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)
A Phase 3 Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Pemetrexed + Platinum Chemotherapy + Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First-line Intervention in Participants With Metastatic Nonsquamous Non-small Cell Lung Cancer (LEAP-006)
6 other identifiers
interventional
761
17 countries
158
Brief Summary
The purpose of this study is to assess the safety and efficacy 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. The primary study hypotheses state that: 1) the combination of lenvatinib + platinum doublet chemotherapy + pembrolizumab prolongs Progression-free Survival (PFS) as assessed by blinded independent central review (BICR) per modified Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST 1.1) compared to matching placebo + platinum doublet chemotherapy + pembrolizumab, and 2) the combination of lenvatinib + platinum doublet chemotherapy + pembrolizumab prolongs Overall Survival (OS) compared to matching placebo + platinum doublet chemotherapy + pembrolizumab.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2019
Longer than P75 for phase_3
158 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2019
CompletedFirst Posted
Study publicly available on registry
February 4, 2019
CompletedStudy Start
First participant enrolled
March 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 11, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2024
CompletedResults Posted
Study results publicly available
February 21, 2025
CompletedFebruary 5, 2026
December 1, 2025
4.4 years
February 1, 2019
August 9, 2024
January 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Part 1: Number of Participants With a Dose-limiting Toxicity (DLT)
Dose-limiting toxicity using Common Terminology Criteria for Adverse Events v4.0 for grading, is defined as any of the following hematologic toxicities: 1) Grade 4 neutropenia, 2) Grade 3 or 4 febrile neutropenia, 3) thrombocytopenia \<25,000 cells/mm\^3 associated with bleeding and/or which requires platelet transfusion, or any of the following non-hematologic toxicities: 4) any other Grade 4 or 5 toxicity, 5) Grade 3 toxicities lasting \>3 days (exclusions apply), 6) Grade 3 hypertension not controlled by medication, 7) Grade 3 or above gastrointestinal perforation, 8) Grade 3 or above wound dehiscence requiring medical or surgical intervention, 9) any grade thromboembolic event, or 10) any Grade 3 nonhematologic laboratory value if medical intervention is required or the abnormality leads to hospitalization.
Cycle 1; each cycle is 21 days (up to 21 days)
Part 1: Number of Participants Who Experienced an Adverse Event (AE)
An adverse event is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience one of more adverse events during Part 1 of this study will be presented.
Up to approximately 48 months
Part 1: Number of Participants Who Discontinued Study Drug Due to an Adverse Event
An adverse event is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study medication due to and adverse event during Part 1 of this study will be presented.
Up to approximately 58 months
Part 2: Progression-free Survival (PFS) Per 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.
Up to approximately 36 months
Part 2: Overall Survival (OS)
OS is defined as the time from randomization to the time of death from any cause. OS is presented.
Up to approximately 47 months
Secondary Outcomes (15)
Part 2: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Up to approximately 19 months
Part 2: Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Up to approximately 48 months
Part 2: Number of Participants Who Experienced an Adverse Event (AE)
Up to approximately 58 months
Part 2: Number of Participants Who Discontinued Study Drug Due to an Adverse Event
Up to approximately 58 months
Part 2: 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] Items 29 and 30) Score
Baseline and Week 27
- +10 more secondary outcomes
Study Arms (2)
Pemetrexed+Platinum Chemotherapy+Pembrolizumab+Lenvatinib
EXPERIMENTALParticipants receive carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m\^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib via oral capsule once daily.
Pemetrexed+Platinum Chemotherapy+Pembrolizumab+Placebo
PLACEBO COMPARATORIn Parts 1 and 2: Participants receive carboplatin AUC5 or cisplatin 75 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS (Part 2 only) placebo matching lenvatinib via oral capsule once daily.
Interventions
IV infusion Q3W
IV infusion Q3W
IV infusion Q3W
IV infusion Q3W
Oral capsule once daily
Oral capsule once daily
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed diagnosis of Stage IV (American Joint Committee on Cancer \[AJCC\], version 8 or current version), nonsquamous NSCLC.
