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)

NCT ID: NCT03976375

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 422 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-26
• Study Completion Date: 2024-08-22

Brief Summary

This study will evaluate the 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 treatment with one prior anti-PD-1/PD-L1 monoclonal antibody (mAb). The primary hypotheses of this study are that pembrolizumab + lenvatinib (compared with docetaxel) prolongs: 1) overall survival (OS); and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review (BICR).

Conditions

Metastatic Non-Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pembrolizumab+Lenvatinib

Participants receive pembrolizumab at 200 mg, every 3 weeks (Q3W) via intravenous (IV) infusion on Day 1 of each 21-day cycle, in combination with lenvatinib at 20 mg, once daily (QD) via oral capsule. Pembrolizumab will be administered for up to 35 treatment cycles (\~2 years). Lenvantinib will be administered until progressive disease or unacceptable toxicity.

Group Type: EXPERIMENTAL

Pembrolizumab

Intervention Type: BIOLOGICAL

IV infusion of pembrolizumab at 200 mg

Lenvatinib

Intervention Type: DRUG

Oral capsules (unit strength: 4 and 10 mg) at 20 mg or 24 mg total daily dose.

Docetaxel

Participants receive docetaxel at 75 mg/m\^2, Q3W via IV infusion over 1-hour infusion on Day 1 of each 21-day cycle. Docetaxel will be administered until progressive disease or unacceptable toxicity.

Group Type: ACTIVE_COMPARATOR

Docetaxel

Intervention Type: DRUG

IV infusion of docetaxel at 75 mg/m\^2.

Lenvatinib Monotherapy

Participants receive lenvatinib at 24 mg, QD via oral capsule. Lenvantinib will be administered until progressive disease or unacceptable toxicity.

Group Type: EXPERIMENTAL

Lenvatinib

Intervention Type: DRUG

Oral capsules (unit strength: 4 and 10 mg) at 20 mg or 24 mg total daily dose.

Interventions

Pembrolizumab

IV infusion of pembrolizumab at 200 mg

Intervention Type: BIOLOGICAL

Lenvatinib

Oral capsules (unit strength: 4 and 10 mg) at 20 mg or 24 mg total daily dose.

Intervention Type: DRUG

Docetaxel

IV infusion of docetaxel at 75 mg/m\^2.

Intervention Type: DRUG

Other Intervention Names

MK-3475; KEYTRUDA®; MK-7902; E7080; LENVIMA®; TAXOTERE®

Eligibility Criteria

Inclusion Criteria

• Has a histologically or cytologically confirmed diagnosis of metastatic squamous or nonsquamous Non-Small Cell Lung Cancer (NSCLC) -Stage IV: M1a, M1b, M1c.
• Has progressive disease (PD) on treatment with one prior anti-programmed cell death 1 (PD-1)/programmed cell death ligand 1 (PD-L1) monoclonal antibody (mAb) administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies.

