Back to resultsEfficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) in Adults With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Treatment-naïve Nonsmall Cell Lung Cancer (NSCLC) (MK-7902-007/E7080-G000-314/LEAP-007)
Primary Purpose
Non-small Cell Lung Cancer
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pembrolizumab
Lenvatinib
Placebo for lenvatinib
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring programmed cell death 1 (PD-1, PD1), programmed cell death-ligand 1 (PD-L1, PDL1), programmed cell death-ligand 2 (PD-L2, PDL2)
Eligibility Criteria
Inclusion Criteria:
- Has a histologically or cytologically confirmed diagnosis of NSCLC.
- Has Stage IV NSCLC (American Joint Committee on Cancer [AJCC 8th edition]).
- Has measurable disease based on RECIST 1.1.
- Has tumor tissue that demonstrates programmed cell death-ligand 1 (PD-L1) expression in ≥1% of tumor cells (Tumor Proportion Score [TPS] ≥1%) as assessed by immunohistochemistry (IHC) 22C3 pharmDx assay (Dako North America, Inc.) at a central laboratory.
- Has a life expectancy of ≥3 months.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose of study treatment but before randomization.
- Male participants must agree to the following during the treatment period and for ≥7 days after the last dose of lenvatinib/matching placebo: 1) Be abstinent from heterosexual intercourse as their preferred and usual lifestyle and agree to remain abstinent, OR 2) Must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause).
- Female participants are eligible to participate if not pregnant or breastfeeding, and ≥1 of the following applies: 1) Is not a woman of child-bearing potential (WOCBP), OR 2) Is a WOCBP and is using a highly effective contraceptive method that has a low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle during the treatment period and for ≥120 days post pembrolizumab or ≥30 days post lenvatinib/matching placebo, whichever occurs last.
- Has adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤150/90 mm Hg and no change in antihypertensive medications within 1 week before randomization.
- Has adequate organ function.
Exclusion Criteria:
- Has known untreated central nervous system metastases and/or carcinomatous meningitis.
- Has active hemoptysis (at least 0.5 teaspoon of bright red blood) within 2 weeks prior to the first dose of study intervention.
- Has radiographic evidence of intratumoral cavitations, encasement, or invasion of a major blood vessel.
- Has a known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for ≥3 years since initiation of that therapy. (Note: The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers.)
- Has an active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
- Has had an allogeneic tissue/solid organ transplant.
- Has a known history of human immunodeficiency virus (HIV) infection.
- Has a history of (noninfectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease.
- Has a known history of hepatitis B or known active hepatitis C virus infection.
- Has a history of a gastrointestinal condition or procedure that in the opinion of the investigator may affect oral study drug absorption.
- Has significant cardiovascular impairment within 12 months of the first dose of study treatment, such as a history of congestive heart failure greater than New York Heart Association Class II, unstable angina, myocardial infarction, cerebrovascular accident/stroke, or cardiac arrhythmia associated with hemodynamic instability.
- Has not recovered adequately from any toxicity and/or complications from major surgery before starting study treatment.
- Has a known history of active tuberculosis (TB).
- Has an active infection requiring systemic therapy.
- Has previously had a severe hypersensitivity reaction to treatment with a monoclonal antibody or has a known sensitivity or intolerance to any component of lenvatinib or pembrolizumab.
- Has received prior systemic chemotherapy or other targeted or biological antineoplastic therapy for their metastatic NSCLC.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], Tumor necrosis factor receptor superfamily, member 4 [OX 40], tumor necrosis factor receptor superfamily member 9 [CD137]) or has received lenvatinib as monotherapy or in combination with anti- programmed cell death protein (anti-PD-1) agents.
- Has received radiotherapy within 14 days before the first dose of study treatment or received lung radiation therapy of >30 Gray (Gy) within 6 months before the first dose of study treatment. (Note: Participants must have recovered from all radiation-related toxicities to ≤Grade 1, not require corticosteroids, and not have had radiation pneumonitis.)
- Has a diagnosis of immunodeficiency or is receiving any form of immunosuppressive therapy within 7 days before the first dose of study treatment.
- Is receiving systemic steroid therapy (doses >10 mg daily of prednisone equivalent) within 7 days before the first dose of study treatment.
- Has received a live or attenuated vaccine within 30 days before the first dose of study treatment.
- Has had major surgery within 3 weeks prior to first dose of study treatment
- Has pre-existing ≥Grade 3 gastrointestinal or nongastrointestinal fistula.