- Confirmation that Epidermal Growth Factor Receptor (EGFR), ALK Receptor Tyrosine Kinase (ALK), or ROS1 Receptor Tyrosine Kinase (ROS1)-directed therapy is not indicated as primary treatment (documentation of absence of tumor-activating EGFR mutations AND absence of ALK and ROS1 gene rearrangements OR presence of a Kirsten Rat Sarcoma (KRAS) gene mutation).
- Have measurable disease based on RECIST 1.1. Note: Lesions that appear measurable, but are situated in a previously irradiated area, can be considered measurable (eligible for selection as target lesions) if they have shown documented growth since the completion of radiation.
- Provided an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion (not previously irradiated).
- Life expectancy of at least 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days prior to the first dose of study intervention but before randomization.
- Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions is more stringent than the requirements above, the local label requirements are to be followed.
- Male participants must agree for at least 7 days after the last dose of lenvatinib/matching placebo and up to 180 days after the last dose of chemotherapeutic agents to:
- Refrain from donating sperm PLUS either:
- Be abstinence from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR
- Must agree to use contraception unless confirmed to be azoopsermic (vasectomized or secondary to medical cause) as detailed below:
- Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile-vaginal penetration.
- Note: 7 days after lenvatinib/matching placebo is stopped, if the participant is on pembrolizumab only and is greater than 180 days post chemotherapy, no male contraception measures are needed.
- Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
- +4 more criteria
You may not qualify if:
- Known untreated central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, clinically stable, and have not required steroids for at least 14 days prior to the first dose of study intervention.
- History of (noninfectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease.
- Known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for at least 3 years since initiation of that therapy. Note: The time requirement also 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.
- Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is allowed.
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention.
- Has had allogeneic tissue/solid organ transplant.
- Known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by the local health authority.
- Known history of Hepatitis B or active Hepatitis C. No testing for Hepatitis B or Hepatitis C is required unless mandated by the local health authority.
- History of a gastrointestinal condition or procedure that in the opinion of the investigator may affect oral drug absorption.
- Active hemoptysis (at least 0.5 teaspoon of bright red blood) within 2 weeks prior to the first dose of study intervention.
- Significant cardiovascular impairment within 12 months prior to the first dose of study intervention, including history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction, cerebrovascular accident (CVA)/stroke, or cardiac arrhythmia associated with hemodynamic instability.
- Known history of active tuberculosis.
- Active infection requiring systemic therapy.
- Has not recovered adequately from any toxicity and/or complication from major surgery prior to the first dose of study intervention.
- Previously had a severe hypersensitivity reaction to treatment with a monoclonal antibody or has a known sensitivity to any component of lenvatinib or pembrolizumab, or as applicable, carboplatin, cisplatin, or pemetrexed.
