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)

July 30, 2025 updated by: Merck Sharp & Dohme LLC

A Phase 3, Multicenter, Randomized, Open-label Trial to Compare the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Lenvatinib (E7080/MK-7902) Versus Docetaxel in Previously Treated Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) and Progressive Disease (PD) After Platinum Doublet Chemotherapy and Immunotherapy (LEAP-008)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

422

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1118AAT
        • Hospital Aleman ( Site 2000)
      • Buenos Aires, Argentina, C1431FWO
        • CEMIC ( Site 2003)
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1012AAR
        • Instituto de Investigaciones Metabolicas ( Site 2004)
    • Caba
      • Buenos Aires, Caba, Argentina, C1280AEB
        • Hospital Britanico de Buenos Aires ( Site 2002)
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000DSV
        • Sanatorio Parque ( Site 2005)
  • Australia
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
        • Blacktown Hospital ( Site 0004)
      • Port Macquarie, New South Wales, Australia, 2444
        • Port Macquarie Base Hospital ( Site 0003)
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital ( Site 0005)
      • Wollongong, New South Wales, Australia, 2500
        • Southern Medical Day Care Centre ( Site 0001)
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital - Division of Cancer Services ( Site 0002)
    • South Australia
      • Elizabeth Vale, South Australia, Australia, 5112
        • Calvary Central Districts Hospital ( Site 0007)
    • Victoria
      • Bendigo, Victoria, Australia, 3552
        • Bendigo Cancer Centre ( Site 0008)
  • Canada
      • Quebec, Canada, G1R 2J6
        • CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 1514)
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • CancerCare Manitoba ( Site 1504)
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • Kingston Health Sciences Centre ( Site 1503)
      • London, Ontario, Canada, N6A 5W9
        • London Regional Cancer Program - London HSC ( Site 1505)
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre ( Site 1502)
    • Quebec
      • Montreal, Quebec, Canada, H3T 1M5
        • CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 1501)
  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia, 050030
        • Rodrigo Botero SAS ( Site 1300)
    • Atlantico
      • Barranquilla, Atlantico, Colombia, 080020
        • Clinica de la Costa Ltda. ( Site 1309)
    • Cesar
      • Valledupar, Cesar, Colombia, 200001
        • Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 1305)
    • Cordoba
      • Monteria, Cordoba, Colombia, 230001
        • Oncomedica S.A. ( Site 1302)
    • Distrito Capital De Bogota
      • Bogota, Distrito Capital De Bogota, Colombia, 110221
        • Administradora Country SA - Clinica del Country ( Site 1307)
      • Bogota, Distrito Capital De Bogota, Colombia, 110311
        • Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 1304)
    • Valle Del Cauca
      • Cali, Valle Del Cauca, Colombia, 760042
        • Centro Medico Imbanaco de Cali S.A ( Site 1301)
  • France
      • Paris, France, 75005
        • Institut Curie ( Site 0400)
      • Paris, France, 75015
        • Hopital Europeen Georges Pompidou ( Site 0408)
    • Calvados
      • Caen, Calvados, France, 14033
        • CHU Caen Service de Pneumologie ( Site 0401)
    • Hauts-de-Seine
      • Clamart, Hauts-de-Seine, France, 92140
        • HIA Percy-Clamart ( Site 0411)
    • Maine-et-Loire
      • Angers, Maine-et-Loire, France, 49100
        • ICO Centre Paul Papin ( Site 0412)
    • Pas-de-Calais
      • Beuvry, Pas-de-Calais, France, 62660
        • Clinique Ambroise Pare ( Site 0402)
    • Provence-Alpes-Cote-d Azur
      • Avignon, Provence-Alpes-Cote-d Azur, France, 84000
        • Centre Hospitalier General - Avignon ( Site 0407)
    • Sarthe
      • Le Mans, Sarthe, France, 72037
        • Centre Hospitalier Le Mans ( Site 0406)
  • Germany
      • Berlin, Germany, 13585
        • Vivantes Klinikum Spandau ( Site 0505)
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Germany, 69126
        • Thoraxklinik Heidelberg gGmbH am Universitaetsklinikum Heidelberg ( Site 0501)
    • Nordrhein-Westfalen
      • Hamm, Nordrhein-Westfalen, Germany, 59063
        • Evangelisches Krankenhaus Hamm gGmbH ( Site 0504)
    • Thuringen
      • Gera, Thuringen, Germany, 07548
        • SRH Wald-Klinikum Gera GmbH ( Site 0503)
  • Greece
      • Ioannina, Greece, 455 00
        • University Hospital of Ioannina ( Site 1701)
      • Thessaloniki, Greece, 570 01
        • European Interbalkan Medical Center ( Site 1704)
    • Attiki
      • Athens, Attiki, Greece, 115 27
        • General Hospital of Chest Diseases "Sotiria" ( Site 1703)
      • Athens, Attiki, Greece, 185 47
        • Metropolitan Hospital-4th Oncology Dept ( Site 1700)
  • Hungary
      • Budapest, Hungary, 1083
        • Semmelweis Egyetem.. ( Site 0604)
      • Budapest, Hungary, 1121
        • Orszagos Koranyi Pulmonologiai Intezet ( Site 0603)
      • Budapest, Hungary, 1121
        • Orszagos Koranyi Pulmonologiai Intezet ( Site 0608)
    • Borsod-Abauj-Zemplen
      • Miskolc, Borsod-Abauj-Zemplen, Hungary, 3526
        • Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház ( Site 0601)
    • Fejer
      • Szekesfehervar, Fejer, Hungary, 8000
        • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 0606)
    • Gyor-Moson-Sopron
      • Gyor, Gyor-Moson-Sopron, Hungary, 9024
        • Petz Aladar Megyei Oktato Korhaz ( Site 0609)
    • Jasz-Nagykun-Szolnok
      • Szolnok, Jasz-Nagykun-Szolnok, Hungary, 5004
        • Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0610)
    • Pest
      • Torokbalint, Pest, Hungary, 2045
        • Tudogyogyintezet Torokbalint ( Site 0602)
    • Veszprem
      • Farkasgyepu, Veszprem, Hungary, 8582
        • Veszprem Megyei Tudogyogyintezet ( Site 0607)
  • Israel
      • Beer Sheva, Israel, 8410101
        • Soroka Medical Center ( Site 0701)
      • Haifa, Israel, 3525408
        • Rambam Medical Center ( Site 0703)
      • Jerusalem, Israel, 9013102
        • Shaare Zedek Medical Center-Oncology ( Site 0706)
      • Kfar-Saba, Israel, 4428132
        • Meir Medical Center ( Site 0702)
      • Petah Tikva, Israel, 4941492
        • Rabin Medical Center ( Site 0700)
      • Ramat Gan, Israel, 5262000
        • Chaim Sheba Medical Center ( Site 0704)
      • Tel Aviv, Israel, 6423906
        • Sourasky Medical Center (Ichilov) - Oncology Clinic ( Site 0705)
  • Italy
      • Avellino, Italy, 83100
        • Azienda Ospedaliera San Giuseppe Moscati ( Site 0809)
      • Bari, Italy, 70124
        • IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 0808)
      • Catania, Italy, 95123
        • AOU Policlinico Vittorio Emanuele ( Site 0811)
      • Milano, Italy, 20133
        • Istituto Nazionale dei Tumori ( Site 0806)
      • Pavia, Italy, 27100
        • Policlinico San Matteo - Fondazione IRCCS ( Site 0812)
      • Perugia, Italy, 06132
        • Azienda Ospedaliera di Perugia ( Site 0805)
    • Monza E Brianza
      • Monza, Monza E Brianza, Italy, 20900
        • Ospedale San Gerardo - ASST Monza ( Site 0804)
    • Roma
      • Rome, Roma, Italy, 00144
        • Istittuto Nazionale dei Tumori Regina Elena IRCCS - IFO ( Site 0807)
    • Sicilia
      • Palermo, Sicilia, Italy, 90146
        • A.O. Ospedali Riuniti Villa Sofia - Cervello P.O. Villa Sofia ( Site 0810)
    • Torino
      • Orbassano, Torino, Italy, 10043
        • Ospedale San Luigi Gonzaga ( Site 0802)
  • Japan
      • Chiba, Japan, 260-8677
        • Chiba University Hospital ( Site 0106)
      • Niigata, Japan, 951-8566
        • Niigata Cancer Center Hospital ( Site 0101)
      • Tokyo, Japan, 104-0045
        • National Cancer Center Hospital ( Site 0103)
      • Tokyo, Japan, 135-8550
        • The Cancer Institute Hospital of JFCR ( Site 0100)
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 236-0051
        • Kanagawa Cardiovascular and Respiratory Center ( Site 0105)
    • Miyagi
      • Sendai, Miyagi, Japan, 980-0873
        • Sendai Kousei Hospital ( Site 0107)
    • Osaka
      • Hirakata, Osaka, Japan, 573-1191
        • Kansai Medical University Hospital ( Site 0104)
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital Yonsei University Health System ( Site 0202)
    • Chungbuk
      • Cheongju si, Chungbuk, Korea, Republic of, 28644
        • Chungbuk National University Hospital ( Site 0201)
    • Kyonggi-do
      • Seongnam-si, Kyonggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital ( Site 0204)
    • Seoul
      • Songpagu, Seoul, Korea, Republic of, 05505
        • Asan Medical Center ( Site 0203)
  • Portugal
      • Lisboa, Portugal, 1769-001
        • Centro Hospitalar Lisboa Norte E.P.E. - Hospital Pulido Valente ( Site 1801)
      • Porto, Portugal, 4100-180
        • Hospital CUF Porto ( Site 1802)
      • Porto, Portugal, 4200-072
        • Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 1800)
  • Puerto Rico
      • Manati, Puerto Rico, 00674
        • Hematology and Oncology Institute ( Site 2105)
      • Ponce, Puerto Rico, 00717
        • Ad-Vance Medical Research LLC ( Site 2103)
      • San Juan, Puerto Rico, 00918
        • Puerto Rico Medical Research Center LLC ( Site 2101)
  • Russian Federation
    • Baskortostan, Respublika
      • Ufa, Baskortostan, Respublika, Russian Federation, 450054
        • GBUZ Republican Clinical Oncological Dispensary ( Site 0922)
    • Krasnoyarskiy Kray
      • Krasnoyarsk, Krasnoyarskiy Kray, Russian Federation, 660133
        • Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0918)
    • Moskva
      • Moscow, Moskva, Russian Federation, 105094
        • Main Military Clinical Hospital n.a. N.N.Burdenko ( Site 0905)
      • Moscow, Moskva, Russian Federation, 121359
        • Central Clinical Hospital of the Administration of the President ( Site 0910)
    • Omskaya Oblast
      • Omsk, Omskaya Oblast, Russian Federation, 644013
        • Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary-Chemotherapy #1 ( Site
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russian Federation, 198255
        • SPb SBHI City Clinical Oncological Dispensary ( Site 0901)
      • Saint-Petersburg, Sankt-Peterburg, Russian Federation, 195271
        • Railway Hospital of OJSC ( Site 0907)
      • Saint-Petersburg, Sankt-Peterburg, Russian Federation, 197758
        • Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0903)
      • Sankt- Peterburg, Sankt-Peterburg, Russian Federation, 197758
        • GBUZ SPb CRPCstmc(o) ( Site 0921)
      • St. Petersburg, Sankt-Peterburg, Russian Federation, 197022
        • Pavlov First Saint Petersburg State Medical University ( Site 0917)
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d Hebron ( Site 1004)
      • Jaen, Spain, 23007
        • Hospital Ciudad de Jaen ( Site 1000)
      • Madrid, Spain, 28040
        • Hospital Universitario Fundacion Jimenez Diaz ( Site 1005)
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre ( Site 1006)
    • Asturias
      • Oviedo, Asturias, Spain, 33011
        • Hospital Central de Asturias ( Site 1002)
    • Barcelona
      • Mataro, Barcelona, Spain, 08304
        • Consorci Hospitalari Mataro ( Site 1008)
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Universitario Marques de Valdecilla ( Site 1003)
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spain, 35001
        • Hospital Universitario Insular de Gran Canaria ( Site 1011)
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro ( Site 1007)
      • Pozuelo de Alarcon, Madrid, Spain, 28223
        • Hospital Universitario Quiron Madrid ( Site 1012)
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spain, 46010
        • Hospital Clinico de Valencia ( Site 1010)
  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Birmingham Heartlands Hospital ( Site 1103)
      • Leeds, United Kingdom, LS9 7TF
        • St James s University Hospital ( Site 1106)
    • East Riding Of Yorkshire
      • Cottingham, East Riding Of Yorkshire, United Kingdom, HU16 5JQ
        • Hull & East Yorkshire NHS Trust. Castle Hill Hospital ( Site 1108)
    • England
      • Nottingham, England, United Kingdom, NG5 1PB
        • Nottingham City Hospital Campus ( Site 1105)
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom, LE1 5WW
        • Leicester Royal Infirmary ( Site 1110)
    • London, City Of
      • London, London, City Of, United Kingdom, N18 1QX
        • North Middlesex University Hospital NHS Trust ( Site 1109)
      • London, London, City Of, United Kingdom, SE1 9RT
        • Guy s and St Thomas Hospital NHS Foundation Trust ( Site 1102)
      • Northwood, London, City Of, United Kingdom, HA6 2RN
        • Mount Vernon Cancer Centre ( Site 1107)
    • Scotland
      • Aberdeen, Scotland, United Kingdom, AB25 2ZN
        • Aberdeen Royal Infirmary ( Site 1114)
    • Warwickshire
      • Coventry, Warwickshire, United Kingdom, CV2 2DX
        • University Hospital Coventry and Warwickshire NHS Trust ( Site 1112)
  • United States
    • California
      • Bakersfield, California, United States, 93309
        • Comprehensive Blood & Cancer Center [Bakersfield, CA] ( Site 1604)
    • Florida
      • Fleming Island, Florida, United States, 32003
        • Cancer Specialists of North Florida - Fleming Island ( Site 1675)
      • Orange City, Florida, United States, 32763
        • Mid-Florida Cancer Centers ( Site 1611)
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky School of Medicine & Hospitals ( Site 1621)
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Hematology Oncology Clinic ( Site 1680)
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • Harry & Jeanette Weinberg Cancer Institute ( Site 1626)
      • Baltimore, Maryland, United States, 21239
        • Medstar Good Samaritan Hospital ( Site 1625)
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital ( Site 1622)
      • Danvers, Massachusetts, United States, 01923
        • MGH - North Shore Cancer Center ( Site 1668)
      • Newton, Massachusetts, United States, 02462
        • The Mass General Cancer Center at Newton-Wellesley ( Site 1692)
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Medical School ( Site 1693)
    • Montana
      • Billings, Montana, United States, 59101
        • Billings Clinic ( Site 1631)
      • Bozeman, Montana, United States, 59715
        • Bozeman Health Deaconness Cancer Center ( Site 1632)
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Memorial Sloan-Kettering Cancer Center At Basking Ridge ( Site 1664)
      • Middletown, New Jersey, United States, 07748
        • Memorial Sloan-Kettering Cancer Center at Middletown ( Site 1665)
      • Montvale, New Jersey, United States, 07645
        • Memorial Sloan-Kettering Cancer Center at Montvale ( Site 1667)
    • New York
      • Commack, New York, United States, 11725
        • Memorial Sloan-Kettering Cancer Center at Commack ( Site 1662)
      • Harrison, New York, United States, 10604
        • Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 1666)
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer Center ( Site 1661)
      • Port Jefferson Station, New York, United States, 11776
        • New York Cancer and Blood Specialists ( Site 1696)
      • Rochester, New York, United States, 14642
        • University of Rochester ( Site 1638)
      • Uniondale, New York, United States, 11553
        • Memorial Sloan Kettering Cancer Center - Nassau ( Site 1670)
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • TriHealth Cancer Institute ( Site 1672)
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center ( Site 1694)
    • Oregon
      • Portland, Oregon, United States, 97227
        • Kaiser Permanente Center for Health Research-Kaiser Permanente Medical Center ( Site 1644)
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center ( Site 1647)
    • Tennessee
      • Knoxville, Tennessee, United States, 37916
        • Thompson Cancer Survival Center ( Site 1695)
    • Texas
      • Houston, Texas, United States, 77090
        • Millenium Physicians ( Site 1690)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Biological: Pembrolizumab
IV infusion of pembrolizumab at 200 mg
Other Names:
  • MK-3475
  • KEYTRUDA®
Drug: Lenvatinib
Oral capsules (unit strength: 4 and 10 mg) at 20 mg or 24 mg total daily dose.
Other Names:
  • E7080
  • MK-7902
  • LENVIMA®
Active Comparator: 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.
Drug: Docetaxel
IV infusion of docetaxel at 75 mg/m^2.
Other Names:
  • TAXOTERE®
Experimental: Lenvatinib Monotherapy
Participants receive lenvatinib at 24 mg, QD via oral capsule. Lenvantinib will be administered until progressive disease or unacceptable toxicity.
Drug: Lenvatinib
Oral capsules (unit strength: 4 and 10 mg) at 20 mg or 24 mg total daily dose.
Other Names:
  • E7080
  • MK-7902
  • LENVIMA®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to ~47 months
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)
Time Frame: Up to ~47 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+Lenvatinib vs. Docetaxel
Time Frame: Up to ~47 months
ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions). ORR was assessed by 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
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+Lenvatinib vs. Lenvatinib Monotherapy
Time Frame: Up to ~47 months
ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions). ORR was assessed by 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
Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Time Frame: Up to ~47 months
DOR is defined as the time from first documented evidence of Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) until disease progression or death due to any cause, whichever occurs first. DOR was assessed by 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
Number of Participants Experiencing an Adverse Event (AE)
Time Frame: Up to ~47 months
An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced an AE is presented.
Up to ~47 months
Number of Participants Discontinuing Study Treatment Due to an AE
Time Frame: Up to ~47 months
The number of participants who discontinued study treatment due to an AE is presented.
Up to ~47 months
Change From Baseline in European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Combined Global Health Status / Quality of Life (Items 29 & 30) Scale Combined Score
Time Frame: Baseline and Week 12
The EORTC QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of cancer patients, including a combined global health status (GHS)/QoL (Items 29 and 30) scale. For each item, scores range from 0-100, with higher scores indicating higher GHS/QoL. Per protocol, scores for items 29 and 30 will be averaged to compute a combined GHS/QoL scale score. Change from baseline in the combined GHS/QoL scale scores is presented.
Baseline and Week 12
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 31) Scale Score
Time Frame: Baseline and Week 12
Used in combination with QLQ-C30, the EORTC QLQ-LC13 is a supplemental lung cancer-specific module, including a single-item scale score for cough (Item 31). For this item, individual responses to the question "How much did you cough?" are given on a 4-point scale (1=Not at all; 4=Very much). Scores are transformed to a range from 0-100, with a lower score indicating a better outcome. The change from baseline in the EORTC QLQ-LC13 cough (Item 31) scale score is presented.
Baseline and Week 12
Change From Baseline in EORTC QLQ-LC13 Chest Pain (Item 40) Scale Score
Time Frame: Baseline and Week 12
Used in combination with QLQ-C30, the EORTC QLQ-LC13 is a supplemental lung cancer-specific module, including a single-item scale score for chest pain (Item 40). For this item, individual responses to the question "Have you had pain in your chest?" are given on a 4-point scale (1=Not at all; 4=Very much). Scores are transformed to a range from 0-100, with a lower score indicating a better outcome. The change from baseline in the EORTC QLQ-LC13 chest pain (Item 40) scale score is presented.
Baseline and Week 12
Change From Baseline in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score
Time Frame: Baseline and Week 12
The EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients, including a single-item scale score for dyspnea (Item 8). For this item, individual responses to the question "Were you short of breath?" are given on a 4-point scale (1=Not at all; 4=Very much). Scores are transformed to a range from 0-100, with a lower score indicating a better outcome. The change from baseline in the EORTC QLQ-C30 dyspnea (Item 8) scale score is presented.
Baseline and Week 12
Change From Baseline in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Combined Score
Time Frame: Baseline and Week 12
The EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients, including a physical functioning (PF) scale (Items 1 to 5). The PF scale consists of participant responses to 5 questions regarding performance of daily activities [1) strenuous activities; 2) long walks; 3) short walks; 4) bed/chair rest; and 5) needing help with eating, dressing, washing themselves or using the toilet]. Overall PF scores range from 0 to 100, with a lower score indicating a better outcome. The change from Baseline in the EORTC QLQ-C30 PF (Items 1 to 5) scale combined score is presented.
Baseline and Week 12
Time to True Deterioration (TTD) in EORTC QLQ-C30 Combined Global Health Status / Quality of Life (Items 29 & 30) Scale Combined Score
Time Frame: Up to 24 months
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients, including a combined GHS/QoL (Items 29 and 30) scale. The TTD in the combined GHS/QoL (Items 29 & 30) scale combined score is presented, defined as the time to first onset of a ≥10 point decrease from baseline. A longer TTD indicates a better outcome
Up to 24 months
Time to True Deterioration (TTD) in EORTC QLQ-LC13 Cough (Item 31) Scale Score
Time Frame: Up to ~24 months
Used in combination with QLQ-C30, the EORTC QLQ-LC13 is a supplemental lung cancer-specific module, including a single-item scale score for cough (Item 31). The TTD in EORTC QLQ-LC13 cough (Item 31) scale score is presented, defined as the time to first onset of a ≥10 point decrease from baseline.
Up to ~24 months
Time to True Deterioration (TTD) in EORTC QLQ-LC13 Chest Pain (Item 40) Scale Score
Time Frame: Up to ~24 months
Used in combination with QLQ-C30, the EORTC QLQ-LC13 is a supplemental lung cancer-specific module, including a single-item scale score for chest pain (Item 40). The TTD in EORTC QLQ-LC13 chest pain (Item 40) scale score is presented, defined as the time to first onset of a ≥10 point decrease from baseline.
Up to ~24 months
Time to True Deterioration (TTD) in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score
Time Frame: Up to ~24 months
The EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients, including a single-item scale score for dyspnea (Item 8). The TTD in dyspnea (Item 8) scale score will be presented, defined as the time to first onset of a ≥10 point decrease from baseline.
Up to ~24 months
Time to True Deterioration (TTD) in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Combined Score
Time Frame: Up to ~24 months
The EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients, including a physical functioning (PF) scale (Items 1 to 5). The TTD in PF (Items 1 to 5) scale combined score is presented, defined as the time to first onset of a ≥10 point decrease from baseline.
Up to ~24 months
Time to True Deterioration (TTD) in EORTC Composite Symptom Score for Cough (QLQ-LC13 Item 31), Chest Pain (QLQ-LC13 Item 40), or Dyspnea (QLQ-C30 Item 8)
Time Frame: Up to ~ 24 months
EORTC QLQ-C30 includes a single-item scale score for dyspnea (Item 8), the EORTC QLQ-LC13 is a supplemental lung cancer-specific module, which includes a single-item scale score for cough (Item 31) and chest pain (Item 40). Time to True Deterioration for the Composite Endpoint of EORTC QLQ- LC13 Cough, EORTC QLQ- LC13 Chest Pain, or EORTC QLQ-C30 Dyspnea is presented, defined as the time to first onset of a ≥10-point decrease from baseline in any one of 3 scale items with confirmation by the subsequent visit of a 10 or more-point deterioration from baseline in the same scale as the first onset under right-censoring rule.
Up to ~ 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Collaborators

Eisai Inc.

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2019

Primary Completion (Actual)

August 11, 2023

Study Completion (Actual)

August 22, 2024

Study Registration Dates

First Submitted

June 3, 2019

First Submitted That Met QC Criteria

June 3, 2019

First Posted (Actual)

June 6, 2019

Study Record Updates

Last Update Posted (Estimated)

August 15, 2025

Last Update Submitted That Met QC Criteria

July 30, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7902-008
  • MK-7902-008 (Other Identifier: MSD)
  • LEAP-008 (Other Identifier: MSD)
  • E7080-G000-316 (Other Identifier: Eisai Inc.)
  • 195003 (Registry Identifier: JAPIC-CTI)
  • 2018-003791-12 (EudraCT Number)
  • 2022-501439-18-00 (Registry Identifier: EU CT)
  • U1111-1280-4337 (Registry Identifier: UTN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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