Sites / Locations
- Alaska Clinical Research Center ( Site 0511)
- Ironwood Cancer & Research Centers ( Site 0541)
- CBCC Global Research, Inc. ( Site 0532)
- Scripps Cancer Center ( Site 0521)
- Florida Hospital ( Site 0526)
- Northwest Georgia Oncology Centers PC ( Site 0518)
- Illinois Cancer Care, PC ( Site 0557)
- Parkview Cancer Center ( Site 0542)
- University of Kentucky School of Medicine & Hospitals ( Site 0517)
- Anne Arundel Medical Center Oncology and Hematology ( Site 0514)
- Munson Medical Center ( Site 0512)
- Park Nicollet Frauenshuh Cancer Center ( Site 0554)
- University of Missouri Health Care ( Site 0555)
- Billings Clinic Cancer Center ( Site 0508)
- Cone Health Cancer Center at Alamance Regional ( Site 0527)
- Genesis Cancer Care Center ( Site 0559)
- Oregon Health Sciences University ( Site 0544)
- Central Texas Veterans Healthcare System ( Site 0533)
- Orange Health Services ( Site 0002)
- Wollongong Private Hospital ( Site 0005)
- The Prince Charles Hospital ( Site 0011)
- Ballarat Oncology and Haematology Services ( Site 0008)
- St John of God Murdoch Medical Clinic ( Site 0001)
- Cross Cancer Institute ( Site 0400)
- Lions Gate Hospital ( Site 0407)
- William Osler Health System (Brampton Civic Hospital) ( Site 0402)
- Windsor Regional Cancer Program ( Site 0404)
- McGill University Health Centre ( Site 0418)
- Beijing Chest Hospital Capital Medical University ( Site 0111)
- Anhui Provincial Hospital ( Site 0108)
- The First Affiliated Hospital of Anhui Medical University ( Site 0113)
- Peking Union Medical College Hospital ( Site 0105)
- Beijing Cancer Hospital ( Site 0102)
- Xiangya Hospital of Central South University ( Site 0115)
- Hunan Cancer Hospital ( Site 0104)
- Jiangsu Cancer Hospital ( Site 0101)
- The First Hospital of Jilin University ( Site 0110)
- Zhongshan Hospital Fudan University ( Site 0100)
- Shanghai Chest Hospital ( Site 0112)
- 1st Affil Hosp of Med College of Xi'an Jiaotong University ( Site 0103)
- West China Hospital of Sichuan University ( Site 0117)
- The First Affiliated Hospital Zhejiang University ( Site 0106)
- Hangzhou First People's Hospital ( Site 0109)
- 2nd Affil Hosp of Zhejiang University College of Medicine ( Site 0114)
- Zhejiang Cancer Hospital ( Site 0116)
- Hospital General de Medellin Luz Castro de Gutierrez ( Site 0368)
- Fundacion Centro de Investigacion Clinica CIC ( Site 0366)
- Biomelab S A S ( Site 0365)
- Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0374)
- Oncomedica S.A. ( Site 0372)
- Centro Medico Imbanaco de Cali S.A ( Site 0369)
- AS Ida-Tallinna Keskhaigla ( Site 0161)
- SA Pohja-Eesti Regionaalhaigla ( Site 0162)
- SA Tartu Ulikooli Kliinikum ( Site 0160)
- CHU Jean Minjoz ( Site 0167)
- Institut Curie - Centre Rene Huguenin ( Site 0181)
- ICM Val D Auerelle ( Site 0177)
- CHU de Grenoble - Hopital Michallon ( Site 0169)
- Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0185)
- Centre Hospitalier de la Cote Basque ( Site 0173)
- CHU de Rouen ( Site 0174)
- CHU Amiens Sud ( Site 0182)
- Centre hospitalier Toulon Sainte-Musse ( Site 0172)
- Institut Curie ( Site 0166)
- Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 0207)
- Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz ( Site 0202)
- CRU Hungary KFT ( Site 0209)
- Petz Aladar Megyei Oktato Korhaz ( Site 0213)
- Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0203)
- Tudogyogyintezet Torokbalint ( Site 0205)
- Semmelweis Egyetem ( Site 0210)
- Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 0217)
- Bnei Zion Medical Center ( Site 0227)
- Sheba Medical Center ( Site 0220)
- Soroka Medical Center ( Site 0222)
- Rambam Medical Center ( Site 0223)
- Meir Medical Center ( Site 0221)
- Rabin Medical Center ( Site 0224)
- Sourasky Medical Center ( Site 0225)
- Barzilai Medical Center ( Site 0226)
- Azienda Ospedaliera S. Giovanni Addolorata-Oncologia Medica ( Site 0233)
- Presidio Ospedaliero San Vincenzo ( Site 0231)
- Centro di Riferimento Oncologico CRO ( Site 0235)
- Azienda Ospedaliera San Giuseppe Moscati ( Site 0234)
- Universita Magna Grecia ( Site 0230)
- A.O. Universitaria Careggi ( Site 0236)
- Ospedale Santa Maria delle Croci ( Site 0232)
- Policlinico Gemelli di Roma ( Site 0237)
- Aichi Cancer Center Hospital ( Site 0018)
- Kurume University Hospital ( Site 0025)
- Hyogo Cancer Center ( Site 0021)
- Kanagawa Cardiovascular and Respiratory Center ( Site 0026)
- Kanagawa Cancer Center ( Site 0023)
- Miyagi Cancer Center ( Site 0028)
- Sendai Kousei Hospital ( Site 0022)
- Kindai University Hospital ( Site 0017)
- National Hospital Organization Kinki-chuo Chest Medical Center ( Site 0027)
- National Hospital Organization Kyushu Medical Center ( Site 0015)
- Kyushu University Hospital ( Site 0030)
- Okayama University Hospital ( Site 0020)
- Osaka International Cancer Institute ( Site 0019)
- Toranomon Hospital ( Site 0016)
- Juntendo University Hospital ( Site 0029)
- Nippon Medical School Hospital ( Site 0024)
- Chungbuk National University Hospital ( Site 0079)
- Seoul National University Bundang Hospital ( Site 0075)
- Ulsan University Hospital ( Site 0077)
- Asan Medical Center ( Site 0076)
- SMG-SNU Boramae Medical Center ( Site 0078)
- Hospital Tengku Ampuan Afzan ( Site 0062)
- Hospital Pulau Pinang. ( Site 0065)
- Sarawak General Hospital ( Site 0064)
- Beacon Hospital Sdn Bhd ( Site 0067)
- Institut Kanser Negara - National Cancer Institute ( Site 0063)
- University Malaya Medical Centre ( Site 0061)
- Gleneagles Penang ( Site 0066)
- Medica Sur S.A.B de C.V. ( Site 0384)
- Consultorios de Medicina Especializada del Sector Privado ( Site 0388)
- Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 0381)
- Instituto Nacional de Cancerologia. ( Site 0382)
- Oaxaca Site Management Organization SC ( Site 0389)
- SPZOZ USK nr 1 im. Norberta Barlickiego UM w Lodzi ( Site 0256)
- Szpital Uniwersytecki im. Karola Marcinkowskiego ( Site 0247)
- Krakowski Szpital Specjalistyczny im Jana Pawla II ( Site 0253)
- Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 0243)
- Centrum Medyczne Pratia Ostroleka ( Site 0242)
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0252)
- Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 0250)
- Ars Medical Sp. z o.o. ( Site 0254)
- Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 0262)
- Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0266)
- SBHI Samara Regional Clinical Oncology Dispensary ( Site 0265)
- SBHI Leningrad Regional Clinical Hospital ( Site 0263)
- Railway Hospital of OJSC ( Site 0268)
- City Clinical Oncology Center ( Site 0260)
- Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 0269)
- National Taiwan University Hospital Hsin-Chu Branch ( Site 0087)
- Taipei Medical University Shuang Ho Hospital ( Site 0090)
