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)
NCT ID: NCT03829332
Last Updated: 2025-04-16
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
623 participants
INTERVENTIONAL
2019-03-13
2024-04-24
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety of Pembrolizumab (MK-3475) With Lenvatinib (E7080/MK-7902) vs. Docetaxel in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) and Progressive Disease (PD) After Platinum Doublet Chemotherapy and Immunotherapy (MK-7902-008/E7080-G000-316/LEAP-008)
NCT03976375
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] - China Extension Study
NCT04676412
Safety and Efficacy Study of Pemetrexed + Platinum Chemotherapy + Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-7902-006/E7080-G000-315/LEAP-006)
NCT03829319
Study of Pembrolizumab (MK-3475) Versus Platinum-Based Chemotherapy for Participants With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Advanced or Metastatic Non-Small Cell Lung Cancer (MK-3475-042/KEYNOTE-042)
NCT02220894
Study of Pembrolizumab Versus Docetaxel in Participants Previously Treated for Non-Small Cell Lung Cancer (MK-3475-033/KEYNOTE-033)
NCT02864394
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Pembrolizumab + Lenvatinib
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.
Pembrolizumab
IV infusion
Lenvatinib
oral capsule
Pembrolizumab + Placebo
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.
Pembrolizumab
IV infusion
Placebo for lenvatinib
oral capsule
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pembrolizumab
IV infusion
Lenvatinib
oral capsule
Placebo for lenvatinib
oral capsule
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Eisai Inc.
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Alaska Clinical Research Center ( Site 0511)
Anchorage, Alaska, United States
Ironwood Cancer & Research Centers ( Site 0541)
Chandler, Arizona, United States
CBCC Global Research, Inc. ( Site 0532)
Bakersfield, California, United States
Scripps Cancer Center ( Site 0521)
La Jolla, California, United States
Florida Hospital ( Site 0526)
Orlando, Florida, United States
Northwest Georgia Oncology Centers PC ( Site 0518)
Marietta, Georgia, United States
Illinois Cancer Care, PC ( Site 0557)
Peoria, Illinois, United States
Parkview Cancer Center ( Site 0542)
Fort Wayne, Indiana, United States
University of Kentucky School of Medicine & Hospitals ( Site 0517)
Lexington, Kentucky, United States
Anne Arundel Medical Center Oncology and Hematology ( Site 0514)
Annapolis, Maryland, United States
Munson Medical Center ( Site 0512)
Traverse City, Michigan, United States
Park Nicollet Frauenshuh Cancer Center ( Site 0554)
Saint Louis Park, Minnesota, United States
University of Missouri Health Care ( Site 0555)
Columbia, Missouri, United States
Billings Clinic Cancer Center ( Site 0508)
Billings, Montana, United States
Cone Health Cancer Center at Alamance Regional ( Site 0527)
Greensboro, North Carolina, United States
Genesis Cancer Care Center ( Site 0559)
Zanesville, Ohio, United States
Oregon Health Sciences University ( Site 0544)
Portland, Oregon, United States
Central Texas Veterans Healthcare System ( Site 0533)
Temple, Texas, United States
Orange Health Services ( Site 0002)
Orange, New South Wales, Australia
Wollongong Private Hospital ( Site 0005)
Wollongong, New South Wales, Australia
The Prince Charles Hospital ( Site 0011)
Chermside, Queensland, Australia
Ballarat Oncology and Haematology Services ( Site 0008)
Wendouree, Victoria, Australia
St John of God Murdoch Medical Clinic ( Site 0001)
Perth, Western Australia, Australia
Cross Cancer Institute ( Site 0400)
Edmonton, Alberta, Canada
Lions Gate Hospital ( Site 0407)
North Vancouver, British Columbia, Canada
William Osler Health System (Brampton Civic Hospital) ( Site 0402)
Brampton, Ontario, Canada