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Merck Sharp & Dohme LLClead
- Eisai Inc.collaborator
Study Sites (158)
El Camino Hospital Cancer Center ( Site 0529)
Mountain View, California, 94040, United States
Yale University ( Site 0519)
New Haven, Connecticut, 06520-8028, United States
Holy Cross Hospital ( Site 0512)
Fort Lauderdale, Florida, 33308, United States
Mercy Health-Paducah Medical Oncology and Hematology ( Site 0570)
Paducah, Kentucky, 42003, United States
Henry Ford Health System ( Site 0563)
Detroit, Michigan, 48202, United States
Saint Lukes Cancer Institute ( Site 0541)
Kansas City, Missouri, 64111, United States
Broome Oncology, LLC ( Site 0562)
Johnson City, New York, 13790, United States
Sanford Health Roger Maris Cancer Center ( Site 0533)
Fargo, North Dakota, 58122, United States
Stephenson Cancer Center ( Site 0504)
Oklahoma City, Oklahoma, 73104, United States
Good Samaritan Hospital Corvallis ( Site 0521)
Corvallis, Oregon, 97330, United States
Thomas Jefferson University Hospital ( Site 0548)
Philadelphia, Pennsylvania, 19107, United States
Abington Hospital - Asplundh Cancer Center ( Site 0575)
Willow Grove, Pennsylvania, 19090, United States
West Cancer Center - East Campus ( Site 0544)
Germantown, Tennessee, 38138, United States
Parkland Health & Hospital System ( Site 0576)
Dallas, Texas, 75235, United States
UT Southwestern Medical Center ( Site 0558)
Dallas, Texas, 75390, United States
Utah Cancer Specialists ( Site 0523)
Salt Lake City, Utah, 84106, United States
West Virginia University ( Site 0526)
Morgantown, West Virginia, 26506, United States
Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0367)
Berazategui, Buenos Aires, B1884BBF, Argentina
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0371)
Mar del Plata, Buenos Aires, B7600FZO, Argentina
CEMIC ( Site 0370)
Buenos Aires, Buenos Aires F.D., C1431FWO, Argentina
Sanatorio Parque ( Site 0365)
Rosario, Santa Fe Province, S2000DSV, Argentina
Hospital Aleman ( Site 0368)
Buenos Aires, C1118AAT, Argentina
Instituto Medico Especializado Alexander Fleming ( Site 0369)
Buenos Aires, C1426ANZ, Argentina
CEMAIC ( Site 0374)
Córdoba, X5008HHW, Argentina
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica ( Site 0372)
San Juan, J5402DIL, Argentina
Blacktown Hospital Western Sydney Local Health District ( Site 0008)
Blacktown, New South Wales, 2148, Australia
Port Macquarie Base Hospital ( Site 0001)
Port Macquarie, New South Wales, 2444, Australia
Chris OBrien Lifehouse ( Site 0006)
Sydney, New South Wales, 2050, Australia
Westmead Hospital ( Site 0009)
Sydney, New South Wales, 2145, Australia
Cairns Hospital ( Site 0002)
Cairns, Queensland, 4870, Australia
The Prince Charles Hospital ( Site 0010)
Chermside, Queensland, 4032, Australia
Ballarat Health Services ( Site 0003)
Ballarat, Victoria, 3350, Australia
Moncton Hospital - Horizon Health Network ( Site 0410)
Moncton, New Brunswick, E1C 6Z8, Canada
Juravinski Cancer Centre ( Site 0407)
Hamilton, Ontario, L8V 1C3, Canada
Kingston Health Sciences Centre ( Site 0414)
Kingston, Ontario, K7L 2V7, Canada
Lakeridge Health ( Site 0406)
Oshawa, Ontario, L1G 2B9, Canada
Sault Area Hospital ( Site 0413)
Sault Ste. Marie, Ontario, P6B 0A8, Canada
Hopital Cite de la Sante de Laval ( Site 0400)
Laval, Quebec, H7M 3L9, Canada
CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0412)
Montreal, Quebec, H3T 1M5, Canada
CHU de Quebec-Universite Laval-Hotel Dieu de Quebec ( Site 0403)
Québec, Quebec, G1R 2J6, Canada
CIUSSS de la Mauricie et du Centre du Quebec ( Site 0408)
Trois-Rivières, Quebec, G8Z 3R9, Canada