- National Cheng Kung University Hospital ( Site 0086)
- National Taiwan University Hospital ( Site 0088)
- Koo Foundation Sun Yat-Sen Cancer Center ( Site 0091)
- Taipei Veterans General Hospital ( Site 0089)
- Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 0321)
- Gulhane Egitim ve Arastirma Hastanesi ( Site 0316)
- Abdurrahman Yurtaslan Onkoloji Hastanesi ( Site 0318)
- Baskent Universitesi Ankara Hastanesi ( Site 0319)
- Antalya Memorial Hospital Department of Medical Oncology ( Site 0324)
- Akdeniz Universitesi Tip Fakultesi ( Site 0322)
- Dokuz Eylul Universitesi Arastirma Uygulama Hastanesi ( Site 0314)
- Sakarya Universitesi Egitim ve Arastirma Hastanesi ( Site 0323)
- Samsun Medical Park Hastanesi ( Site 0320)
- Cherkasy Regional Hospital ( Site 0336)
- City Clinical Hosp.4 of DCC ( Site 0338)
- MI Precarpathian Clinical Oncology Center ( Site 0346)
- Regional Centre of Oncology-Thoracic organs ( Site 0337)
- Ukranian Center of TomoTherapy ( Site 0344)
- Medical Center Verum ( Site 0334)
- Kyiv City Clinical Oncology Centre ( Site 0339)
- Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 0331)
- Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 0341)
- MI Odessa Regional Oncological Centre ( Site 0333)
- Podillya Regional Center of Oncology ( Site 0343)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pembrolizumab + Lenvatinib
Pembrolizumab + Placebo
Arm Description
Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity.
Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule QD on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity.
Outcomes
Primary Outcome Measures
Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
PFS was defined as the time from date of randomization to the date of the first documentation of progressive disease (PD) or death from any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. Data are from the product-limit (Kaplan-Meier) method for censored data. PFS as assessed by blinded independent central review (BICR) per RECIST 1.1 is presented.
Overall Survival (OS)
OS was defined as the time from date of randomization to date of death from any cause. OS is presented.
Secondary Outcome Measures
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
ORR was defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. ORR as assessed by BICR per RECIST 1.1 is presented.
Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be presented.
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
The number of participants who discontinue study treatment due to an AE will be presented.
Change From Baseline in Global Health Status (GHS) (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 [EORTC QLQ-C30] Item 29) 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. The change from baseline in GHS (EORTC QLQ-C30 Item 29) score will be presented. A higher score indicates a better overall GHS.
Change From Baseline in Quality of Life (QoL) (EORTC QLQ-C30 Item 30) 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 quality of life 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. The change from baseline in QoL (EORTC QLQ-C30 Item 30) score will be presented. A higher score indicates a better overall QoL.
Change From Baseline in Cough (EORTC Quality of Life Questionnaire-Lung Cancer Module 13 [QLQ-LC13] Item 31) Score
The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. 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. The change from baseline in cough (EORTC QLQ-LC13 Item 31) score will be presented. A lower score indicates a better outcome.
Change From Baseline in Chest Pain (EORTC QLQ-LC13 Item 40) Score
The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "Have you had pain in your chest?" 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. The change from baseline in chest pain (EORTC QLQ-LC13 Item 40) score will be presented. A lower score indicates a better outcome.
Change From Baseline in Dyspnea (EORTC QLQ-C30 Item 8) 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. The change from baseline in dyspnea (EORTC QLQ-C30 Item 8) score will be presented. A lower score indicates a better outcome.
Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) 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. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) score will be presented. A higher score indicates a better quality of life.
Time to True Deterioration (TTD) Based on Change From Baseline in Global Health Status (GHS) (EORTC QLQ-C30 Item 29) Score
TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in GHS (EORTC QLQ-C30 Item 29) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in GHS score, will be presented. A longer TTD indicates a better outcome.
Time to True Deterioration (TTD) Based on Change From Baseline in Quality of Life (QoL) (EORTC QLQ-C30 Item 30) Score
TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in QoL (EORTC QLQ-C30 Item 30) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in QoL score, will be presented. A longer TTD indicates a better outcome.
Time to True Deterioration (TTD) Based on Change From Baseline in the Composite Endpoint of Cough (EORTC QLQ-LC13 Item 31), Chest Pain (EORTC QLQ-LC13 Item 40), or Dyspnea (EORTC QLQ-C30 Item 8)
TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in the composite endpoint of cough (QLQ-LC13 item 31), chest pain (QLQ-LC13 item 40), or dyspnea (QLQ-C30 Item 8). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in the composite endpoint of cough, chest pain or dyspnea, will be presented. A longer TTD indicates a better outcome.
Time to True Deterioration (TTD) Based on Change From Baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Score
TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in physical functioning (EORTC QLQ-C30 Items 1-5) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in physical functioning score, will be presented.
Full Information
NCT ID
NCT03829332
First Posted
February 1, 2019
Last Updated
October 26, 2022
Sponsor
Merck Sharp & Dohme LLC
Collaborators
Eisai Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03829332
Brief Title
Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) in Adults With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Treatment-naïve Nonsmall Cell Lung Cancer (NSCLC) (MK-7902-007/E7080-G000-314/LEAP-007)
Official Title
A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) in Participants With Treatment-naïve, Metastatic Nonsmall Cell Lung Cancer (NSCLC) Whose Tumors Have a Tumor Proportion Score (TPS) Greater Than or Equal to 1% (LEAP-007)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 13, 2019 (Actual)
Primary Completion Date
May 19, 2021 (Actual)
Study Completion Date
March 8, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
Collaborators
Eisai Inc.
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 assess the safety and efficacy of pembrolizumab (MK-3475) combined with lenvatinib (MK-7902/E7080) compared to pembrolizumab alone (with placebo for lenvatinib) in treatment-naïve adults with no prior systemic therapy for their metastatic non-small cell lung cancer (NSCLC) whose tumors have a programmed cell death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) greater than or equal to 1%.
The primary study hypotheses are that: 1) the combination of pembrolizumab and lenvatinib is superior to pembrolizumab alone as assessed by Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1); and 2) the combination of pembrolizumab and lenvatinib is superior to pembrolizumab alone as assessed by Overall Survival (OS).
Detailed Description
As of 30-Jul-2021, active participants, investigator, and sponsor personnel or delegate(s) involved in the treatment administration or clinical evaluation of the participants will be unblinded. Participants will discontinue lenvatinib and placebo, and participants who remain on treatment will receive open-label pembrolizumab only.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
programmed cell death 1 (PD-1, PD1), programmed cell death-ligand 1 (PD-L1, PDL1), programmed cell death-ligand 2 (PD-L2, PDL2)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
623 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pembrolizumab + Lenvatinib
Arm Type
Experimental
Arm Description
Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity.
Arm Title
Pembrolizumab + Placebo
Arm Type
Active Comparator
Arm Description
Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule QD on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity.
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
MK-3475, KEYTRUDA®
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Lenvatinib
Other Intervention Name(s)
MK-7902, E7080, LENVIMA®
Intervention Description
oral capsule
Intervention Type
Drug
Intervention Name(s)
Placebo for lenvatinib
Intervention Description
oral capsule
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Description
PFS was defined as the time from date of randomization to the date of the first documentation of progressive disease (PD) or death from any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. Data are from the product-limit (Kaplan-Meier) method for censored data. PFS as assessed by blinded independent central review (BICR) per RECIST 1.1 is presented.
Time Frame
Up to approximately 25 months
Title
Overall Survival (OS)
Description
OS was defined as the time from date of randomization to date of death from any cause. OS is presented.
Time Frame
Up to approximately 25 months
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Description
ORR was defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. ORR as assessed by BICR per RECIST 1.1 is presented.
Time Frame
Up to approximately 25 months
Title
Number of Participants Who Experience an Adverse Event (AE)
Description
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be presented.
Time Frame
Through 90 days post last dose of study treatment (Up to approximately 27 months)
Title
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Description
The number of participants who discontinue study treatment due to an AE will be presented.
Time Frame
Through last dose of study treatment (Up to approximately 24 months)
Title
Change From Baseline in Global Health Status (GHS) (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 [EORTC QLQ-C30] Item 29) 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. The change from baseline in GHS (EORTC QLQ-C30 Item 29) score will be presented. A higher score indicates a better overall GHS.
Time Frame
Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)
Title
Change From Baseline in Quality of Life (QoL) (EORTC QLQ-C30 Item 30) 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 quality of life 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. The change from baseline in QoL (EORTC QLQ-C30 Item 30) score will be presented. A higher score indicates a better overall QoL.
Time Frame
Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)
Title
Change From Baseline in Cough (EORTC Quality of Life Questionnaire-Lung Cancer Module 13 [QLQ-LC13] Item 31) Score
Description
The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. 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. The change from baseline in cough (EORTC QLQ-LC13 Item 31) score will be presented. A lower score indicates a better outcome.
Time Frame
Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)
Title
Change From Baseline in Chest Pain (EORTC QLQ-LC13 Item 40) Score
Description
The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "Have you had pain in your chest?" 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. The change from baseline in chest pain (EORTC QLQ-LC13 Item 40) score will be presented. A lower score indicates a better outcome.
Time Frame
Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)
Title
Change From Baseline in Dyspnea (EORTC QLQ-C30 Item 8) 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. The change from baseline in dyspnea (EORTC QLQ-C30 Item 8) score will be presented. A lower score indicates a better outcome.
Time Frame
Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)
Title
Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) 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. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) score will be presented. A higher score indicates a better quality of life.
Time Frame
Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)
Title
Time to True Deterioration (TTD) Based on Change From Baseline in Global Health Status (GHS) (EORTC QLQ-C30 Item 29) Score
Description
TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in GHS (EORTC QLQ-C30 Item 29) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in GHS score, will be presented. A longer TTD indicates a better outcome.
Time Frame
Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)
Title
Time to True Deterioration (TTD) Based on Change From Baseline in Quality of Life (QoL) (EORTC QLQ-C30 Item 30) Score
Description
TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in QoL (EORTC QLQ-C30 Item 30) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in QoL score, will be presented. A longer TTD indicates a better outcome.
Time Frame
Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)
Title
Time to True Deterioration (TTD) Based on Change From Baseline in the Composite Endpoint of Cough (EORTC QLQ-LC13 Item 31), Chest Pain (EORTC QLQ-LC13 Item 40), or Dyspnea (EORTC QLQ-C30 Item 8)
Description
TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in the composite endpoint of cough (QLQ-LC13 item 31), chest pain (QLQ-LC13 item 40), or dyspnea (QLQ-C30 Item 8). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in the composite endpoint of cough, chest pain or dyspnea, will be presented. A longer TTD indicates a better outcome.
Time Frame
Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)
Title
Time to True Deterioration (TTD) Based on Change From Baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Score
Description
TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in physical functioning (EORTC QLQ-C30 Items 1-5) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in physical functioning score, will be presented.
Time Frame
Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Has a histologically or cytologically confirmed diagnosis of NSCLC.
Has Stage IV NSCLC (American Joint Committee on Cancer [AJCC 8th edition]).
Has measurable disease based on RECIST 1.1.