Windsor Regional Cancer Program ( Site 0404)
Windsor, Ontario, Canada
McGill University Health Centre ( Site 0418)
Montreal, Quebec, Canada
Beijing Chest Hospital Capital Medical University ( Site 0111)
Beijing, Anhui, China
Anhui Provincial Hospital ( Site 0108)
Hefei, Anhui, China
The First Affiliated Hospital of Anhui Medical University ( Site 0113)
Hefei, Anhui, China
Peking Union Medical College Hospital ( Site 0105)
Beijing, Beijing Municipality, China
Beijing Cancer Hospital ( Site 0102)
Beijing, Beijing Municipality, China
Xiangya Hospital of Central South University ( Site 0115)
Changsha, Hunan, China
Hunan Cancer Hospital ( Site 0104)
Changsha, Hunan, China
Jiangsu Cancer Hospital ( Site 0101)
Nanjing, Jiangsu, China
The First Hospital of Jilin University ( Site 0110)
Changchun, Jilin, China
Zhongshan Hospital Fudan University ( Site 0100)
Shanghai, Shanghai Municipality, China
Shanghai Chest Hospital ( Site 0112)
Shanghai, Shanghai Municipality, China
1st Affil Hosp of Med College of Xi'an Jiaotong University ( Site 0103)
XiAn, Shanxi, China
West China Hospital of Sichuan University ( Site 0117)
Chengdu, Sichuan, China
The First Affiliated Hospital Zhejiang University ( Site 0106)
Hangzhou, Zhejiang, China
Hangzhou First People's Hospital ( Site 0109)
Hangzhou, Zhejiang, China
2nd Affil Hosp of Zhejiang University College of Medicine ( Site 0114)
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital ( Site 0116)
Hangzhou, Zhejiang, China
Hospital General de Medellin Luz Castro de Gutierrez ( Site 0368)
Medellín, Antioquia, Colombia
Fundacion Centro de Investigacion Clinica CIC ( Site 0366)
Medellín, Antioquia, Colombia
Biomelab S A S ( Site 0365)
Barranquilla, Atlántico, Colombia
Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0374)
Valledupar, Cesar Department, Colombia
Oncomedica S.A. ( Site 0372)
Montería, Departamento de Córdoba, Colombia
Centro Medico Imbanaco de Cali S.A ( Site 0369)
Cali, Valle del Cauca Department, Colombia
AS Ida-Tallinna Keskhaigla ( Site 0161)
Tallinn, Harju, Estonia
SA Pohja-Eesti Regionaalhaigla ( Site 0162)
Tallinn, Harju, Estonia
SA Tartu Ulikooli Kliinikum ( Site 0160)
Tartu, Tartu, Estonia
CHU Jean Minjoz ( Site 0167)
Besançon, Doubs, France
Institut Curie - Centre Rene Huguenin ( Site 0181)
Saint-Cloud, Hauts-de-Seine, France
ICM Val D Auerelle ( Site 0177)
Montpellier, Herault, France
CHU de Grenoble - Hopital Michallon ( Site 0169)
La Tronche, Isere, France
Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0185)
Saint-Herblain, Loire-Atlantique, France
Centre Hospitalier de la Cote Basque ( Site 0173)
Bayonne, Pyrenees-Atlantiques, France
CHU de Rouen ( Site 0174)
Rouen, Seine-Maritime, France
CHU Amiens Sud ( Site 0182)
Amiens, Somme, France
Centre hospitalier Toulon Sainte-Musse ( Site 0172)
Toulon, Var, France
Institut Curie ( Site 0166)
Paris, , France
Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 0207)
Gyula, Bekes County, Hungary
Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz ( Site 0202)
Miskolc, Borsod-Abauj Zemplen county, Hungary
CRU Hungary KFT ( Site 0209)
Miskolc, Borsod-Abauj Zemplen county, Hungary
Petz Aladar Megyei Oktato Korhaz ( Site 0213)
Győr, Győr-Moson-Sopron, Hungary
Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0203)
Szolnok, Jász-Nagykun-Szolnok, Hungary
Tudogyogyintezet Torokbalint ( Site 0205)
Törökbálint, Pest County, Hungary
Semmelweis Egyetem ( Site 0210)
Budapest, , Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 0217)
Kaposvár, , Hungary
Bnei Zion Medical Center ( Site 0227)
Haifa, Heifa, Israel
Sheba Medical Center ( Site 0220)
Ramat Gan, Tel Aviv, Israel
Soroka Medical Center ( Site 0222)
Beersheba, , Israel
Rambam Medical Center ( Site 0223)
Haifa, , Israel
Meir Medical Center ( Site 0221)
Kfar Saba, , Israel