Clinica Universidad Catolica del Maule ( Site 0385)
Talca, Maule Region, 3465584, Chile
OrlandiOncologia ( Site 0381)
Santiago, Region M. de Santiago, 7500713, Chile
Fundacion Arturo Lopez Perez FALP ( Site 0383)
Santiago, Region M. de Santiago, 7500921, Chile
Pontificia Universidad Catolica de Chile ( Site 0382)
Santiago, Region M. de Santiago, 8330032, Chile
Bradford Hill Centro de Investigaciones Clinicas ( Site 0387)
Santiago, Region M. de Santiago, 8420383, Chile
Centro de Investigacion y desarrollo Oncologico SpA - CIDO SpA ( Site 0380)
Temuco, Región de la Araucanía, 4810218, Chile
Oncocentro ( Site 0384)
Viña del Mar, Región de Valparaíso, 2520598, Chile
Centro Oncologico Antofagasta ( Site 0386)
Antofagasta, 1240000, Chile
Peking Union Medical College Hospital ( Site 0108)
Beijing, Beijing Municipality, 100006, China
Cancer Hospital Chinese Academy of Medical Science ( Site 0117)
Beijing, Beijing Municipality, 100021, China
Beijing Cancer Hospital ( Site 0120)
Beijing, Beijing Municipality, 100036, China
The Second Hospital Affiliated to AMU ( Site 0119)
Chongqing, Chongqing Municipality, 400037, China
First Affiliated Hospital of The Third Military Medical University ( Site 0118)
Chongqing, Chongqing Municipality, 400038, China
Fujian Provincial Cancer Hospital ( Site 0102)
Fuzhou, Fujian, 350014, China
Southern Medical University Nanfang Hospital ( Site 0121)
Guangzhou, Guangdong, 510515, China
The Third Affiliated Hospital of Harbin Medical University ( Site 0100)
Harbin, Heilongjiang, 150081, China
Henan Cancer Hospital ( Site 0112)
Zhengzhou, Henan, 450008, China
Wuhan Union Hospital Cancer Center-Cancer Center ( Site 0123)
Wuhan, Hubei, 430022, China
Hubei Cancer Hospital ( Site 0122)
Wuhan, Hubei, 430079, China
Jilin Cancer Hospital ( Site 0115)
Changchun, Jilin, 130103, China
Zhongshan Hospital Fudan University ( Site 0103)
Shanghai, Shanghai Municipality, 200032, China
Shanghai Pulmonary Hospital ( Site 0101)
Shanghai, Shanghai Municipality, 200443, China
Tianjin Medical University Cancer Institute & Hospital ( Site 0111)
Tianjin, Tianjin Municipality, 300060, China
Cancer Hospital Affiliated to Xinjiang Medical University ( Site 0110)
Urumuqi, Xinjiang, 830000, China
The First Affiliated Hospital Zhejiang University ( Site 0109)
Hangzhou, Zhejiang, 310003, China
Zhejiang Cancer Hospital ( Site 0113)
Hangzhou, Zhejiang, 310022, China
The First Affiliated Hospital of Wenzhou Medical University ( Site 0124)
Wenzhou, Zhejiang, 325000, China
Hopital Cardiologique Louis Pradel ( Site 0141)
Bron, Auvergne-Rhône-Alpes, 69500, France
Centre Paul Strauss ( Site 0144)
Strasbourg, Bas-Rhin, 67065, France
Hopital Nord du Marseille ( Site 0147)
Marseille, Bouches-du-Rhone, 13015, France
Hopital Foch ( Site 0145)
Suresnes, Hauts-de-Seine, 92151, France
Centre de Cancerologie du Grand Montpellier ( Site 0142)
Montpellier, Herault, 34070, France
Hopital Laennec ( Site 0146)
Nantes, Loire-Atlantique, 44093, France
Hopital Robert Schuman ( Site 0143)
Vantoux, Moselle, 57070, France
L'hopital Nord-Ouest - Centre Hospitalier de Villefranche sur Saone ( Site 0149)
Villefranche-sur-Saône, Rhone, 69655, France
Hopital Cochin ( Site 0140)
Paris, 75014, France
Klinikum Esslingen GmbH ( Site 0164)
Esslingen am Neckar, Baden-Wurttemberg, 73730, Germany
Krankenhaus Nordwest ( Site 0169)
Frankfurt am Main, Hesse, 60488, Germany
Pius Hospital Oldenburg ( Site 0170)
Oldenburg, Lower Saxony, 26121, Germany
Uniklinik RWTH Aachen ( Site 0160)
Aachen, North Rhine-Westphalia, 52074, Germany
Universitaetsklinikum des Saarlandes ( Site 0165)
Homburg, Saarland, 66421, Germany
Krankenhaus Martha Maria Halle-Doelau ( Site 0166)
