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)

NCT ID: NCT03829319

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 761 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-25
• Study Completion Date: 2024-08-30

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.

Conditions

Nonsquamous Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Pemetrexed+Platinum Chemotherapy+Pembrolizumab+Lenvatinib

Participants 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.

Group Type: EXPERIMENTAL

Pembrolizumab

Intervention Type: BIOLOGICAL

IV infusion Q3W

Carboplatin

Intervention Type: DRUG

IV infusion Q3W

Cisplatin

Intervention Type: DRUG

IV infusion Q3W

Pemetrexed

Intervention Type: DRUG

IV infusion Q3W

Lenvatinib

Intervention Type: DRUG

Oral capsule once daily

Pemetrexed+Platinum Chemotherapy+Pembrolizumab+Placebo

In 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.

Group Type: PLACEBO_COMPARATOR

Pembrolizumab

Intervention Type: BIOLOGICAL

IV infusion Q3W

Carboplatin

Intervention Type: DRUG

IV infusion Q3W

Cisplatin

Intervention Type: DRUG

IV infusion Q3W

Pemetrexed

Intervention Type: DRUG

IV infusion Q3W

Placebo matching lenvatinib

Intervention Type: DRUG

Oral capsule once daily

Interventions

Pembrolizumab

IV infusion Q3W

Intervention Type: BIOLOGICAL

Carboplatin

IV infusion Q3W

Intervention Type: DRUG

Cisplatin

IV infusion Q3W

Intervention Type: DRUG

Pemetrexed

IV infusion Q3W

Intervention Type: DRUG

Lenvatinib

Oral capsule once daily

Intervention Type: DRUG

Placebo matching lenvatinib

Oral capsule once daily

Intervention Type: DRUG

Other Intervention Names

MK-3475; MK-7902; E7080

Eligibility Criteria

Inclusion Criteria

• 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:

1. Refrain from donating sperm PLUS either:

2. 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

3. Must agree to use contraception unless confirmed to be azoopsermic (vasectomized or secondary to medical cause) as detailed below:

1. 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:

1. Is not a WOCBP OR

2. Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the intervention period and for at least 120 days post pembrolizumab and/or 30 days post-lenvatinib/matching placebo, and up to 180 days post last dose of chemotherapeutic agents, whichever occurs last.

• Adequate organ function.
• 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 prior to randomization. Note: Participants must not have a history of uncontrolled or poorly-controlled hypertension, defined as >150/90 mm Hg for >4 weeks despite standard medical management.

Exclusion Criteria

• 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.
• Radiographic evidence of intratumoral caviations, encasement, or invasion of a major blood vessel. Additionally, the degree of proximity to major blood vessels should be considered for exclusion because of the potential risk of severe hemorrhage associated with tumor shrinkage/necrosis after lenvatinib-therapy. (In the chest, major blood vessels include the main pulmonary artery, the left and right pulmonary arteries, the 4 major pulmonary veins, the superior or inferior vena cava, and the aorta).
• 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.
• A WOCBP who has a positive urine pregnancy test within 24 hours prior to randomization or treatment allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
• Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula.
• Received prior systemic chemotherapy or other targeted or biological antineoplastic therapy for their metastatic NSCLC. Note: Prior treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as therapy was completed at least 6 months prior to the diagnosis of metastatic NSCLC.
• Received prior treatment with pembrolizumab or any other anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2 agent, with lenvatinib or any other receptor tyrosine kinase inhibitor (RTKi), or with an agent directed to another stimulatory or co-inhibitory T cell receptor.
• Received radiotherapy within 14 days prior to the first dose of study intervention or received lung radiation therapy of >30 Gy within 6 months prior to the first dose of study intervention. Note: Participants must have recovered from all radiation-related toxicities to Grade ≤1, not required corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
• Received systemic steroid therapy (in doses exceeding 10 mg daily of prednisone equivalent) within 7 days prior to the first dose of study intervention.
• Received a live or live attenuated vaccine within 30 days prior to the first dose of study intervention. Note: killed vaccines are allowed.
• Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to the first dose of study intervention.
• Has a prolongation of QTc interval (calculated using Fridericia's formula) of >480 msecl.
• Left ventricular ejection fraction (LVEF) below the institutional (or local laboratory) normal range as determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO).
• Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Inc.

INDUSTRY

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

El Camino Hospital Cancer Center ( Site 0529)

Mountain View, California, United States

Yale University ( Site 0519)

New Haven, Connecticut, United States

Holy Cross Hospital ( Site 0512)

Fort Lauderdale, Florida, United States

Mercy Health-Paducah Medical Oncology and Hematology ( Site 0570)

Paducah, Kentucky, United States

Henry Ford Health System ( Site 0563)

Detroit, Michigan, United States

Saint Lukes Cancer Institute ( Site 0541)

Kansas City, Missouri, United States

Broome Oncology, LLC ( Site 0562)

Johnson City, New York, United States

Sanford Health Roger Maris Cancer Center ( Site 0533)

Fargo, North Dakota, United States

Stephenson Cancer Center ( Site 0504)

Oklahoma City, Oklahoma, United States

Good Samaritan Hospital Corvallis ( Site 0521)

Corvallis, Oregon, United States

Thomas Jefferson University Hospital ( Site 0548)

Philadelphia, Pennsylvania, United States

Abington Hospital - Asplundh Cancer Center ( Site 0575)

Willow Grove, Pennsylvania, United States

West Cancer Center - East Campus ( Site 0544)

Germantown, Tennessee, United States

Parkland Health & Hospital System ( Site 0576)

Dallas, Texas, United States

UT Southwestern Medical Center ( Site 0558)

Dallas, Texas, United States

Utah Cancer Specialists ( Site 0523)

Salt Lake City, Utah, United States

West Virginia University ( Site 0526)

Morgantown, West Virginia, United States

Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0367)

Berazategui, Buenos Aires, Argentina

Instituto de Investigaciones Clinicas Mar del Plata ( Site 0371)

Mar del Plata, Buenos Aires, Argentina

CEMIC ( Site 0370)

Buenos Aires, Buenos Aires F.D., Argentina

Sanatorio Parque ( Site 0365)

Rosario, Santa Fe Province, Argentina

Hospital Aleman ( Site 0368)

Buenos Aires, , Argentina

Instituto Medico Especializado Alexander Fleming ( Site 0369)

Buenos Aires, , Argentina

CEMAIC ( Site 0374)

Córdoba, , Argentina

CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica ( Site 0372)

San Juan, , Argentina

Blacktown Hospital Western Sydney Local Health District ( Site 0008)

Blacktown, New South Wales, Australia

Port Macquarie Base Hospital ( Site 0001)

Port Macquarie, New South Wales, Australia

Chris OBrien Lifehouse ( Site 0006)

Sydney, New South Wales, Australia

Westmead Hospital ( Site 0009)

Sydney, New South Wales, Australia

Cairns Hospital ( Site 0002)

Cairns, Queensland, Australia

The Prince Charles Hospital ( Site 0010)

Chermside, Queensland, Australia

Ballarat Health Services ( Site 0003)

Ballarat, Victoria, Australia

Moncton Hospital - Horizon Health Network ( Site 0410)

Moncton, New Brunswick, Canada

Juravinski Cancer Centre ( Site 0407)

Hamilton, Ontario, Canada

Kingston Health Sciences Centre ( Site 0414)

Kingston, Ontario, Canada

Lakeridge Health ( Site 0406)

Oshawa, Ontario, Canada

Sault Area Hospital ( Site 0413)

Sault Ste. Marie, Ontario, Canada

Hopital Cite de la Sante de Laval ( Site 0400)

Laval, Quebec, Canada

CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0412)

Montreal, Quebec, Canada

CHU de Quebec-Universite Laval-Hotel Dieu de Quebec ( Site 0403)

Québec, Quebec, Canada

CIUSSS de la Mauricie et du Centre du Quebec ( Site 0408)

Trois-Rivières, Quebec, Canada

Clinica Universidad Catolica del Maule ( Site 0385)

Talca, Maule Region, Chile

OrlandiOncologia ( Site 0381)

Santiago, Region M. de Santiago, Chile

Fundacion Arturo Lopez Perez FALP ( Site 0383)

