start of any study-specific qualification procedures.
Adults ≥18 years or the minimum legal adult age (whichever is greater) at the time of informed consent.
Histologically documented NSCLC that meets all of the following criteria:
Stage IIIB or IIIC disease and not candidates for surgical resection or definitive chemoradiation, or Stage IV NSCLC disease at the time of randomization (based on the American Joint Committee on Cancer, Eighth Edition). Participants with early-stage NSCLC who have relapsed should be restaged during screening to ensure their eligibility for the study.
Documented negative test results for epidermal growth factor receptor (EGFR), lymphoma kinase (ALK), and proto-oncogene1 (ROS1) actionable genomic alterations based on analysis of tumor tissue.
No known actionable genomic alterations in neurotrophic tyrosine receptor kinase (NTRK), proto-oncogene B-raf (BRAF), rearranged during transfection (RET), mesenchymal-epithelial transition factor (MET), or other actionable driver kinases with locally approved therapies.
Has provided a formalin-fixed tumor tissue sample for the measurement of trophoblast cell surface protein 2 (TROP2) protein expression and for the assessment of other exploratory biomarkers.
Tumor has high programmed death receptor-1 (PD-L1) expression (TPS ≥50%) as determined by PD-L1 immunohistochemistry (IHC) 22C3 pharmDx assay by central testing (minimum of 6 slides).
Has an adequate treatment washout period before Cycle 1 Day 1.
Measurable disease based on local imaging assessment using RECIST Version 1.1.
Has left ventricular ejection fraction (LVEF) ≥50% by either an echocardiogram (ECHO) or multigated acquisition scan (MUGA) within 28 days before randomization.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at screening.
Has a life expectancy of at least 3 months.
Adequate bone marrow function within 7 days before randomization.
Exclusion Criteria:
Has received prior systemic treatment for advanced or metastatic NSCLC.
Has received prior treatment for NSCLC with any of the following, including in the adjuvant/neoadjuvant setting:
Any agent, including an antibody-drug conjugate, containing a chemotherapeutic agent targeting topoisomerase I.
TROP2-targeted therapy.
Any anti-programmed death receptor-1 (PD-1), anti-PD-L1, or anti-PD-ligand 2 (L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX40, CD137).
Any other immune checkpoint inhibitors. Participants who received adjuvant or neoadjuvant therapy OTHER than those listed above, are eligible if the adjuvant/neoadjuvant therapy was completed at least 6 months prior to the diagnosis of advanced/metastatic disease.
Has spinal cord compression or active and untreated central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable.
Has received prior radiotherapy ≤4 weeks of start of study intervention or more than 30 Gy (unit of ionizing radiation dose in the International System of Units) to the lung within 6 months of Cycle 1 Day 1.
History of another primary malignancy (beyond NSCLC) except for:
Malignancy treated with curative intent and with no known active disease ≥3 years before the first dose of study treatment and of low potential risk for recurrence.
Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
Adequately treated carcinoma in situ without evidence of disease.
Participants with a history of prostate cancer (tumor/node/metastasis stage) of Stage ≤T2cN0M0 without biochemical recurrence or progression and who in the opinion of the Investigator are not deemed to require active intervention.
Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis including radiation pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
Clinically severe pulmonary compromise, as judged by the investigator, resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder, or any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement or prior complete pneumonectomy.
Uncontrolled or significant cardiovascular disease, including:
Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) interval >470 msec regardless of sex (based on the average of the 12-lead electrocardiogram determination at screening).
Myocardial infarction within 6 months prior to randomization.
Uncontrolled angina pectoris within 6 months prior to randomization.
LVEF <50% by ECHO or MUGA scan within 28 days before randomization.
New York Heart Association Class 2 to 4 congestive heart failure (CHF) at screening.
Uncontrolled hypertension (resting systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg) within 28 days before randomization.
Participants with a history of Class 2 to 4 CHF prior to screening, must have returned to Class 1 CHF and have LVEF ≥50% (by either an ECHO or MUGA scan within 28 days before randomization) in order to be eligible.
Clinically significant corneal disease.
Has received a live vaccine or live-attenuated vaccine (messenger ribonucleic acid and replication-incompetent adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first dose of study drug. For any participant receiving an approved severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccine, please follow the vaccine label and/or local guidance.
Active, known, or suspected autoimmune disease (has an active autoimmune disease that has required systemic treatment in the past 2 years).