Has tumor tissue that demonstrates programmed cell death-ligand 1 (PD-L1) expression in ≥1% of tumor cells (Tumor Proportion Score [TPS] ≥1%) as assessed by immunohistochemistry (IHC) 22C3 pharmDx assay (Dako North America, Inc.) at a central laboratory.
Has a life expectancy of ≥3 months.
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose of study treatment but before randomization.
Male participants must agree to the following during the treatment period and for ≥7 days after the last dose of lenvatinib/matching placebo: 1) Be abstinent from heterosexual intercourse as their preferred and usual lifestyle and agree to remain abstinent, OR 2) Must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause).
Female participants are eligible to participate if not pregnant or breastfeeding, and ≥1 of the following applies: 1) Is not a woman of child-bearing potential (WOCBP), OR 2) Is a WOCBP and is using a highly effective contraceptive method that has a low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle during the treatment period and for ≥120 days post pembrolizumab or ≥30 days post lenvatinib/matching placebo, whichever occurs last.
Has adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤150/90 mm Hg and no change in antihypertensive medications within 1 week before randomization.
Has adequate organ function.
Exclusion Criteria:
Has known untreated central nervous system metastases and/or carcinomatous meningitis.
Has active hemoptysis (at least 0.5 teaspoon of bright red blood) within 2 weeks prior to the first dose of study intervention.
Has radiographic evidence of intratumoral cavitations, encasement, or invasion of a major blood vessel.
Has a known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for ≥3 years since initiation of that therapy. (Note: The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers.)
Has an active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
Has had an allogeneic tissue/solid organ transplant.
Has a known history of human immunodeficiency virus (HIV) infection.
Has a history of (noninfectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease.
Has a known history of hepatitis B or known active hepatitis C virus infection.
Has a history of a gastrointestinal condition or procedure that in the opinion of the investigator may affect oral study drug absorption.
Has significant cardiovascular impairment within 12 months of the first dose of study treatment, such as a history of congestive heart failure greater than New York Heart Association Class II, unstable angina, myocardial infarction, cerebrovascular accident/stroke, or cardiac arrhythmia associated with hemodynamic instability.
Has not recovered adequately from any toxicity and/or complications from major surgery before starting study treatment.
Has a known history of active tuberculosis (TB).
Has an active infection requiring systemic therapy.
Has previously had a severe hypersensitivity reaction to treatment with a monoclonal antibody or has a known sensitivity or intolerance to any component of lenvatinib or pembrolizumab.
Has received prior systemic chemotherapy or other targeted or biological antineoplastic therapy for their metastatic NSCLC.
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], Tumor necrosis factor receptor superfamily, member 4 [OX 40], tumor necrosis factor receptor superfamily member 9 [CD137]) or has received lenvatinib as monotherapy or in combination with anti- programmed cell death protein (anti-PD-1) agents.
Has received radiotherapy within 14 days before the first dose of study treatment or received lung radiation therapy of >30 Gray (Gy) within 6 months before the first dose of study treatment. (Note: Participants must have recovered from all radiation-related toxicities to ≤Grade 1, not require corticosteroids, and not have had radiation pneumonitis.)
Has a diagnosis of immunodeficiency or is receiving any form of immunosuppressive therapy within 7 days before the first dose of study treatment.
Is receiving systemic steroid therapy (doses >10 mg daily of prednisone equivalent) within 7 days before the first dose of study treatment.
Has received a live or attenuated vaccine within 30 days before the first dose of study treatment.
Has had major surgery within 3 weeks prior to first dose of study treatment
Has pre-existing ≥Grade 3 gastrointestinal or nongastrointestinal fistula.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Alaska Clinical Research Center ( Site 0511)
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99503
Country
United States
Facility Name
Ironwood Cancer & Research Centers ( Site 0541)
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
CBCC Global Research, Inc. ( Site 0532)
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Scripps Cancer Center ( Site 0521)
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Florida Hospital ( Site 0526)
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Northwest Georgia Oncology Centers PC ( Site 0518)
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Illinois Cancer Care, PC ( Site 0557)
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Parkview Cancer Center ( Site 0542)
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Facility Name
University of Kentucky School of Medicine & Hospitals ( Site 0517)
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Anne Arundel Medical Center Oncology and Hematology ( Site 0514)
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Munson Medical Center ( Site 0512)
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
Facility Name
Park Nicollet Frauenshuh Cancer Center ( Site 0554)
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55426
Country
United States
Facility Name
University of Missouri Health Care ( Site 0555)
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Billings Clinic Cancer Center ( Site 0508)
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Cone Health Cancer Center at Alamance Regional ( Site 0527)
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
Genesis Cancer Care Center ( Site 0559)
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
Country
United States
Facility Name