Halle, Saxony-Anhalt, 06120, Germany
LungenClinic Grosshansdorf GmbH ( Site 0171)
Großhansdorf, Schleswig-Holstein, 22927, Germany
Hamato-Onkologie Hamburg Prof. Laack und Partner ( Site 0161)
Hamburg, 20251, Germany
Soroka Medical Center ( Site 0222)
Beersheba, 8410101, Israel
Rambam Medical Center ( Site 0223)
Haifa, 3109601, Israel
Shaare Zedek Medical Center-Oncology ( Site 0229)
Jerusalem, 9013102, Israel
Meir Medical Center ( Site 0221)
Kfar Saba, 4428164, Israel
Holy Family Hospital ( Site 0228)
Nazareth, 1641101, Israel
Rabin Medical Center ( Site 0224)
Petah Tikva, 4941492, Israel
Sheba Medical Center ( Site 0220)
Ramat Gan, 5262000, Israel
Sourasky Medical Center ( Site 0225)
Tel Aviv, 6423906, Israel
Shamir Medical Center-Assaf Harofeh ( Site 0227)
Ẕerifin, 70300, Israel
National Hospital Organization Nagoya Medical Center ( Site 0017)
Nagoya, Aichi-ken, 460-0001, Japan
Fujita Health University Hospital ( Site 0016)
Toyoake, Aichi-ken, 470-1192, Japan
National Cancer Center Hospital East ( Site 0024)
Kashiwa, Chiba, 277-8577, Japan
Kanazawa University Hospital ( Site 0018)
Kanazawa, Ishikawa-ken, 920-8641, Japan
Osaka Habikino Medical Center ( Site 0020)
Habikino, Osaka, 583-8588, Japan
Kansai Medical University Hospital ( Site 0022)
Hirakata, Osaka, 573-1191, Japan
Niigata Cancer Center Hospital ( Site 0019)
Niigata, 951-8566, Japan
National Cancer Center Hospital ( Site 0026)
Tokyo, 104-0045, Japan
Tokyo Metropolitan Komagome Hospital ( Site 0015)
Tokyo, 113-8677, Japan
The Cancer Institute Hospital of JFCR ( Site 0021)
Tokyo, 135-8550, Japan
Wakayama Medical University Hospital ( Site 0025)
Wakayama, 641-8510, Japan
Tauranga Hospital ( Site 0004)
Tauranga, Bay of Plenty, 3112, New Zealand
Auckland City Hospital ( Site 0011)
Auckland, 1023, New Zealand
Pleszewskie Centrum Medyczne w Pleszewie Sp. z o.o. ( Site 0615)
Pleszew, Greater Poland Voivodeship, 63-300, Poland
MED-POLONIA Sp. z o.o. ( Site 0609)
Poznan, Greater Poland Voivodeship, 60-693, Poland
Centrum Onkologii im.prof. F. Lukaszczyka w Bydgoszczy ( Site 0601)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0603)
Warsaw, Masovian Voivodeship, 02-781, Poland
Szpital Wojewodzki im. Mikolaja Kopernika ( Site 0602)
Koszalin, West Pomeranian Voivodeship, 75-581, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii ( Site 0613)
Lodz, Łódź Voivodeship, 93-513, Poland
Leningrad Regional Oncology Center ( Site 0271)
Saint Petersburg, Leningradskaya Oblast', 197758, Russia
City Clinical Hospital 1 na. NI. Pirogov ( Site 0270)
Moscow, Moscow, 119049, Russia
Central Clinical Hospital with outpatient Clinic ( Site 0262)
Moscow, Moscow, 121359, Russia
National Medical Research Radiology Centre ( Site 0260)
Moscow, Moscow, 125284, Russia
FSAI Treatment and Rehabilitation Centre of the MoH and SD of RF ( Site 0264)
Moscow, Moscow, 125367, Russia
Moscow Regional Oncological Dispensary ( Site 0274)
Balashikha, Moscow Oblast, 143900, Russia
Nizhniy Novgorod Region Oncology Dispensary ( Site 0272)
Nizhny Novgorod, Nizhny Novgorod Oblast, 603081, Russia
Omsk Clinical Oncology Dispensary ( Site 0267)
Omsk, Omsk Oblast, 644013, Russia
First Pavlov State Medical University of Saint Petersburg-Department of Oncology ( Site 0273)
Saint Petersburg, Sankt-Peterburg, 197022, Russia
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0269)
Saint Petersburg, Sankt-Peterburg, 197758, Russia
SAHI Republican Clinical Oncological Dispensary of the MoH of RT ( Site 0261)
Kazan', Tatarstan, Respublika, 420029, Russia
National Cancer Center ( Site 0061)
Goyang-si, Kyonggi-do, 10408, South Korea
The Catholic University of Korea St. Vincent s Hospital ( Site 0064)