• Retreatment with the same anti-PD-L1/PD-L1 mAb is acceptable in the overall course of treatment
• Has PD during/after platinum doublet chemotherapy for metastatic disease.
• Has confirmation that EGFR-, ALK-, or ROS1-directed therapy is not indicated as primary therapy (documentation of absence of tumor-activating EGFR mutations [eg, DEL19 or L858R], and absence of ALK and ROS1 gene rearrangements OR presence of a K-ras mutation).
• Has submitted pre-study imaging that confirmed evidence of PD following initiation of an anti-PD-1/PD-L1 inhibitor.
• Has at least 1 measurable lesion by computerized tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, as determined by the local site assessment.
• Has provided tumor tissue for PD-L1 biomarker analysis from an archival sample (defined as: from initial diagnosis of NSCLC and prior to receiving immunotherapy [antiPD-1/PD-L1], from the primary lesion or a metastatic lesion).
• Has provided prior to allocation tissue from a newly obtained formalin-fixed sample from a new biopsy (defined as: after completion of immunotherapy [anti-PD-1/PD-L1] and before receiving a randomization number), of a tumor lesion not previously irradiated.
• Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose of study intervention but before randomization.
• Has a life expectancy of at least 3 months.
• Male participants receiving pembrolizumab ± lenvatinib or lenvatinib must agree to refrain from donating sperm, and either 1) be abstinent from heterosexual intercourse; or 2) follow contraceptive guidance during the treatment period or 7 days after the last dose of lenvatinib. Male participants receiving docetaxel agree to adhere to the same conditions during the treatment period and for ≥90 days after the last dose of study treatment.
• Female participants must not be pregnant, not be breastfeeding, and not be a woman of child-bearing potential (WOCBP). If a WOCBP, agrees to not donate eggs and either use contraception, or be abstinent from heterosexual intercourse during the treatment period and for ≥120 days after the last dose of pembrolizumab or 30 days after the last dose of lenvatinib, whichever occurs last. If a WOCBP receiving docetaxel, agrees to adhere to the same conditions during the treatment period and for ≥30 days after the last dose of study treatment.
• 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.
• If participant received major surgery or radiation therapy of >30 Gy, they have recovered from the toxicity and/or complications from the intervention.
• Has adequate organ function.

Exclusion Criteria

• Has received docetaxel as monotherapy or in combination with other therapies.
• Has received lenvatinib as monotherapy or in combination with an anti-PD-1/PD-L1 mAb.
• Has received: 1) radiotherapy within 2 weeks before the first dose of study treatment; or 2) lung radiation therapy >30 Gy within 6 months before the first dose of study treatment.
• Has received a live vaccine within 30 days before the first dose of study treatment.
• Has clinically significant hemoptysis or tumor bleeding within 2 weeks before the first dose of study treatment.
• Has radiographic evidence of intratumoral cavitation, encasement, or invasion of a major blood vessel.
• Has clinically significant cardiovascular impairment within 12 months of the first dose of study treatment.
• Has a history of a gastrointestinal condition or procedure that may affect oral absorption of study treatment.
• Has a pre-existing ≥Grade 3 gastrointestinal or non-gastrointestinal fistula.
• Is currently participating in a clinical trial and receiving study therapy or participated in a study of an investigational agent within 4 weeks of the first dose of study treatment.
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of study treatment.
• Has a known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of disease recurrence for 3 years since initiation of that therapy.
• Has known active central nervous system metastases and/or carcinomatous meningitis.
• Has severe hypersensitivity to pembrolizumab and/or any of its excipients.
• Has a sensitivity to any of the excipients contained in lenvatinib and/or docetaxel.
• Has an active autoimmune disease that has required systemic treatment in the past 2 years.
• Has a history of (noninfectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease.
• Has an active infection requiring systemic therapy.
• Has a known history of human immunodeficiency virus (HIV) infection.
• Has a known history of hepatitis B reactive or known active hepatitis C virus infection.
• Has active tuberculosis.
• Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
• Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through at least 120 days after the last dose of pembrolizumab or lenvatinib, or 90 days (male participants) or 30 days (for female participants) after the last dose of docetaxel.
• Has had an allogeneic tissue/solid organ transplant.

• 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

Comprehensive Blood & Cancer Center [Bakersfield, CA] ( Site 1604)

Bakersfield, California, United States

Cancer Specialists of North Florida - Fleming Island ( Site 1675)

Fleming Island, Florida, United States

Mid-Florida Cancer Centers ( Site 1611)

Orange City, Florida, United States

University of Kentucky School of Medicine & Hospitals ( Site 1621)

Lexington, Kentucky, United States

Hematology Oncology Clinic ( Site 1680)

Baton Rouge, Louisiana, United States

Harry & Jeanette Weinberg Cancer Institute ( Site 1626)

Baltimore, Maryland, United States

Medstar Good Samaritan Hospital ( Site 1625)