Rabin Medical Center ( Site 0224)
Petah Tikva, , Israel
Sourasky Medical Center ( Site 0225)
Tel Aviv, , Israel
Barzilai Medical Center ( Site 0226)
Ashkelon, Ḥeifā, Israel
Azienda Ospedaliera S. Giovanni Addolorata-Oncologia Medica ( Site 0233)
Rome, Lazio, Italy
Presidio Ospedaliero San Vincenzo ( Site 0231)
Taormina, Messina, Italy
Centro di Riferimento Oncologico CRO ( Site 0235)
Aviano, Pordenone, Italy
Azienda Ospedaliera San Giuseppe Moscati ( Site 0234)
Avellino, , Italy
Universita Magna Grecia ( Site 0230)
Catanzaro, , Italy
A.O. Universitaria Careggi ( Site 0236)
Florence, , Italy
Ospedale Santa Maria delle Croci ( Site 0232)
Ravenna, , Italy
Policlinico Gemelli di Roma ( Site 0237)
Roma, , Italy
Aichi Cancer Center Hospital ( Site 0018)
Nagoya, Aichi-ken, Japan
Kurume University Hospital ( Site 0025)
Kurume, Fukuoka, Japan
Hyogo Cancer Center ( Site 0021)
Akashi, Hyōgo, Japan
Kanagawa Cardiovascular and Respiratory Center ( Site 0026)
Yokohama, Kanagawa, Japan
Kanagawa Cancer Center ( Site 0023)
Yokohama, Kanagawa, Japan
Miyagi Cancer Center ( Site 0028)
Natori-shi, Miyagi, Japan
Sendai Kousei Hospital ( Site 0022)
Sendai, Miyagi, Japan
National Hospital Organization Kinki-chuo Chest Medical Center ( Site 0027)
Sakai, Osaka, Japan
Kindai University Hospital ( Site 0017)
Sayama, Osaka, Japan
National Hospital Organization Kyushu Medical Center ( Site 0015)
Fukuoka, , Japan
Kyushu University Hospital ( Site 0030)
Fukuoka, , Japan
Okayama University Hospital ( Site 0020)
Okayama, , Japan
Osaka International Cancer Institute ( Site 0019)
Osaka, , Japan
Toranomon Hospital ( Site 0016)
Tokyo, , Japan
Juntendo University Hospital ( Site 0029)
Tokyo, , Japan
Nippon Medical School Hospital ( Site 0024)
Tokyo, , Japan
Hospital Tengku Ampuan Afzan ( Site 0062)
Kuantan, Pahang, Malaysia
Hospital Pulau Pinang. ( Site 0065)
George Town, Pulau Pinang, Malaysia
Institut Kanser Negara - National Cancer Institute ( Site 0063)
Putrajaya, Putrajaya, Malaysia
Sarawak General Hospital ( Site 0064)
Kuching, Sarawak, Malaysia
Beacon Hospital Sdn Bhd ( Site 0067)
Petaling Jaya, Selangor, Malaysia
University Malaya Medical Centre ( Site 0061)
Kuala Lumpur, , Malaysia
Gleneagles Penang ( Site 0066)
Pulau Pinang, , Malaysia
Consultorios de Medicina Especializada del Sector Privado ( Site 0388)
Guadalajara, Jalisco, Mexico
Medica Sur S.A.B de C.V. ( Site 0384)
Mexico City, Mexico City, Mexico
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 0381)
Madero, Tamaulipas, Mexico
Instituto Nacional de Cancerologia. ( Site 0382)
Mexico City, , Mexico
Oaxaca Site Management Organization SC ( Site 0389)
Oaxaca City, , Mexico
Ars Medical Sp. z o.o. ( Site 0254)
Piła, Greater Poland Voivodeship, Poland
Krakowski Szpital Specjalistyczny im Jana Pawla II ( Site 0253)
Krakow, Lesser Poland Voivodeship, Poland
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 0243)
Krakow, Lesser Poland Voivodeship, Poland
Szpital Uniwersytecki im. Karola Marcinkowskiego ( Site 0247)
Zielona Góra, Lubusz Voivodeship, Poland
Centrum Medyczne Pratia Ostroleka ( Site 0242)
Ostrołęka, Masovian Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0252)
Warsaw, Masovian Voivodeship, Poland
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 0250)
Przemyśl, Podkarpackie Voivodeship, Poland
SPZOZ USK nr 1 im. Norberta Barlickiego UM w Lodzi ( Site 0256)
Lodz, Łódź Voivodeship, Poland
Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 0262)
Ufa, Baskortostan, Respublika, Russia
Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0266)
Krasnoyarsk, Krasnoyarsk Krai, Russia
SBHI Samara Regional Clinical Oncology Dispensary ( Site 0265)
Samara, Samara Oblast, Russia
SBHI Leningrad Regional Clinical Hospital ( Site 0263)
Saint Petersburg, Sankt-Peterburg, Russia
Railway Hospital of OJSC ( Site 0268)