Gyeonggi-do, Kyonggi-do, 16247, South Korea
Chungbuk National University Hospital ( Site 0062)
Cheongju-si, North Chungcheong, 28644, South Korea
Severance Hospital Yonsei University Health System ( Site 0063)
Seoul, 03722, South Korea
ICO L Hospitalet ( Site 0234)
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Complejo Hospitalario Universitario A Coruna ( Site 0239)
A Coruña, La Coruna, 15006, Spain
Hospital Universitario Insular de Gran Canaria ( Site 0244)
Las Palmas de Gran Canaria, Las Palmas, 35001, Spain
Hospital General Universitario de Valencia ( Site 0231)
Valencia, Valenciana, Comunitat, 46014, Spain
Hospital Universitario La Fe ( Site 0233)
Valencia, Valenciana, Comunitat, 46026, Spain
Hospital General Universitario de Alicante ( Site 0240)
Alicante, 03010, Spain
Hospital Santa Creu i Sant Pau ( Site 0241)
Barcelona, 08025, Spain
Hospital General Universitario Gregorio Maranon ( Site 0237)
Madrid, 28009, Spain
Hospital Clinico San Carlos ( Site 0235)
Madrid, 28040, Spain
Hospital Universitario La Paz ( Site 0236)
Madrid, 28046, Spain
Complejo Hospitalario de Malaga ( Site 0238)
Málaga, 29010, Spain
Hospital Universitario Miguel Servet ( Site 0242)
Zaragoza, 50009, Spain
Cukurova Universitesi Tıp Fakultesi Balcalı Hastanesi ( Site 0314)
Adana, 01330, Turkey (Türkiye)
Hacettepe Universitesi Tıp Fakultesi ( Site 0316)
Ankara, 06100, Turkey (Türkiye)
Ankara Universitesi Tip Fakultesi. ( Site 0317)
Ankara, 06620, Turkey (Türkiye)
Ankara Sehir Hastanesi ( Site 0323)
Ankara, 06800, Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0312)
Istanbul, 34098, Turkey (Türkiye)
Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0310)
Istanbul, 34722, Turkey (Türkiye)
Ege Universitesi Tip Fakultesi ( Site 0313)
Izmir, 35100, Turkey (Türkiye)
Inonu Universitesi Medical Fakultesi ( Site 0318)
Malatya, 44280, Turkey (Türkiye)
Cambridge University Hospitals NHS Trust ( Site 0293)
Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom
North Middlesex University Hospital NHS Trust ( Site 0291)
London, London, City of, N18 1QX, United Kingdom
Guys and St Thomas NHS Foundation Trust ( Site 0280)
London, London, City of, SE1 9RT, United Kingdom
St Georges University Hospitals NHS Foundation Trust. ( Site 0292)
London, London, City of, SW17 0QT, United Kingdom
Aberdeen Royal Infirmary ( Site 0288)
Aberdeen, Scotland, AB25 2ZN, United Kingdom
Leeds Teaching Hospital NHS Trust. St. James University Hospital ( Site 0276)
Leeds, LS9 7TF, United Kingdom
Leicester Royal Infirmary ( Site 0284)
Leicester, LE1 5WW, United Kingdom
Christie NHS Foundation Trust ( Site 0275)
Manchester, M20 4BX, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust ( Site 0286)
Metropolitan Borough of Wirral, CH63 4JY, United Kingdom
Nottingham City Hospital Campus ( Site 0287)
Nottingham, NG5 1PB, United Kingdom
Related Publications (1)
Herbst RS, Cho BC, Zhou C, Burotto M, Dols MC, Sendur MAN, Moiseyenko V, Casarini I, Nishio M, Hui R, Pons-Tostivint E, Dudnik J, Ahmed S, Okpara CE, Dutcus C, Yin L, Luo Y, Chirovsky D, Bhagwati N, Abreu DR. Lenvatinib Plus Pembrolizumab, Pemetrexed, and a Platinum as First-Line Therapy for Metastatic Nonsquamous NSCLC: Phase 3 LEAP-006 Study. J Thorac Oncol. 2025 Sep;20(9):1302-1314. doi: 10.1016/j.jtho.2025.05.016. Epub 2025 May 24.
PMID: 40419140RESULT
Related Links
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme LLC
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2019
First Posted
February 4, 2019
Study Start
March 25, 2019
Primary Completion
August 11, 2023
Study Completion
August 30, 2024
Last Updated
February 5, 2026
Results First Posted
February 21, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf