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 | Completed Phase 3 Results DMC FDA Drug

• 8 other identifiers: 7902-008MK-7902-008LEAP-008E7080-G000-3161950032022-501439-18-00U1111-1280-43372018-003791-12
• Study Type: interventional
• Target: 422
• Locations: 18 countries
• Sites: 143

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

Keywords

programmed cell death 1 (PD-1, PD1); programmed cell death-ligand 1 (PD-L1, PDL1); programmed cell death-ligand 2 (PD-L2, PDL2)

Outcome Measures

Primary Outcomes (2)

• Overall Survival (OS)

  OS is defined as the time from randomization to the date of death due to any cause.

  Up to ~47 months

• Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

  PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is 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 is also considered PD. PFS was assessed by blinded independent central review (BICR) per RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.

  Up to ~47 months

Secondary Outcomes (16)

• Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+Lenvatinib vs. Docetaxel

  Up to ~47 months

• Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+Lenvatinib vs. Lenvatinib Monotherapy

  Up to ~47 months

• Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

  Up to ~47 months

• Number of Participants Experiencing an Adverse Event (AE)

  Up to ~47 months

• Number of Participants Discontinuing Study Treatment Due to an AE

  Up to ~47 months

Study Arms (3)

Pembrolizumab+Lenvatinib

EXPERIMENTAL

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.

Biological: Pembrolizumab; Drug: Lenvatinib

Docetaxel

ACTIVE COMPARATOR

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.

Drug: Docetaxel

Lenvatinib Monotherapy

EXPERIMENTAL

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

Drug: Lenvatinib

Interventions

Pembrolizumab BIOLOGICAL

IV infusion of pembrolizumab at 200 mg

Also known as: MK-3475, KEYTRUDA®

Pembrolizumab+Lenvatinib

Lenvatinib DRUG

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

Also known as: MK-7902, E7080, LENVIMA®

Lenvatinib Monotherapy; Pembrolizumab+Lenvatinib

Docetaxel DRUG

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

Also known as: TAXOTERE®

Docetaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• Eisai Inc.: collaborator

Study Sites (143)

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

Bakersfield, California, 93309, United States

Location

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

Fleming Island, Florida, 32003, United States

Location

Mid-Florida Cancer Centers ( Site 1611)

Orange City, Florida, 32763, United States

Location

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

Lexington, Kentucky, 40536, United States

Location

Hematology Oncology Clinic ( Site 1680)

Baton Rouge, Louisiana, 70809, United States

Location

Harry & Jeanette Weinberg Cancer Institute ( Site 1626)

Baltimore, Maryland, 21237, United States

Location

Medstar Good Samaritan Hospital ( Site 1625)

Baltimore, Maryland, 21239, United States

Location

Massachusetts General Hospital ( Site 1622)

Boston, Massachusetts, 02114, United States

Location

MGH - North Shore Cancer Center ( Site 1668)

Danvers, Massachusetts, 01923, United States

Location

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

Newton, Massachusetts, 02462, United States

Location

University of Massachusetts Medical School ( Site 1693)

Worcester, Massachusetts, 01655, United States

Location

Billings Clinic ( Site 1631)

Billings, Montana, 59101, United States

Location

Bozeman Health Deaconness Cancer Center ( Site 1632)

Bozeman, Montana, 59715, United States

Location

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

Basking Ridge, New Jersey, 07920, United States

Location

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

Middletown, New Jersey, 07748, United States

Location

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

Montvale, New Jersey, 07645, United States

Location

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

Commack, New York, 11725, United States

Location

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

Harrison, New York, 10604, United States

Location

Memorial Sloan-Kettering Cancer Center ( Site 1661)

New York, New York, 10065, United States

Location

New York Cancer and Blood Specialists ( Site 1696)

Port Jefferson Station, New York, 11776, United States

Location

University of Rochester ( Site 1638)

Rochester, New York, 14642, United States

Location

Memorial Sloan Kettering Cancer Center - Nassau ( Site 1670)

Uniondale, New York, 11553, United States

Location

TriHealth Cancer Institute ( Site 1672)

Cincinnati, Ohio, 45220, United States

Location

MetroHealth Medical Center ( Site 1694)

Cleveland, Ohio, 44109, United States

Location

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

Portland, Oregon, 97227, United States

Location

Fox Chase Cancer Center ( Site 1647)

Philadelphia, Pennsylvania, 19111, United States

Location

Thompson Cancer Survival Center ( Site 1695)

Knoxville, Tennessee, 37916, United States

Location

Millenium Physicians ( Site 1690)

Houston, Texas, 77090, United States

Location

Instituto de Investigaciones Metabolicas ( Site 2004)

Caba, Buenos Aires, C1012AAR, Argentina

Location

Hospital Britanico de Buenos Aires ( Site 2002)

Buenos Aires, Buenos Aires F.D., C1280AEB, Argentina

Location

Sanatorio Parque ( Site 2005)

Rosario, Santa Fe Province, S2000DSV, Argentina

Location

Hospital Aleman ( Site 2000)

Buenos Aires, C1118AAT, Argentina

Location

CEMIC ( Site 2003)

Buenos Aires, C1431FWO, Argentina

Location

Blacktown Hospital ( Site 0004)

Blacktown, New South Wales, 2148, Australia

Location

Port Macquarie Base Hospital ( Site 0003)

Port Macquarie, New South Wales, 2444, Australia

Location

Westmead Hospital ( Site 0005)

Westmead, New South Wales, 2145, Australia

Location

Southern Medical Day Care Centre ( Site 0001)

Wollongong, New South Wales, 2500, Australia

Location

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

Woolloongabba, Queensland, 4102, Australia

Location

Calvary Central Districts Hospital ( Site 0007)

Elizabeth Vale, South Australia, 5112, Australia

Location

Bendigo Cancer Centre ( Site 0008)

Bendigo, Victoria, 3552, Australia

Location

CancerCare Manitoba ( Site 1504)

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Kingston Health Sciences Centre ( Site 1503)

Kingston, Ontario, K7L 2V7, Canada

Location

London Regional Cancer Program - London HSC ( Site 1505)

London, Ontario, N6A 5W9, Canada

Location

Princess Margaret Cancer Centre ( Site 1502)

Toronto, Ontario, M5G 2M9, Canada

Location

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

Montreal, Quebec, H3T 1M5, Canada

Location

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

Québec, Quebec, G1R 2J6, Canada

Location

Rodrigo Botero SAS ( Site 1300)

Medellín, Antioquia, 050030, Colombia

Location

Clinica de la Costa Ltda. ( Site 1309)

Barranquilla, Atlántico, 080020, Colombia

Location

Administradora Country SA - Clinica del Country ( Site 1307)

Bogotá, Bogota D.C., 110221, Colombia

Location

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

Bogotá, Bogota D.C., 110311, Colombia

Location

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

Valledupar, Cesar Department, 200001, Colombia

Location

Oncomedica S.A. ( Site 1302)

Montería, Departamento de Córdoba, 230001, Colombia

Location

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

Cali, Valle del Cauca Department, 760042, Colombia

Location

CHU Caen Service de Pneumologie ( Site 0401)

Caen, Calvados, 14033, France

Location

HIA Percy-Clamart ( Site 0411)

Clamart, Hauts-de-Seine, 92140, France

Location

ICO Centre Paul Papin ( Site 0412)

Angers, Maine-et-Loire, 49100, France

Location

Clinique Ambroise Pare ( Site 0402)

Beuvry, Pas-de-Calais, 62660, France

Location

Centre Hospitalier General - Avignon ( Site 0407)

Avignon, Provence-Alpes-Côte d'Azur Region, 84000, France

Location

Centre Hospitalier Le Mans ( Site 0406)

Le Mans, Sarthe, 72037, France

Location

Institut Curie ( Site 0400)

Paris, 75005, France

Location

Hopital Europeen Georges Pompidou ( Site 0408)

Paris, 75015, France

Location

Thoraxklinik Heidelberg gGmbH am Universitaetsklinikum Heidelberg ( Site 0501)

Heidelberg, Baden-Wurttemberg, 69126, Germany

Location

Evangelisches Krankenhaus Hamm gGmbH ( Site 0504)

Hamm, North Rhine-Westphalia, 59063, Germany

Location

SRH Wald-Klinikum Gera GmbH ( Site 0503)

Gera, Thuringia, 07548, Germany

Location

Vivantes Klinikum Spandau ( Site 0505)

Berlin, 13585, Germany

Location

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

Athens, Attica, 115 27, Greece

Location

Metropolitan Hospital-4th Oncology Dept ( Site 1700)

Athens, Attica, 185 47, Greece

Location

University Hospital of Ioannina ( Site 1701)

Ioannina, 455 00, Greece

Location

European Interbalkan Medical Center ( Site 1704)

Thessaloniki, 570 01, Greece

Location

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

Miskolc, Borsod-Abauj Zemplen county, 3526, Hungary

Location

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 0606)

Székesfehérvár, Fejér, 8000, Hungary

Location

Petz Aladar Megyei Oktato Korhaz ( Site 0609)

Győr, Győr-Moson-Sopron, 9024, Hungary

Location

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

Szolnok, Jász-Nagykun-Szolnok, 5004, Hungary

Location

Tudogyogyintezet Torokbalint ( Site 0602)

Törökbálint, Pest County, 2045, Hungary

Location

Veszprem Megyei Tudogyogyintezet ( Site 0607)

Farkasgyepű, Veszprém megye, 8582, Hungary

Location

Semmelweis Egyetem.. ( Site 0604)

Budapest, 1083, Hungary

Location

Orszagos Koranyi Pulmonologiai Intezet ( Site 0603)

Budapest, 1121, Hungary

Location

Orszagos Koranyi Pulmonologiai Intezet ( Site 0608)

Budapest, 1121, Hungary

Location

Soroka Medical Center ( Site 0701)

Beersheba, 8410101, Israel

Location

Rambam Medical Center ( Site 0703)

Haifa, 3525408, Israel

Location

Shaare Zedek Medical Center-Oncology ( Site 0706)

Jerusalem, 9013102, Israel

Location

Meir Medical Center ( Site 0702)

Kfar Saba, 4428132, Israel

Location

Rabin Medical Center ( Site 0700)

Petah Tikva, 4941492, Israel

Location

Chaim Sheba Medical Center ( Site 0704)

Ramat Gan, 5262000, Israel

Location

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

Tel Aviv, 6423906, Israel

Location

Ospedale San Gerardo - ASST Monza ( Site 0804)

Monza, Monza E Brianza, 20900, Italy

Location

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

Rome, Roma, 00144, Italy

Location

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

Palermo, Sicily, 90146, Italy

Location

Ospedale San Luigi Gonzaga ( Site 0802)

Orbassano, Torino, 10043, Italy

Location

Azienda Ospedaliera San Giuseppe Moscati ( Site 0809)

Avellino, 83100, Italy

Location

IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 0808)

Bari, 70124, Italy

Location

AOU Policlinico Vittorio Emanuele ( Site 0811)

Catania, 95123, Italy

Location

Istituto Nazionale dei Tumori ( Site 0806)

Milan, 20133, Italy

Location

Policlinico San Matteo - Fondazione IRCCS ( Site 0812)

Pavia, 27100, Italy

Location

Azienda Ospedaliera di Perugia ( Site 0805)

Perugia, 06132, Italy

Location

Kanagawa Cardiovascular and Respiratory Center ( Site 0105)

Yokohama, Kanagawa, 236-0051, Japan

Location

Sendai Kousei Hospital ( Site 0107)

Sendai, Miyagi, 980-0873, Japan

Location

Kansai Medical University Hospital ( Site 0104)

Hirakata, Osaka, 573-1191, Japan

Location

Chiba University Hospital ( Site 0106)

Chiba, 260-8677, Japan

Location

Niigata Cancer Center Hospital ( Site 0101)

Niigata, 951-8566, Japan

Location

National Cancer Center Hospital ( Site 0103)

Tokyo, 104-0045, Japan

Location

The Cancer Institute Hospital of JFCR ( Site 0100)

Tokyo, 135-8550, Japan

Location

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

Lisbon, 1769-001, Portugal

Location

Hospital CUF Porto ( Site 1802)

Porto, 4100-180, Portugal

Location

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

Porto, 4200-072, Portugal

Location

Hematology and Oncology Institute ( Site 2105)

Manatí, 00674, Puerto Rico

Location

Ad-Vance Medical Research LLC ( Site 2103)

Ponce, 00717, Puerto Rico

Location

Puerto Rico Medical Research Center LLC ( Site 2101)

San Juan, 00918, Puerto Rico

Location

GBUZ Republican Clinical Oncological Dispensary ( Site 0922)

Ufa, Baskortostan, Respublika, 450054, Russia

Location

Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0918)

Krasnoyarsk, Krasnoyarsk Krai, 660133, Russia

Location

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

Moscow, Moscow, 105094, Russia

Location

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

Moscow, Moscow, 121359, Russia

Location

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

Omsk, Omsk Oblast, 644013, Russia

Location

Railway Hospital of OJSC ( Site 0907)

Saint Petersburg, Sankt-Peterburg, 195271, Russia

Location

Pavlov First Saint Petersburg State Medical University ( Site 0917)

Saint Petersburg, Sankt-Peterburg, 197022, Russia

Location

GBUZ SPb CRPCstmc(o) ( Site 0921)

Saint Petersburg, Sankt-Peterburg, 197758, Russia

Location

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

Saint Petersburg, Sankt-Peterburg, 197758, Russia

Location

SPb SBHI City Clinical Oncological Dispensary ( Site 0901)

Saint Petersburg, Sankt-Peterburg, 198255, Russia

Location

Seoul National University Bundang Hospital ( Site 0204)

Seongnam-si, Kyonggi-do, 13620, South Korea

Location

Chungbuk National University Hospital ( Site 0201)

Cheongju-si, North Chungcheong, 28644, South Korea

Location

Asan Medical Center ( Site 0203)

Songpagu, Seoul, 05505, South Korea

Location

Severance Hospital Yonsei University Health System ( Site 0202)

Seoul, 03722, South Korea

Location

Consorci Hospitalari Mataro ( Site 1008)

Mataró, Barcelona, 08304, Spain

Location

Hospital Universitario Marques de Valdecilla ( Site 1003)

Santander, Cantabria, 39008, Spain

Location

Hospital Universitario Insular de Gran Canaria ( Site 1011)

Las Palmas de Gran Canaria, Las Palmas, 35001, Spain

Location

Hospital Universitario Puerta de Hierro ( Site 1007)

Majadahonda, Madrid, 28222, Spain

Location

Hospital Universitario Quiron Madrid ( Site 1012)

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Hospital Central de Asturias ( Site 1002)

Oviedo, Principality of Asturias, 33011, Spain

Location

Hospital Clinico de Valencia ( Site 1010)

Valencia, Valenciana, Comunitat, 46010, Spain

Location

Hospital Universitari Vall d Hebron ( Site 1004)

Barcelona, 08035, Spain

Location

Hospital Ciudad de Jaen ( Site 1000)

Jaén, 23007, Spain

Location

Hospital Universitario Fundacion Jimenez Diaz ( Site 1005)

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre ( Site 1006)

Madrid, 28041, Spain

Location

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

Cottingham, East Riding Of Yorkshire, HU16 5JQ, United Kingdom

Location

Nottingham City Hospital Campus ( Site 1105)

Nottingham, England, NG5 1PB, United Kingdom

Location

Leicester Royal Infirmary ( Site 1110)

Leicester, Leicestershire, LE1 5WW, United Kingdom

Location

North Middlesex University Hospital NHS Trust ( Site 1109)

London, London, City of, N18 1QX, United Kingdom

Location

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

London, London, City of, SE1 9RT, United Kingdom

Location

Mount Vernon Cancer Centre ( Site 1107)

Northwood, London, City of, HA6 2RN, United Kingdom

Location

Aberdeen Royal Infirmary ( Site 1114)

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

University Hospital Coventry and Warwickshire NHS Trust ( Site 1112)

Coventry, Warwickshire, CV2 2DX, United Kingdom

Location

Birmingham Heartlands Hospital ( Site 1103)

Birmingham, B9 5SS, United Kingdom

Location

St James s University Hospital ( Site 1106)

Leeds, LS9 7TF, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 40473109 RESULT

• 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.

  PMID: 34409776 DERIVED

• 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.

  PMID: 33300372 DERIVED

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Parkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

pembrolizumab; lenvatinib; Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: June 6, 2019
• Study Start: June 26, 2019
• Primary Completion: August 11, 2023
• Study Completion: August 22, 2024
• Last Updated: August 15, 2025
• Results First Posted: August 22, 2024

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

FR (8); AU (7); HU (9); IT (10); AR (5); CA (6); US (28); DE (4); GB (10); KR (4); JP (7); GR (4); RU (10); PR (3); CO (7); PT (3); IL (7); ES (11)