Saint Petersburg, Sankt-Peterburg, Russia
City Clinical Oncology Center ( Site 0260)
Saint Petersburg, Sankt-Peterburg, Russia
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 0269)
Kazan', Tatarstan, Respublika, Russia
Seoul National University Bundang Hospital ( Site 0075)
Seongnam-si, Kyonggi-do, South Korea
Chungbuk National University Hospital ( Site 0079)
Cheongju-si, North Chungcheong, South Korea
Ulsan University Hospital ( Site 0077)
Ulsan, Ulsan-Kwangyokshi, South Korea
Asan Medical Center ( Site 0076)
Seoul, , South Korea
SMG-SNU Boramae Medical Center ( Site 0078)
Seoul, , South Korea
National Taiwan University Hospital Hsin-Chu Branch ( Site 0087)
Hsinchu, , Taiwan
Taipei Medical University Shuang Ho Hospital ( Site 0090)
New Taipei City, , Taiwan
National Cheng Kung University Hospital ( Site 0086)
Tainan City, , Taiwan
National Taiwan University Hospital ( Site 0088)
Taipei, , Taiwan
Koo Foundation Sun Yat-Sen Cancer Center ( Site 0091)
Taipei, , Taiwan
Taipei Veterans General Hospital ( Site 0089)
Taipei, , Taiwan
Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 0321)
Konya, Adana, Turkey (Türkiye)
Gulhane Egitim ve Arastirma Hastanesi ( Site 0316)
Ankara, , Turkey (Türkiye)
Abdurrahman Yurtaslan Onkoloji Hastanesi ( Site 0318)
Ankara, , Turkey (Türkiye)
Baskent Universitesi Ankara Hastanesi ( Site 0319)
Ankara, , Turkey (Türkiye)
Antalya Memorial Hospital Department of Medical Oncology ( Site 0324)
Antalya, , Turkey (Türkiye)
Akdeniz Universitesi Tip Fakultesi ( Site 0322)
Antalya, , Turkey (Türkiye)
Dokuz Eylul Universitesi Arastirma Uygulama Hastanesi ( Site 0314)
Izmir, , Turkey (Türkiye)
Sakarya Universitesi Egitim ve Arastirma Hastanesi ( Site 0323)
Sakarya, , Turkey (Türkiye)
Samsun Medical Park Hastanesi ( Site 0320)
Samsun, , Turkey (Türkiye)
Cherkasy Regional Hospital ( Site 0336)
Cherkasy, Cherkasy Oblast, Ukraine
City Clinical Hosp.4 of DCC ( Site 0338)
Dnipro, Dnipropetrovsk Oblast, Ukraine
MI Precarpathian Clinical Oncology Center ( Site 0346)
Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine
Regional Centre of Oncology-Thoracic organs ( Site 0337)
Kharkiv, Kharkivs’ka Oblast’, Ukraine
Ukranian Center of TomoTherapy ( Site 0344)
Kropyvnytskiy, Kirovohrad Oblast, Ukraine
Medical Center Verum ( Site 0334)
Kyiv, Kyivska Oblast, Ukraine
Kyiv City Clinical Oncology Centre ( Site 0339)
Kyiv, Kyivska Oblast, Ukraine
Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 0331)
Kyiv, Kyivska Oblast, Ukraine
Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 0341)
Lviv, Lviv Oblast, Ukraine
MI Odessa Regional Oncological Centre ( Site 0333)
Odesa, Odesa Oblast, Ukraine
Podillya Regional Center of Oncology ( Site 0343)
Vinnytsia, Vinnytsia Oblast, Ukraine
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Yang JC, Han B, De La Mora Jimenez E, Lee JS, Koralewski P, Karadurmus N, Sugawara S, Livi L, Basappa NS, Quantin X, Dudnik J, Ortiz DM, Mekhail T, Okpara CE, Dutcus C, Zimmer Z, Samkari A, Bhagwati N, Csoszi T. Pembrolizumab With or Without Lenvatinib for First-Line Metastatic NSCLC With Programmed Cell Death-Ligand 1 Tumor Proportion Score of at least 1% (LEAP-007): A Randomized, Double-Blind, Phase 3 Trial. J Thorac Oncol. 2024 Jun;19(6):941-953. doi: 10.1016/j.jtho.2023.12.023. Epub 2023 Dec 29.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Merck Clinical Trial Information
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MK-7902-007
Identifier Type: OTHER
Identifier Source: secondary_id
E7080-G000-314
Identifier Type: OTHER
Identifier Source: secondary_id
LEAP-007
Identifier Type: OTHER
Identifier Source: secondary_id
194670
Identifier Type: REGISTRY
Identifier Source: secondary_id
2018-003794-98
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
7902-007
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.