Santiago, Region M. de Santiago, Chile

Pontificia Universidad Catolica de Chile ( Site 0382)

Santiago, Region M. de Santiago, Chile

Bradford Hill Centro de Investigaciones Clinicas ( Site 0387)

Santiago, Region M. de Santiago, Chile

Centro de Investigacion y desarrollo Oncologico SpA - CIDO SpA ( Site 0380)

Temuco, Región de la Araucanía, Chile

Oncocentro ( Site 0384)

Viña del Mar, Región de Valparaíso, Chile

Centro Oncologico Antofagasta ( Site 0386)

Antofagasta, , Chile

Peking Union Medical College Hospital ( Site 0108)

Beijing, Beijing Municipality, China

Cancer Hospital Chinese Academy of Medical Science ( Site 0117)

Beijing, Beijing Municipality, China

Beijing Cancer Hospital ( Site 0120)

Beijing, Beijing Municipality, China

The Second Hospital Affiliated to AMU ( Site 0119)

Chongqing, Chongqing Municipality, China

First Affiliated Hospital of The Third Military Medical University ( Site 0118)

Chongqing, Chongqing Municipality, China

Fujian Provincial Cancer Hospital ( Site 0102)

Fuzhou, Fujian, China

Southern Medical University Nanfang Hospital ( Site 0121)

Guangzhou, Guangdong, China

The Third Affiliated Hospital of Harbin Medical University ( Site 0100)

Harbin, Heilongjiang, China

Henan Cancer Hospital ( Site 0112)

Zhengzhou, Henan, China

Wuhan Union Hospital Cancer Center-Cancer Center ( Site 0123)

Wuhan, Hubei, China

Hubei Cancer Hospital ( Site 0122)

Wuhan, Hubei, China

Jilin Cancer Hospital ( Site 0115)

Changchun, Jilin, China

Zhongshan Hospital Fudan University ( Site 0103)

Shanghai, Shanghai Municipality, China

Shanghai Pulmonary Hospital ( Site 0101)

Shanghai, Shanghai Municipality, China

Tianjin Medical University Cancer Institute & Hospital ( Site 0111)

Tianjin, Tianjin Municipality, China

Cancer Hospital Affiliated to Xinjiang Medical University ( Site 0110)

Urumuqi, Xinjiang, China

The First Affiliated Hospital Zhejiang University ( Site 0109)

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital ( Site 0113)

Hangzhou, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University ( Site 0124)

Wenzhou, Zhejiang, China

Hopital Cardiologique Louis Pradel ( Site 0141)

Bron, Auvergne-Rhône-Alpes, France

Centre Paul Strauss ( Site 0144)

Strasbourg, Bas-Rhin, France

Hopital Nord du Marseille ( Site 0147)

Marseille, Bouches-du-Rhone, France

Hopital Foch ( Site 0145)

Suresnes, Hauts-de-Seine, France

Centre de Cancerologie du Grand Montpellier ( Site 0142)

Montpellier, Herault, France

Hopital Laennec ( Site 0146)

Nantes, Loire-Atlantique, France

Hopital Robert Schuman ( Site 0143)

Vantoux, Moselle, France

L'hopital Nord-Ouest - Centre Hospitalier de Villefranche sur Saone ( Site 0149)

Villefranche-sur-Saône, Rhone, France

Hopital Cochin ( Site 0140)

Paris, , France

Klinikum Esslingen GmbH ( Site 0164)

Esslingen am Neckar, Baden-Wurttemberg, Germany

Krankenhaus Nordwest ( Site 0169)

Frankfurt am Main, Hesse, Germany

Pius Hospital Oldenburg ( Site 0170)

Oldenburg, Lower Saxony, Germany

Uniklinik RWTH Aachen ( Site 0160)

Aachen, North Rhine-Westphalia, Germany

Universitaetsklinikum des Saarlandes ( Site 0165)

Homburg, Saarland, Germany

Krankenhaus Martha Maria Halle-Doelau ( Site 0166)

Halle, Saxony-Anhalt, Germany

LungenClinic Grosshansdorf GmbH ( Site 0171)