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosage >10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy ≤7 days prior to the first dose of study drug.
Has known human immunodeficiency virus (HIV) infection that is not well controlled.
Has an active hepatitis or uncontrolled hepatitis B or active hepatitis C infection.
Has an uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
Had an allogeneic tissue/solid organ transplant.
Has a history of severe hypersensitivity reactions to either the drug or inactive ingredients (including but not limited to polysorbate 80) of Dato-DXd or pembrolizumab.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
(US Sites) Daiichi Sankyo Contact for Clinical Trial Information
Phone
908-992-6400
Email
CTRinfo@dsi.com
First Name & Middle Initial & Last Name or Official Title & Degree
(Asia Sites) Daiichi Sankyo Contact for Clinical Trial Informat
Phone
+81-3-6225-1111(M-F 9-5 JST)
Email
dsclinicaltrial@daiichisankyo.co.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Leader
Organizational Affiliation
Daiichi Sankyo, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Ironwood Cancer and Research Center
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
Principal Investigator
Facility Name
UCLA HemOnc - Clinical Research Unit
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Name
Compassionate Cancer Care Medical Group
City
Riverside
State/Province
California
ZIP/Postal Code
92501
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
UCSF Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Recruiting
Facility Name
Ridley-Tree Cancer Center
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Individual Site Status
Recruiting
Facility Name
PIH Health Whittier Hospital
City
Whittier
State/Province
California
ZIP/Postal Code
90602
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
The Oncology Institute of Hope and Innovation
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Uch-Mhs D/B/A Memorial Health System
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
American Oncology Partners of Maryland
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03766
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Astera Cancer Care
City
East Brunswick
State/Province
New Jersey
ZIP/Postal Code
08816
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Regional Cancer Care Associates LLC
City
Freehold
State/Province
New Jersey
ZIP/Postal Code
07728
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Cooperman Barnabas Medical Center
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
Principal Investigator
Facility Name
The Valley Hospital
City
Paramus
State/Province
New Jersey
ZIP/Postal Code
07652
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Arizona Oncology NAHOA
City
Irving
State/Province
Texas
ZIP/Postal Code
75063
Country
United States
Individual Site Status
Recruiting
Facility Name
Cancer Care Center of Brevard
City
Irving
State/Province
Texas
ZIP/Postal Code
75063
Country
United States
Individual Site Status
Recruiting
Facility Name
Maryland Oncology Hematology
City
Irving
State/Province
Texas
ZIP/Postal Code
75063
Country
United States
Individual Site Status
Recruiting
Facility Name
Southern Cancer Center
City
Irving
State/Province
Texas
ZIP/Postal Code
75063
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology - Northeast Texas
City
Irving
State/Province
Texas
ZIP/Postal Code
75063
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology Gulf Coast
City
Irving
State/Province
Texas
ZIP/Postal Code
75063
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology McAllen
City
Irving
State/Province
Texas
ZIP/Postal Code
75063
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Texas Health Science Center San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Utah Cancer Specialists
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Providence Regional Cancer System
City
Lacey
State/Province
Washington
ZIP/Postal Code
98503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Fundacion CENIT para la investigación en Neurociencias
City
Ciudad Autonoma de Buenos Aire
ZIP/Postal Code
1125
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Centro de Investigación Pergamino S. A.
City
Pergamino
ZIP/Postal Code
2700
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Instituto de Oncología de Rosario
City
Rosario
ZIP/Postal Code
S2000
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Sanatorio Parque
City
Rosario
ZIP/Postal Code
S2001
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Sanatorio Británico de Rosario
City
Rosario
ZIP/Postal Code
S2002
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Clinica Viedma SA
City
Viedma
ZIP/Postal Code
8500
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Austin Hospital
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Peninsula and South Eastern Haematology and Oncology Group
City
Mount Waverley
State/Province
Victoria
ZIP/Postal Code
3149
Country
Australia
Individual Site Status
Recruiting
Facility Name
Chris Obrien Lifehouse
City
Camperdown
ZIP/Postal Code
2050
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
The Queen Elizabeth Hospital
City
Woodville South
ZIP/Postal Code
5011
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Onze-Lieve-Vrouwziekenhuis Olvz - Campus Aalst
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Grand Hopital de Charleroi - Hopital Saint Joseph
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Az Maria Middelares - Campus Maria Middelares
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
AZ Nikolaas
City
Sint-Niklaas
ZIP/Postal Code
9100
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Instituto de Pesquisas em Saúde - IPS
City
Caxias Do Sul
ZIP/Postal Code
95020-972
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Oncosite - Centro de Pesquisa Clinica Oncologia
City
Ijui
ZIP/Postal Code
98700-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
UPCO - Unidade de Pesquisas Clínicas em Oncologia - Clinica Lacks
City
Pelotas
ZIP/Postal Code
96020-080
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Santa Casa de Misericordia de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
90050-170
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Instituto Nacional de Câncer - INCA
City
Rio De Janeiro
ZIP/Postal Code
20231-050
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Centro de Estudos e Pesquisa de Hematologia e Oncologia - CEPHO
City
Santo Andre
ZIP/Postal Code
09060-870
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Instituto de Ensino e Pesquisas Sao Lucas
City
Sao Paulo
ZIP/Postal Code
01236-030
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Santa Cabrini Hospital
City
Montréal
ZIP/Postal Code
H1T 2M4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Centro de Estudios Clínicos SAGA
City
Santiago de Chile
State/Province
Metropolitana
ZIP/Postal Code
7500653
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Oncovida
City
Santiago
ZIP/Postal Code
7500000
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Fundación Arturo Pérez López
City
Santiago
ZIP/Postal Code
7500921
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Centro de Investigaciones Clinicas Vina Del Mar
City
Vina Del Mar
ZIP/Postal Code
254-0488
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Guangxi Medical University Affiliated Tumor Hospital
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Jilin Cancer Hospital
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130012
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Peking University Peoples Hospital
City
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Peking University Cancer Hospital
City
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Hunan Cancer Hospital
City
Changsha
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
City
Guangzhou
ZIP/Postal Code
510095
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Haikou People's Hospital
City
Haikou
ZIP/Postal Code
570208
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
The First Affiliated Hospital of College of Medicine Zhejiang University
City
Hanghzou
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
ZIP/Postal Code
310022
Country
China
Individual Site Status
Withdrawn
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
ZIP/Postal Code
150081
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Inner Mongolia Medical University- the Affiliated Hospital
City
Hohhot
ZIP/Postal Code
10050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Jiamusi Tumor and Tuberculosis Hospital
City
Jiamusi
ZIP/Postal Code
154007
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Yunnan Cancer Hospital
City
Kunming
ZIP/Postal Code
650118
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Linyi Cancer Hospital
City
Linyi
ZIP/Postal Code
276000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Jiangsu Province Hospital
City
Nanjing
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
The Second People's Hospital of Neijiang
City
Neijiang
ZIP/Postal Code
641000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai Shi
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Liaoning Cancer Hospital& Institute
City
Shenyang City
ZIP/Postal Code
110801
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
The First Hospital of China Medical University
City
Shenyang
ZIP/Postal Code
110001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Union Hospital Affiliated With Tongji Medical College Huazhong University of Science and Technology
City
Wuhan
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Hubei Cancer Hospital
City
Wuhan
ZIP/Postal Code
430079
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
The First Affiliate Hospitalof Xi'An Jiaotong University
City
Xi'an
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
The First Affiliated Hospital Xiamen University
City
Xiamen
ZIP/Postal Code
361001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Xinjiang Tumor Hospital
City
Ürümqi
ZIP/Postal Code
830000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Bordeaux University Hospital - Hopital Saint Andre
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Centre Hospitalier Universitaire de Lille
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69008
Country
France
Individual Site Status
Recruiting
Facility Name
APHM - Hopital Nord
City
Marseille
ZIP/Postal Code
13015
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Centre Hospitalier Universitaire de Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Hopital prive du Confluent
City
Nantes Cedex 2
ZIP/Postal Code
44277
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
AP-HP - Hopital Tenon
City
Paris
ZIP/Postal Code
75970
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
CHU de Poitier Pole Regional de Cancerologie
City
Poitiers
ZIP/Postal Code
86000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Hopital FOCH
City
Suresnes
ZIP/Postal Code
92150
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Evangelische Lungenklinik Berlin
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Klinikum Esslingen GmbH
City
Esslingen
ZIP/Postal Code
73730
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
LungenClinic Grosshansdorf
City
Grosshansdorf
ZIP/Postal Code
22927
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Klinikum der Universitaet Muenchen
City
Muenchen
ZIP/Postal Code
80336
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Metropolitan Hospital
City
Neo Faliro
State/Province
Athens
ZIP/Postal Code
14564
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Sotiria General Hosptial of Chest Diseases
City
Athens
ZIP/Postal Code
11527
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
University Hospital of Ioannina Uhi
City
Ioannina
ZIP/Postal Code
45500
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Metropolitan Hospital
City
Neo Faliro
ZIP/Postal Code
18547
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Bioclinic Thessaloniki
City
Thessaloniki
ZIP/Postal Code
54622
Country
Greece
Individual Site Status
Recruiting
Facility Name
Prince of Wales Hospital / The Chinese University of Hong Kong 99999
City
Hong Kong
ZIP/Postal Code
99999
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Queen Elizabeth Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Queen Mary Hospital
City
Pok Fu Lam
ZIP/Postal Code
999077
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Semmelweis University Department of Pulmonology
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Veszprem Megyei Tudogyogyintezet Farkasgyepu
City
Farkasgyepű
ZIP/Postal Code
8582
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Bkmk Hospital
City
KecskemĂŠt
ZIP/Postal Code
6000
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Pulmonology Hospital Torokbalint
City
Torokbalint
ZIP/Postal Code
2045
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
IRCCS Istituto Oncologico Giovanni Paolo II
City
Bari
ZIP/Postal Code
70124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
UOC Oncologia
City
Chieti
ZIP/Postal Code
66100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
IRCCS Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Irccs Istituto Europeo Di Oncologia
City
Milano
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Azienda Ospedaliera dei Colli
City
Naples
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
A.O. Perugia Santa Maria della Misericordia
City
Perugia
ZIP/Postal Code
06132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Policlinico Tor Vergata
City
Rome
ZIP/Postal Code
133
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Ifo Regina Elena
City
Rome
ZIP/Postal Code
144
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Asst Sette Laghi Ospedale di Circolo e Fondazione Macchi
City
Varese
ZIP/Postal Code
21100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Aomori Prefectural Central Hospital
City
Aomori-shi
State/Province
Aomori
ZIP/Postal Code
030-8553
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
National Cancer Center Hospital East
City
Kashiwa-shi
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
NHO Shikoku Cancer Center
City
Matsuyama-shi
State/Province
Ehime
ZIP/Postal Code
791-0280
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
National Hospital Organization Kyushu Cancer Center
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Kyushu University Hospital
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Kurume University Hospital
City
Kurume-shi
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Kanazawa University Hospital
City
Kanazawa-shi
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Kanagawa Cancer Center
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Saiseikai Kumamoto Hospital
City
Kumamoto-shi
State/Province
Kumamoto
ZIP/Postal Code
861- 4193
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Matsusaka Municipal Hospital
City
Matsusaka-shi
State/Province
Mie
ZIP/Postal Code
515-8544
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Sendai Kousei Hospital
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
980-0873
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Niigata Cancer Center Hospital
City
Niigata-shi
State/Province
Niigata
ZIP/Postal Code
961-8566
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Kansai Medical University Hospital
City
Hirakata-shi
State/Province
Osaka
ZIP/Postal Code
573-1191
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Osaka International Cancer Institute
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
NHO Kinki-Chuo Chest Medical Center
City
Sakai-shi
State/Province
Osaka
ZIP/Postal Code
591-8555
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Saitama Cancer Center
City
Ina-machi
State/Province
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Dokkyo Medical University Hospital
City
Shimotsuga-gun
State/Province
Tochigi
ZIP/Postal Code
321-0293
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Juntendo University Hospital
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
City
Bunkyō-Ku
State/Province
Tokyo
ZIP/Postal Code
113-8677
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
The Cancer Institute Hospital of JFCR
City
Koto-ku
State/Province
Toyko
ZIP/Postal Code
135-8550
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Toho University Omori Medical Center
City
Ota-ku
State/Province
Toyko
ZIP/Postal Code
143-8541
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
NHO Iwakuni Clinical Center
City
Iwakuni-shi
State/Province
Yamaguchi
ZIP/Postal Code
740-8510
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Yamaguchi-Ube Medical Center
City
Ube-shi
State/Province
Yamaguchi
ZIP/Postal Code
755-0241
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Teine Keijinkai Hospital
City
Sapporo
ZIP/Postal Code
006-8555
Country
Japan
Individual Site Status
Recruiting
Facility Name
Chungbuk National University Hospital
City
Cheongju-si
State/Province
Chungbuk
ZIP/Postal Code
28644
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Kyungpook National University Chilgok Hospital
City
Daegu
ZIP/Postal Code
42119
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
National Cancer Center
City
Goyang-si
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
6351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
The Catholic Univ. of Korea, Seoul St. Mary'S Hospital
City
Seoul
ZIP/Postal Code
6591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Asan Medical Center
City
Songpa-gu
ZIP/Postal Code
5505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Cryptex Investigacion Clinica Sa de Cv
City
Cuauhtémoc
ZIP/Postal Code
06100
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Hospital Civil de Guadalajara Fray Antonio Alcalde
City
Guadalajara
ZIP/Postal Code
44280
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Hospital Universitario Dr. Jose Eleuterio Gonzalez
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Centro de Investigacion Clinica de Oaxaca (CICLO)
City
Oaxaca de Juarez
ZIP/Postal Code
68020
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Oncologico Potosino
City
San Luis Potosí
ZIP/Postal Code
78209
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Rijnstate Ziekenhuis
City
Arnhem
State/Province
Gelderland
ZIP/Postal Code
6815 AD
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Amsterdam Umc, Location Vumc
City
Amsterdam
ZIP/Postal Code
1081 HZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Jeroen Bosch Ziekenhuis J BZ Hieronymus Bosch Hospital
City
s-Hertogenbosch
ZIP/Postal Code
5223 GZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Instytut Centrum Zdrowia Matki Polki
City
Lodz
State/Province
Iodzkie
ZIP/Postal Code
93-338
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Dom Lekarski SA
City
Szczecin
State/Province
Zachodniopomorskie
ZIP/Postal Code
70-784
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
II Klinika Chorob Pluc I Gruzlicy
City
Bialystok
ZIP/Postal Code
15-450
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Centro Clinico Champalimau
City
Lisboa
ZIP/Postal Code
1400-038
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Centro Hospitalar e Universitário do Porto
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Hospital CUF Porto
City
Porto
ZIP/Postal Code
4100-180
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Onco Clinic Consult SA
City
Craiova
ZIP/Postal Code
200094
Country
Romania
Individual Site Status
Recruiting
Facility Name
Sc Sigmedical Services Srl
City
Suceava
ZIP/Postal Code
720214
Country
Romania
Individual Site Status
Recruiting
Facility Name
Oncocenter-Oncologie Clinica SRL
City
Timisoara
ZIP/Postal Code
300166
Country
Romania
Individual Site Status
Recruiting
Facility Name
SC Oncomed SRL
City
Timisoara
ZIP/Postal Code
300239
Country
Romania
Individual Site Status
Recruiting
Facility Name
Hospital Clinic i Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Hospital Universitari Vall D'Hebron
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Hospital Universitario Arnau de Vilanova - Lleida
City
Lleida
ZIP/Postal Code
25198
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Hospital Universitario Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Hospital Regional Universitario Malaga
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
CHUO
City
Ourense
ZIP/Postal Code
32005
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Hospital Universitari i Politècnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Kantonsspital Baden
City
Baden
ZIP/Postal Code
5404
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
University Hospital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Kantonsspital Baselland
City
Liestal
ZIP/Postal Code
A4410
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
E-Da Hospital
City
Kaohsiung City
ZIP/Postal Code
824
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Chang Gung Memorial Hospital Cgmh - Kaohsiung Branch
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Chung Shan Medical University Hospital
City
Taichung
ZIP/Postal Code
40201
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
National Cheng Kung University Hospital Nckuh
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Taipei Veterans General Hospital
City
Taipei City
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Koo Foundation Sun Yat-Sen Cancer Center
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Chang Gung Memorial Hospital LinKou
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Srinagarind Hospital
City
Muaeng
State/Province
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Prince of Songkla University PSU - Faculty of Medicine
City
Hat Yai
State/Province
Songkhla
ZIP/Postal Code
90110
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Faculty of Medicine Chulalongkorn University
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Siriraj Hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Birmingham Heartlands Hospital
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Nottingham University Hospitals
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
IPD Sharing Time Frame
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
IPD Sharing Access Criteria
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
IPD Sharing URL
https://vivli.org/ourmember/daiichi-sankyo/
Learn more about this trial
Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionable Genomic Alterations
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