Baltimore, Maryland, United States

Massachusetts General Hospital ( Site 1622)

Boston, Massachusetts, United States

MGH - North Shore Cancer Center ( Site 1668)

Danvers, Massachusetts, United States

The Mass General Cancer Center at Newton-Wellesley ( Site 1692)

Newton, Massachusetts, United States

University of Massachusetts Medical School ( Site 1693)

Worcester, Massachusetts, United States

Billings Clinic ( Site 1631)

Billings, Montana, United States

Bozeman Health Deaconness Cancer Center ( Site 1632)

Bozeman, Montana, United States

Memorial Sloan-Kettering Cancer Center At Basking Ridge ( Site 1664)

Basking Ridge, New Jersey, United States

Memorial Sloan-Kettering Cancer Center at Middletown ( Site 1665)

Middletown, New Jersey, United States

Memorial Sloan-Kettering Cancer Center at Montvale ( Site 1667)

Montvale, New Jersey, United States

Memorial Sloan-Kettering Cancer Center at Commack ( Site 1662)

Commack, New York, United States

Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 1666)

Harrison, New York, United States

Memorial Sloan-Kettering Cancer Center ( Site 1661)

New York, New York, United States

New York Cancer and Blood Specialists ( Site 1696)

Port Jefferson Station, New York, United States

University of Rochester ( Site 1638)

Rochester, New York, United States

Memorial Sloan Kettering Cancer Center - Nassau ( Site 1670)

Uniondale, New York, United States

TriHealth Cancer Institute ( Site 1672)

Cincinnati, Ohio, United States

MetroHealth Medical Center ( Site 1694)

Cleveland, Ohio, United States

Kaiser Permanente Center for Health Research-Kaiser Permanente Medical Center ( Site 1644)

Portland, Oregon, United States

Fox Chase Cancer Center ( Site 1647)

Philadelphia, Pennsylvania, United States

Thompson Cancer Survival Center ( Site 1695)

Knoxville, Tennessee, United States

Millenium Physicians ( Site 1690)

Houston, Texas, United States

Instituto de Investigaciones Metabolicas ( Site 2004)

Caba, Buenos Aires, Argentina

Hospital Britanico de Buenos Aires ( Site 2002)

Buenos Aires, Buenos Aires F.D., Argentina

Sanatorio Parque ( Site 2005)

Rosario, Santa Fe Province, Argentina

Hospital Aleman ( Site 2000)

Buenos Aires, , Argentina

CEMIC ( Site 2003)

Buenos Aires, , Argentina

Blacktown Hospital ( Site 0004)

Blacktown, New South Wales, Australia

Port Macquarie Base Hospital ( Site 0003)

Port Macquarie, New South Wales, Australia

Westmead Hospital ( Site 0005)

Westmead, New South Wales, Australia

Southern Medical Day Care Centre ( Site 0001)

Wollongong, New South Wales, Australia

Princess Alexandra Hospital - Division of Cancer Services ( Site 0002)

Woolloongabba, Queensland, Australia

Calvary Central Districts Hospital ( Site 0007)

Elizabeth Vale, South Australia, Australia

Bendigo Cancer Centre ( Site 0008)

Bendigo, Victoria, Australia

CancerCare Manitoba ( Site 1504)

Winnipeg, Manitoba, Canada

Kingston Health Sciences Centre ( Site 1503)

Kingston, Ontario, Canada

London Regional Cancer Program - London HSC ( Site 1505)

London, Ontario, Canada

Princess Margaret Cancer Centre ( Site 1502)

Toronto, Ontario, Canada

CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 1501)

Montreal, Quebec, Canada

CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 1514)

Québec, Quebec, Canada

Rodrigo Botero SAS ( Site 1300)

Medellín, Antioquia, Colombia

Clinica de la Costa Ltda. ( Site 1309)

Barranquilla, Atlántico, Colombia

Administradora Country SA - Clinica del Country ( Site 1307)

Bogotá, Bogota D.C., Colombia

Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 1304)

Bogotá, Bogota D.C., Colombia

Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 1305)

Valledupar, Cesar Department, Colombia

Oncomedica S.A. ( Site 1302)

Montería, Departamento de Córdoba, Colombia

Centro Medico Imbanaco de Cali S.A ( Site 1301)

Cali, Valle del Cauca Department, Colombia

CHU Caen Service de Pneumologie ( Site 0401)

Caen, Calvados, France

HIA Percy-Clamart ( Site 0411)

Clamart, Hauts-de-Seine, France

ICO Centre Paul Papin ( Site 0412)

Angers, Maine-et-Loire, France

Clinique Ambroise Pare ( Site 0402)

Beuvry, Pas-de-Calais, France

Centre Hospitalier General - Avignon ( Site 0407)

Avignon, Provence-Alpes-Côte d'Azur Region, France

Centre Hospitalier Le Mans ( Site 0406)

Le Mans, Sarthe, France

Institut Curie ( Site 0400)

Paris, , France

Hopital Europeen Georges Pompidou ( Site 0408)

Paris, , France

Thoraxklinik Heidelberg gGmbH am Universitaetsklinikum Heidelberg ( Site 0501)

Heidelberg, Baden-Wurttemberg, Germany

Evangelisches Krankenhaus Hamm gGmbH ( Site 0504)

Hamm, North Rhine-Westphalia, Germany

SRH Wald-Klinikum Gera GmbH ( Site 0503)

Gera, Thuringia, Germany

Vivantes Klinikum Spandau ( Site 0505)

Berlin, , Germany

General Hospital of Chest Diseases "Sotiria" ( Site 1703)

Athens, Attica, Greece

Metropolitan Hospital-4th Oncology Dept ( Site 1700)

Athens, Attica, Greece

University Hospital of Ioannina ( Site 1701)

Ioannina, , Greece

European Interbalkan Medical Center ( Site 1704)

Thessaloniki, , Greece

Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház ( Site 0601)

Miskolc, Borsod-Abauj Zemplen county, Hungary

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 0606)

Székesfehérvár, Fejér, Hungary

Petz Aladar Megyei Oktato Korhaz ( Site 0609)

Győr, Győr-Moson-Sopron, Hungary

Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0610)

Szolnok, Jász-Nagykun-Szolnok, Hungary

Tudogyogyintezet Torokbalint ( Site 0602)

Törökbálint, Pest County, Hungary

Veszprem Megyei Tudogyogyintezet ( Site 0607)

Farkasgyepű, Veszprém megye, Hungary

Semmelweis Egyetem.. ( Site 0604)

Budapest, , Hungary

Orszagos Koranyi Pulmonologiai Intezet ( Site 0603)

Budapest, , Hungary

Orszagos Koranyi Pulmonologiai Intezet ( Site 0608)

Budapest, , Hungary

Soroka Medical Center ( Site 0701)

Beersheba, , Israel

Rambam Medical Center ( Site 0703)

Haifa, , Israel

Shaare Zedek Medical Center-Oncology ( Site 0706)

Jerusalem, , Israel

Meir Medical Center ( Site 0702)

Kfar Saba, , Israel

Rabin Medical Center ( Site 0700)

Petah Tikva, , Israel

Chaim Sheba Medical Center ( Site 0704)

Ramat Gan, , Israel

Sourasky Medical Center (Ichilov) - Oncology Clinic ( Site 0705)

Tel Aviv, , Israel

Ospedale San Gerardo - ASST Monza ( Site 0804)

Monza, Monza E Brianza, Italy

Istittuto Nazionale dei Tumori Regina Elena IRCCS - IFO ( Site 0807)

Rome, Roma, Italy

A.O. Ospedali Riuniti Villa Sofia - Cervello P.O. Villa Sofia ( Site 0810)

Palermo, Sicily, Italy

Ospedale San Luigi Gonzaga ( Site 0802)

Orbassano, Torino, Italy

Azienda Ospedaliera San Giuseppe Moscati ( Site 0809)

Avellino, , Italy

IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 0808)

Bari, , Italy

AOU Policlinico Vittorio Emanuele ( Site 0811)

Catania, , Italy

Istituto Nazionale dei Tumori ( Site 0806)

Milan, , Italy

Policlinico San Matteo - Fondazione IRCCS ( Site 0812)

Pavia, , Italy

Azienda Ospedaliera di Perugia ( Site 0805)

Perugia, , Italy

Kanagawa Cardiovascular and Respiratory Center ( Site 0105)

Yokohama, Kanagawa, Japan

Sendai Kousei Hospital ( Site 0107)

Sendai, Miyagi, Japan

Kansai Medical University Hospital ( Site 0104)

Hirakata, Osaka, Japan

Chiba University Hospital ( Site 0106)

Chiba, , Japan

Niigata Cancer Center Hospital ( Site 0101)

Niigata, , Japan

National Cancer Center Hospital ( Site 0103)

Tokyo, , Japan

The Cancer Institute Hospital of JFCR ( Site 0100)

Tokyo, , Japan

Centro Hospitalar Lisboa Norte E.P.E. - Hospital Pulido Valente ( Site 1801)

Lisbon, , Portugal

Hospital CUF Porto ( Site 1802)

Porto, , Portugal

Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 1800)

Porto, , Portugal

Hematology and Oncology Institute ( Site 2105)

Manatí, , Puerto Rico

Ad-Vance Medical Research LLC ( Site 2103)

Ponce, , Puerto Rico

Puerto Rico Medical Research Center LLC ( Site 2101)

San Juan, , Puerto Rico

GBUZ Republican Clinical Oncological Dispensary ( Site 0922)

Ufa, Baskortostan, Respublika, Russia

Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0918)

Krasnoyarsk, Krasnoyarsk Krai, Russia

Main Military Clinical Hospital n.a. N.N.Burdenko ( Site 0905)

Moscow, Moscow, Russia

Central Clinical Hospital of the Administration of the President ( Site 0910)

Moscow, Moscow, Russia

Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary-Chemotherapy #1 ( Site

Omsk, Omsk Oblast, Russia

Railway Hospital of OJSC ( Site 0907)

Saint Petersburg, Sankt-Peterburg, Russia

Pavlov First Saint Petersburg State Medical University ( Site 0917)

Saint Petersburg, Sankt-Peterburg, Russia

GBUZ SPb CRPCstmc(o) ( Site 0921)

Saint Petersburg, Sankt-Peterburg, Russia

Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0903)

Saint Petersburg, Sankt-Peterburg, Russia

SPb SBHI City Clinical Oncological Dispensary ( Site 0901)

Saint Petersburg, Sankt-Peterburg, Russia

Seoul National University Bundang Hospital ( Site 0204)

Seongnam-si, Kyonggi-do, South Korea

Chungbuk National University Hospital ( Site 0201)

Cheongju-si, North Chungcheong, South Korea

Asan Medical Center ( Site 0203)

Songpagu, Seoul, South Korea

Severance Hospital Yonsei University Health System ( Site 0202)

Seoul, , South Korea

Consorci Hospitalari Mataro ( Site 1008)

Mataró, Barcelona, Spain

Hospital Universitario Marques de Valdecilla ( Site 1003)

Santander, Cantabria, Spain

Hospital Universitario Insular de Gran Canaria ( Site 1011)

Las Palmas de Gran Canaria, Las Palmas, Spain

Hospital Universitario Puerta de Hierro ( Site 1007)

Majadahonda, Madrid, Spain

Hospital Universitario Quiron Madrid ( Site 1012)

Pozuelo de Alarcón, Madrid, Spain

Hospital Central de Asturias ( Site 1002)

Oviedo, Principality of Asturias, Spain

Hospital Clinico de Valencia ( Site 1010)

Valencia, Valenciana, Comunitat, Spain

Hospital Universitari Vall d Hebron ( Site 1004)

Barcelona, , Spain

Hospital Ciudad de Jaen ( Site 1000)

Jaén, , Spain

Hospital Universitario Fundacion Jimenez Diaz ( Site 1005)

Madrid, , Spain

Hospital Universitario 12 de Octubre ( Site 1006)

Madrid, , Spain

Hull & East Yorkshire NHS Trust. Castle Hill Hospital ( Site 1108)

Cottingham, East Riding Of Yorkshire, United Kingdom

Nottingham City Hospital Campus ( Site 1105)

Nottingham, England, United Kingdom

Leicester Royal Infirmary ( Site 1110)

Leicester, Leicestershire, United Kingdom

North Middlesex University Hospital NHS Trust ( Site 1109)

London, London, City of, United Kingdom

Guy s and St Thomas Hospital NHS Foundation Trust ( Site 1102)

London, London, City of, United Kingdom

Mount Vernon Cancer Centre ( Site 1107)

Northwood, London, City of, United Kingdom

Aberdeen Royal Infirmary ( Site 1114)

Aberdeen, Scotland, United Kingdom

University Hospital Coventry and Warwickshire NHS Trust ( Site 1112)

Coventry, Warwickshire, United Kingdom

Birmingham Heartlands Hospital ( Site 1103)

Birmingham, , United Kingdom

St James s University Hospital ( Site 1106)

Leeds, , United Kingdom

Countries

United States; Argentina; Australia; Canada; Colombia; France; Germany; Greece; Hungary; Israel; Italy; Japan; Portugal; Puerto Rico; Russia; South Korea; Spain; United Kingdom

References

Leighl NB, Paz-Ares L, Abreu DR, Hui R, Baka S, Bigot F, Nishio M, Smolin A, Ahmed S, Schoenfeld AJ, Daher S, Cortinovis DL, Di Noia V, Linardou H, Gainor JF, Dutcus C, Okpara CE, Deng X, Kush D, Arunachalam A, Song A, Cho BC. LEAP-008: Lenvatinib Plus Pembrolizumab for Metastatic NSCLC That Has Progressed After an Anti-Programmed Cell Death Protein 1 or Anti-Programmed Cell Death Ligand 1 Plus Platinum Chemotherapy. J Thorac Oncol. 2025 Oct;20(10):1489-1504. doi: 10.1016/j.jtho.2025.05.020. Epub 2025 Jun 3.

Reference Type: RESULT

PMID: 40473109 (View on PubMed)

Xing P, Wang M, Zhao J, Zhong W, Chi Y, Xu Z, Li J. Study protocol: A single-arm, multicenter, phase II trial of camrelizumab plus apatinib for advanced nonsquamous NSCLC previously treated with first-line immunotherapy. Thorac Cancer. 2021 Oct;12(20):2825-2828. doi: 10.1111/1759-7714.14113. Epub 2021 Aug 18.

Reference Type: DERIVED

PMID: 34409776 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33300372 (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

https://msd.trialsummaries.com/Study/StudyDetails?id=26246&tenant=MT_MSD_9011

Plain Language Summary

Other Identifiers

MK-7902-008

Identifier Type: OTHER

Identifier Source: secondary_id

LEAP-008

Identifier Type: OTHER

Identifier Source: secondary_id

E7080-G000-316

Identifier Type: OTHER

Identifier Source: secondary_id

195003

Identifier Type: REGISTRY

Identifier Source: secondary_id

2022-501439-18-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1280-4337

Identifier Type: REGISTRY

Identifier Source: secondary_id

2018-003791-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

7902-008

Identifier Type: -

Identifier Source: org_study_id