Großhansdorf, Schleswig-Holstein, Germany

Hamato-Onkologie Hamburg Prof. Laack und Partner ( Site 0161)

Hamburg, , Germany

Soroka Medical Center ( Site 0222)

Beersheba, , Israel

Rambam Medical Center ( Site 0223)

Haifa, , Israel

Shaare Zedek Medical Center-Oncology ( Site 0229)

Jerusalem, , Israel

Meir Medical Center ( Site 0221)

Kfar Saba, , Israel

Holy Family Hospital ( Site 0228)

Nazareth, , Israel

Rabin Medical Center ( Site 0224)

Petah Tikva, , Israel

Sheba Medical Center ( Site 0220)

Ramat Gan, , Israel

Sourasky Medical Center ( Site 0225)

Tel Aviv, , Israel

Shamir Medical Center-Assaf Harofeh ( Site 0227)

Ẕerifin, , Israel

National Hospital Organization Nagoya Medical Center ( Site 0017)

Nagoya, Aichi-ken, Japan

Fujita Health University Hospital ( Site 0016)

Toyoake, Aichi-ken, Japan

National Cancer Center Hospital East ( Site 0024)

Kashiwa, Chiba, Japan

Kanazawa University Hospital ( Site 0018)

Kanazawa, Ishikawa-ken, Japan

Osaka Habikino Medical Center ( Site 0020)

Habikino, Osaka, Japan

Kansai Medical University Hospital ( Site 0022)

Hirakata, Osaka, Japan

Niigata Cancer Center Hospital ( Site 0019)

Niigata, , Japan

National Cancer Center Hospital ( Site 0026)

Tokyo, , Japan

Tokyo Metropolitan Komagome Hospital ( Site 0015)

Tokyo, , Japan

The Cancer Institute Hospital of JFCR ( Site 0021)

Tokyo, , Japan

Wakayama Medical University Hospital ( Site 0025)

Wakayama, , Japan

Tauranga Hospital ( Site 0004)

Tauranga, Bay of Plenty, New Zealand

Auckland City Hospital ( Site 0011)

Auckland, , New Zealand

Pleszewskie Centrum Medyczne w Pleszewie Sp. z o.o. ( Site 0615)

Pleszew, Greater Poland Voivodeship, Poland

MED-POLONIA Sp. z o.o. ( Site 0609)

Poznan, Greater Poland Voivodeship, Poland

Centrum Onkologii im.prof. F. Lukaszczyka w Bydgoszczy ( Site 0601)

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0603)

Warsaw, Masovian Voivodeship, Poland

Szpital Wojewodzki im. Mikolaja Kopernika ( Site 0602)

Koszalin, West Pomeranian Voivodeship, Poland

Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii ( Site 0613)

Lodz, Łódź Voivodeship, Poland

Leningrad Regional Oncology Center ( Site 0271)

Saint Petersburg, Leningradskaya Oblast', Russia

City Clinical Hospital 1 na. NI. Pirogov ( Site 0270)

Moscow, Moscow, Russia

Central Clinical Hospital with outpatient Clinic ( Site 0262)

Moscow, Moscow, Russia

National Medical Research Radiology Centre ( Site 0260)

Moscow, Moscow, Russia

FSAI Treatment and Rehabilitation Centre of the MoH and SD of RF ( Site 0264)

Moscow, Moscow, Russia

Moscow Regional Oncological Dispensary ( Site 0274)

Balashikha, Moscow Oblast, Russia

Nizhniy Novgorod Region Oncology Dispensary ( Site 0272)

Nizhny Novgorod, Nizhny Novgorod Oblast, Russia

Omsk Clinical Oncology Dispensary ( Site 0267)

Omsk, Omsk Oblast, Russia

First Pavlov State Medical University of Saint Petersburg-Department of Oncology ( Site 0273)

Saint Petersburg, Sankt-Peterburg, Russia

Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0269)

Saint Petersburg, Sankt-Peterburg, Russia

SAHI Republican Clinical Oncological Dispensary of the MoH of RT ( Site 0261)

Kazan', Tatarstan, Respublika, Russia

National Cancer Center ( Site 0061)

Goyang-si, Kyonggi-do, South Korea

The Catholic University of Korea St. Vincent s Hospital ( Site 0064)