Oregon Health Sciences University ( Site 0544)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Central Texas Veterans Healthcare System ( Site 0533)
City
Temple
State/Province
Texas
ZIP/Postal Code
76504
Country
United States
Facility Name
Orange Health Services ( Site 0002)
City
Orange
State/Province
New South Wales
ZIP/Postal Code
2800
Country
Australia
Facility Name
Wollongong Private Hospital ( Site 0005)
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
The Prince Charles Hospital ( Site 0011)
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
Ballarat Oncology and Haematology Services ( Site 0008)
City
Wendouree
State/Province
Victoria
ZIP/Postal Code
3355
Country
Australia
Facility Name
St John of God Murdoch Medical Clinic ( Site 0001)
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Cross Cancer Institute ( Site 0400)
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Lions Gate Hospital ( Site 0407)
City
North Vancouver
State/Province
British Columbia
ZIP/Postal Code
V7L 2L7
Country
Canada
Facility Name
William Osler Health System (Brampton Civic Hospital) ( Site 0402)
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6R 3J7
Country
Canada
Facility Name
Windsor Regional Cancer Program ( Site 0404)
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 2X3
Country
Canada
Facility Name
McGill University Health Centre ( Site 0418)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Beijing Chest Hospital Capital Medical University ( Site 0111)
City
Beijing
State/Province
Anhui
ZIP/Postal Code
101149
Country
China
Facility Name
Anhui Provincial Hospital ( Site 0108)
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Facility Name
The First Affiliated Hospital of Anhui Medical University ( Site 0113)
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230088
Country
China
Facility Name
Peking Union Medical College Hospital ( Site 0105)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100006
Country
China
Facility Name
Beijing Cancer Hospital ( Site 0102)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100036
Country
China
Facility Name
Xiangya Hospital of Central South University ( Site 0115)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
Hunan Cancer Hospital ( Site 0104)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
Jiangsu Cancer Hospital ( Site 0101)
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Facility Name
The First Hospital of Jilin University ( Site 0110)
City
Chang chun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Zhongshan Hospital Fudan University ( Site 0100)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Shanghai Chest Hospital ( Site 0112)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
230000
Country
China
Facility Name
1st Affil Hosp of Med College of Xi'an Jiaotong University ( Site 0103)
City
XiAn
State/Province
Shanxi
ZIP/Postal Code
710061
Country
China
Facility Name
West China Hospital of Sichuan University ( Site 0117)
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
510115
Country
China
Facility Name
The First Affiliated Hospital Zhejiang University ( Site 0106)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
Hangzhou First People's Hospital ( Site 0109)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China
Facility Name
2nd Affil Hosp of Zhejiang University College of Medicine ( Site 0114)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Name
Zhejiang Cancer Hospital ( Site 0116)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
Hospital General de Medellin Luz Castro de Gutierrez ( Site 0368)
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
050015
Country
Colombia
Facility Name
Fundacion Centro de Investigacion Clinica CIC ( Site 0366)
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
050021
Country
Colombia
Facility Name
Biomelab S A S ( Site 0365)
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
080002
Country
Colombia
Facility Name
Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0374)
City
Valledupar
State/Province
Cesar
ZIP/Postal Code
200001
Country
Colombia
Facility Name
Oncomedica S.A. ( Site 0372)
City
Monteria
State/Province
Cordoba
ZIP/Postal Code
230002
Country
Colombia
Facility Name
Centro Medico Imbanaco de Cali S.A ( Site 0369)
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
760023
Country
Colombia
Facility Name
AS Ida-Tallinna Keskhaigla ( Site 0161)
City
Tallinn
State/Province
Harjumaa
ZIP/Postal Code
11312
Country
Estonia
Facility Name
SA Pohja-Eesti Regionaalhaigla ( Site 0162)
City
Tallin
State/Province
Harjumaa
ZIP/Postal Code
13419
Country
Estonia
Facility Name
SA Tartu Ulikooli Kliinikum ( Site 0160)
City
Tartu
State/Province
Tartumaa
ZIP/Postal Code
50406
Country
Estonia
Facility Name
CHU Jean Minjoz ( Site 0167)
City
Besancon
State/Province
Doubs
ZIP/Postal Code
25000
Country
France
Facility Name
Institut Curie - Centre Rene Huguenin ( Site 0181)
City
Saint-Cloud
State/Province
Hauts-de-Seine
ZIP/Postal Code
92210
Country
France
Facility Name
ICM Val D Auerelle ( Site 0177)
City
Montpellier
State/Province
Herault
ZIP/Postal Code
34090
Country
France
Facility Name
CHU de Grenoble - Hopital Michallon ( Site 0169)
City
La Tronche
State/Province
Isere
ZIP/Postal Code
38700
Country
France
Facility Name
Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0185)
City
Saint Herblain
State/Province
Loire-Atlantique
ZIP/Postal Code
44805
Country
France
Facility Name
Centre Hospitalier de la Cote Basque ( Site 0173)
City
Bayonne
State/Province
Pyrenees-Atlantiques
ZIP/Postal Code
64109
Country
France
Facility Name
CHU de Rouen ( Site 0174)
City
Rouen
State/Province
Seine-Maritime
ZIP/Postal Code
76000
Country
France
Facility Name
CHU Amiens Sud ( Site 0182)
City
Amiens
State/Province
Somme
ZIP/Postal Code
80054
Country
France
Facility Name
Centre hospitalier Toulon Sainte-Musse ( Site 0172)
City
Toulon
State/Province
Var
ZIP/Postal Code
83056
Country
France
Facility Name
Institut Curie ( Site 0166)
City
Paris
ZIP/Postal Code
75248
Country
France
Facility Name
Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 0207)
City
Gyula
State/Province
Bekes
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz ( Site 0202)
City
Miskolc
State/Province
Borsod-Abauj-Zemplen
ZIP/Postal Code
3529
Country
Hungary
Facility Name
CRU Hungary KFT ( Site 0209)
City
Miskolc
State/Province
Borsod-Abauj-Zemplen
ZIP/Postal Code
3529
Country
Hungary
Facility Name
Petz Aladar Megyei Oktato Korhaz ( Site 0213)
City
Gyor
State/Province
Gyor-Moson-Sopron
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0203)
City
Szolnok
State/Province
Jasz-Nagykun-Szolnok
ZIP/Postal Code
5000
Country
Hungary
Facility Name
Tudogyogyintezet Torokbalint ( Site 0205)
City
Torokbalint
State/Province
Pest
ZIP/Postal Code
2045
Country
Hungary
Facility Name
Semmelweis Egyetem ( Site 0210)
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 0217)
City
Kaposvar
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Bnei Zion Medical Center ( Site 0227)
City
Haifa
State/Province
Heifa
ZIP/Postal Code
3339419
Country
Israel
Facility Name
Sheba Medical Center ( Site 0220)
City
Ramat Gan
State/Province
Tel Aviv
ZIP/Postal Code
5266202
Country
Israel
Facility Name
Soroka Medical Center ( Site 0222)
City
Beer Sheva
ZIP/Postal Code
8457108
Country
Israel
Facility Name
Rambam Medical Center ( Site 0223)
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Meir Medical Center ( Site 0221)
City
Kfar-Saba
ZIP/Postal Code
4428132
Country
Israel
Facility Name
Rabin Medical Center ( Site 0224)
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Sourasky Medical Center ( Site 0225)
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Barzilai Medical Center ( Site 0226)
City
Ashkelon
State/Province
Ḥeifā
ZIP/Postal Code
7830604
Country
Israel
Facility Name
Azienda Ospedaliera S. Giovanni Addolorata-Oncologia Medica ( Site 0233)
City
Roma
State/Province
Lazio
ZIP/Postal Code
00185
Country
Italy
Facility Name
Presidio Ospedaliero San Vincenzo ( Site 0231)
City
Taormina
State/Province
Messina
ZIP/Postal Code
98039
Country
Italy
Facility Name
Centro di Riferimento Oncologico CRO ( Site 0235)
City
Aviano
State/Province
Pordenone
ZIP/Postal Code
33081
Country
Italy
Facility Name
Azienda Ospedaliera San Giuseppe Moscati ( Site 0234)
City
Avellino
ZIP/Postal Code
83100
Country
Italy
Facility Name
Universita Magna Grecia ( Site 0230)
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
A.O. Universitaria Careggi ( Site 0236)
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Ospedale Santa Maria delle Croci ( Site 0232)
City
Ravenna
ZIP/Postal Code
48121
Country
Italy
Facility Name
Policlinico Gemelli di Roma ( Site 0237)
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Aichi Cancer Center Hospital ( Site 0018)
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Kurume University Hospital ( Site 0025)
City
Kurume
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Hyogo Cancer Center ( Site 0021)
City
Akashi
State/Province
Hyogo
ZIP/Postal Code
673-8558
Country
Japan
Facility Name
Kanagawa Cardiovascular and Respiratory Center ( Site 0026)
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
236-0051
Country
Japan
Facility Name
Kanagawa Cancer Center ( Site 0023)
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Facility Name
Miyagi Cancer Center ( Site 0028)
City
Natori
State/Province
Miyagi
ZIP/Postal Code
981-1293
Country
Japan
Facility Name
Sendai Kousei Hospital ( Site 0022)
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
980-0873
Country
Japan
Facility Name
Kindai University Hospital ( Site 0017)
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
National Hospital Organization Kinki-chuo Chest Medical Center ( Site 0027)
City
Sakai
State/Province
Osaka
ZIP/Postal Code
591-8555
Country
Japan
Facility Name
National Hospital Organization Kyushu Medical Center ( Site 0015)
City
Fukuoka
ZIP/Postal Code
810-8563
Country
Japan
Facility Name
Kyushu University Hospital ( Site 0030)
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Okayama University Hospital ( Site 0020)
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Osaka International Cancer Institute ( Site 0019)
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Facility Name
Toranomon Hospital ( Site 0016)
City
Tokyo
ZIP/Postal Code
105-8470
Country
Japan
Facility Name
Juntendo University Hospital ( Site 0029)
City
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
Nippon Medical School Hospital ( Site 0024)
City
Tokyo
ZIP/Postal Code
113-8603
Country
Japan
Facility Name
Chungbuk National University Hospital ( Site 0079)
City
Cheongju si
State/Province
Chungbuk
ZIP/Postal Code
28644
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital ( Site 0075)
City
Seongnam-si
State/Province
Kyonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Ulsan University Hospital ( Site 0077)
City
Ulsan
State/Province
Ulsan-Kwangyokshi
ZIP/Postal Code
44033
Country
Korea, Republic of
Facility Name
Asan Medical Center ( Site 0076)
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
SMG-SNU Boramae Medical Center ( Site 0078)
City
Seoul
ZIP/Postal Code
07061
Country
Korea, Republic of
Facility Name
Hospital Tengku Ampuan Afzan ( Site 0062)
City
Kuantan
State/Province
Pahang
ZIP/Postal Code
25100
Country
Malaysia
Facility Name
Hospital Pulau Pinang. ( Site 0065)
City
Georgetown
State/Province
Pulau Pinang
ZIP/Postal Code
10990
Country
Malaysia
Facility Name
Sarawak General Hospital ( Site 0064)
City
Kuching
State/Province
Sarawak
ZIP/Postal Code
93586
Country
Malaysia
Facility Name
Beacon Hospital Sdn Bhd ( Site 0067)
City
Petaling Jaya
State/Province
Selangor
ZIP/Postal Code
46050
Country
Malaysia
Facility Name
Institut Kanser Negara - National Cancer Institute ( Site 0063)
City
Putrajaya
State/Province
Wilayah Persekutuan Putrajaya
ZIP/Postal Code
62250
Country
Malaysia
Facility Name
University Malaya Medical Centre ( Site 0061)
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Gleneagles Penang ( Site 0066)
City
Pulau Pinang
ZIP/Postal Code
10050
Country
Malaysia
Facility Name
Medica Sur S.A.B de C.V. ( Site 0384)
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
14050
Country
Mexico
Facility Name
Consultorios de Medicina Especializada del Sector Privado ( Site 0388)
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44680
Country
Mexico
Facility Name
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 0381)
City
Madero
State/Province
Tamaulipas
ZIP/Postal Code
89440
Country
Mexico
Facility Name
Instituto Nacional de Cancerologia. ( Site 0382)
City
Mexico City
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Oaxaca Site Management Organization SC ( Site 0389)
City
Oaxaca
ZIP/Postal Code
68000
Country
Mexico
Facility Name
SPZOZ USK nr 1 im. Norberta Barlickiego UM w Lodzi ( Site 0256)
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
99-153
Country
Poland
Facility Name
Szpital Uniwersytecki im. Karola Marcinkowskiego ( Site 0247)
City
Zielona Gora
State/Province
Lubuskie
ZIP/Postal Code
65-046
Country
Poland
Facility Name
Krakowski Szpital Specjalistyczny im Jana Pawla II ( Site 0253)
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-202
Country
Poland
Facility Name
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 0243)
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-826
Country
Poland
Facility Name
Centrum Medyczne Pratia Ostroleka ( Site 0242)
City
Ostroleka
State/Province
Mazowieckie
ZIP/Postal Code
07-410
Country
Poland
Facility Name
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0252)
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 0250)
City
Przemysl
State/Province
Podkarpackie
ZIP/Postal Code
37-700
Country
Poland
Facility Name
Ars Medical Sp. z o.o. ( Site 0254)
City
Pila
State/Province
Wielkopolskie
ZIP/Postal Code
64-920
Country
Poland
Facility Name
Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 0262)
City
Ufa
State/Province
Baskortostan, Respublika
ZIP/Postal Code
450054
Country
Russian Federation
Facility Name
Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0266)
City
Krasnoyarsk
State/Province
Krasnoyarskiy Kray
ZIP/Postal Code
660133
Country
Russian Federation
Facility Name
SBHI Samara Regional Clinical Oncology Dispensary ( Site 0265)
City
Samara
State/Province
Samarskaya Oblast
ZIP/Postal Code
443031
Country
Russian Federation
Facility Name
SBHI Leningrad Regional Clinical Hospital ( Site 0263)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
Railway Hospital of OJSC ( Site 0268)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
195271
Country
Russian Federation
Facility Name
City Clinical Oncology Center ( Site 0260)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 0269)
City
Kazan
State/Province
Tatarstan, Respublika
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
National Taiwan University Hospital Hsin-Chu Branch ( Site 0087)
City
Hsinchu
ZIP/Postal Code
300
Country
Taiwan
Facility Name
Taipei Medical University Shuang Ho Hospital ( Site 0090)
City
New Taipei
ZIP/Postal Code
235
Country
Taiwan
Facility Name
National Cheng Kung University Hospital ( Site 0086)
City
Tainan
ZIP/Postal Code
70457
Country
Taiwan
Facility Name
National Taiwan University Hospital ( Site 0088)
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Koo Foundation Sun Yat-Sen Cancer Center ( Site 0091)
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Taipei Veterans General Hospital ( Site 0089)
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 0321)
City
Konya
State/Province
Adana
ZIP/Postal Code
42080
Country
Turkey
Facility Name
Gulhane Egitim ve Arastirma Hastanesi ( Site 0316)
City
Ankara
ZIP/Postal Code
06010
Country
Turkey
Facility Name
Abdurrahman Yurtaslan Onkoloji Hastanesi ( Site 0318)
City
Ankara
ZIP/Postal Code
06200
Country
Turkey
Facility Name
Baskent Universitesi Ankara Hastanesi ( Site 0319)
City
Ankara
ZIP/Postal Code
06490
Country
Turkey
Facility Name
Antalya Memorial Hospital Department of Medical Oncology ( Site 0324)
City
Antalya
ZIP/Postal Code
07020
Country
Turkey
Facility Name
Akdeniz Universitesi Tip Fakultesi ( Site 0322)
City
Antalya
ZIP/Postal Code
07070
Country
Turkey
Facility Name
Dokuz Eylul Universitesi Arastirma Uygulama Hastanesi ( Site 0314)
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Sakarya Universitesi Egitim ve Arastirma Hastanesi ( Site 0323)
City
Sakarya
ZIP/Postal Code
54290
Country
Turkey
Facility Name
Samsun Medical Park Hastanesi ( Site 0320)
City
Samsun
ZIP/Postal Code
55200
Country
Turkey
Facility Name
Cherkasy Regional Hospital ( Site 0336)
City
Cherkasy
State/Province
Cherkaska Oblast
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
City Clinical Hosp.4 of DCC ( Site 0338)
City
Dnipro
State/Province
Dnipropetrovska Oblast
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
MI Precarpathian Clinical Oncology Center ( Site 0346)
City
Ivano-Frankivsk
State/Province
Ivano-Frankivska Oblast
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Regional Centre of Oncology-Thoracic organs ( Site 0337)
City
Kharkiv
State/Province
Kharkivska Oblast
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
Ukranian Center of TomoTherapy ( Site 0344)
City
Kropyvnytskiy
State/Province
Kirovohradska Oblast
ZIP/Postal Code
25011
Country
Ukraine
Facility Name
Medical Center Verum ( Site 0334)
City
Kyiv
State/Province
Kyivska Oblast
ZIP/Postal Code
03039
Country
Ukraine
Facility Name
Kyiv City Clinical Oncology Centre ( Site 0339)
City
Kyiv
State/Province
Kyivska Oblast
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 0331)
City
Kyiv
State/Province
Kyivska Oblast
ZIP/Postal Code
03126
Country
Ukraine
Facility Name
Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 0341)
City
Lviv
State/Province
Lvivska Oblast
ZIP/Postal Code
79031
Country
Ukraine
Facility Name
MI Odessa Regional Oncological Centre ( Site 0333)
City
Odesa
State/Province
Odeska Oblast
ZIP/Postal Code
65055
Country
Ukraine
Facility Name
Podillya Regional Center of Oncology ( Site 0343)
City
Vinnytsia
State/Province
Vinnytska Oblast
ZIP/Postal Code
21029
Country
Ukraine
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
33300372
Citation
Taylor MH, Schmidt EV, Dutcus C, Pinheiro EM, Funahashi Y, Lubiniecki G, Rasco D. The LEAP program: lenvatinib plus pembrolizumab for the treatment of advanced solid tumors. Future Oncol. 2021 Feb;17(6):637-648. doi: 10.2217/fon-2020-0937. Epub 2020 Dec 10.
Results Reference
derived
Links:
URL
http://merckoncologyclinicaltrials.com
Description
Merck Oncology Clinical Trial Information
Learn more about this trial
Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) in Adults With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Treatment-naïve Nonsmall Cell Lung Cancer (NSCLC) (MK-7902-007/E7080-G000-314/LEAP-007)
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