Gyeonggi-do, Kyonggi-do, South Korea

Chungbuk National University Hospital ( Site 0062)

Cheongju-si, North Chungcheong, South Korea

Severance Hospital Yonsei University Health System ( Site 0063)

Seoul, , South Korea

ICO L Hospitalet ( Site 0234)

L'Hospitalet de Llobregat, Barcelona, Spain

Complejo Hospitalario Universitario A Coruna ( Site 0239)

A Coruña, La Coruna, Spain

Hospital Universitario Insular de Gran Canaria ( Site 0244)

Las Palmas de Gran Canaria, Las Palmas, Spain

Hospital General Universitario de Valencia ( Site 0231)

Valencia, Valenciana, Comunitat, Spain

Hospital Universitario La Fe ( Site 0233)

Valencia, Valenciana, Comunitat, Spain

Hospital General Universitario de Alicante ( Site 0240)

Alicante, , Spain

Hospital Santa Creu i Sant Pau ( Site 0241)

Barcelona, , Spain

Hospital General Universitario Gregorio Maranon ( Site 0237)

Madrid, , Spain

Hospital Clinico San Carlos ( Site 0235)

Madrid, , Spain

Hospital Universitario La Paz ( Site 0236)

Madrid, , Spain

Complejo Hospitalario de Malaga ( Site 0238)

Málaga, , Spain

Hospital Universitario Miguel Servet ( Site 0242)

Zaragoza, , Spain

Cukurova Universitesi Tıp Fakultesi Balcalı Hastanesi ( Site 0314)

Adana, , Turkey (Türkiye)

Hacettepe Universitesi Tıp Fakultesi ( Site 0316)

Ankara, , Turkey (Türkiye)

Ankara Universitesi Tip Fakultesi. ( Site 0317)

Ankara, , Turkey (Türkiye)

Ankara Sehir Hastanesi ( Site 0323)

Ankara, , Turkey (Türkiye)

Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0312)

Istanbul, , Turkey (Türkiye)

Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0310)

Istanbul, , Turkey (Türkiye)

Ege Universitesi Tip Fakultesi ( Site 0313)

Izmir, , Turkey (Türkiye)

Inonu Universitesi Medical Fakultesi ( Site 0318)

Malatya, , Turkey (Türkiye)

Cambridge University Hospitals NHS Trust ( Site 0293)

Cambridge, Cambridgeshire, United Kingdom

North Middlesex University Hospital NHS Trust ( Site 0291)

London, London, City of, United Kingdom

Guys and St Thomas NHS Foundation Trust ( Site 0280)

London, London, City of, United Kingdom

St Georges University Hospitals NHS Foundation Trust. ( Site 0292)

London, London, City of, United Kingdom

Aberdeen Royal Infirmary ( Site 0288)

Aberdeen, Scotland, United Kingdom

Leeds Teaching Hospital NHS Trust. St. James University Hospital ( Site 0276)

Leeds, , United Kingdom

Leicester Royal Infirmary ( Site 0284)

Leicester, , United Kingdom

Christie NHS Foundation Trust ( Site 0275)

Manchester, , United Kingdom

The Clatterbridge Cancer Centre NHS Foundation Trust ( Site 0286)

Metropolitan Borough of Wirral, , United Kingdom

Nottingham City Hospital Campus ( Site 0287)

Nottingham, , United Kingdom

Countries

United States; Argentina; Australia; Canada; Chile; China; France; Germany; Israel; Japan; New Zealand; Poland; Russia; South Korea; Spain; Turkey (Türkiye); United Kingdom

References

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.

Reference Type: RESULT

PMID: 40419140 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.merckclinicaltrials.com/

Merck Clinical Trials Information

Other Identifiers

MK-7902-006

Identifier Type: OTHER

Identifier Source: secondary_id

E7080-G000-315

Identifier Type: OTHER

Identifier Source: secondary_id

LEAP-006

Identifier Type: OTHER

Identifier Source: secondary_id

194658

Identifier Type: REGISTRY

Identifier Source: secondary_id

2018-003824-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

7902-006

Identifier Type: -

Identifier Source: org_study_id