AzTrials
AzTrials

Metastatic Non-Small Cell Lung CancerPhase 3NCT03976375

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)

A Phase 3 study testing Pembrolizumab, Lenvatinib and Docetaxel in people with Metastatic Non-Small Cell Lung Cancer, run by Merck Sharp & Dohme LLC at 143 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Non-Small Cell Lung Cancer
What is being tested?
Pembrolizumab, Lenvatinib and Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
422 participants
Where
143 sitesin 18 countries
Study dates
26 Jun 2019to 22 Aug 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

143 sites in 18 countries.

143 sites in 18 countries

United States28 sites

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

    Bakersfield, California, 93309

  • Harry & Jeanette Weinberg Cancer Institute ( Site 1626)

    Baltimore, Maryland, 21237

  • Medstar Good Samaritan Hospital ( Site 1625)

    Baltimore, Maryland, 21239

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

    Basking Ridge, New Jersey, 07920

  • Hematology Oncology Clinic ( Site 1680)

    Baton Rouge, Louisiana, 70809

  • Billings Clinic ( Site 1631)

    Billings, Montana, 59101

  • Massachusetts General Hospital ( Site 1622)

    Boston, Massachusetts, 02114

  • Bozeman Health Deaconness Cancer Center ( Site 1632)

    Bozeman, Montana, 59715

  • TriHealth Cancer Institute ( Site 1672)

    Cincinnati, Ohio, 45220

  • MetroHealth Medical Center ( Site 1694)

    Cleveland, Ohio, 44109

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

    Commack, New York, 11725

  • MGH - North Shore Cancer Center ( Site 1668)

    Danvers, Massachusetts, 01923

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

    Fleming Island, Florida, 32003

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

    Harrison, New York, 10604

  • Millenium Physicians ( Site 1690)

    Houston, Texas, 77090

  • Thompson Cancer Survival Center ( Site 1695)

    Knoxville, Tennessee, 37916

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

    Lexington, Kentucky, 40536

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

    Middletown, New Jersey, 07748

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

    Montvale, New Jersey, 07645

  • Memorial Sloan-Kettering Cancer Center ( Site 1661)

    New York, New York, 10065

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

    Newton, Massachusetts, 02462

  • Mid-Florida Cancer Centers ( Site 1611)

    Orange City, Florida, 32763

  • Fox Chase Cancer Center ( Site 1647)

    Philadelphia, Pennsylvania, 19111

  • New York Cancer and Blood Specialists ( Site 1696)

    Port Jefferson Station, New York, 11776

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

    Portland, Oregon, 97227

  • University of Rochester ( Site 1638)

    Rochester, New York, 14642

  • Memorial Sloan Kettering Cancer Center - Nassau ( Site 1670)

    Uniondale, New York, 11553

  • University of Massachusetts Medical School ( Site 1693)

    Worcester, Massachusetts, 01655

Other trials in United States

Spain11 sites

  • Hospital Universitari Vall d Hebron ( Site 1004)

    Barcelona, 08035

  • Hospital Ciudad de Jaen ( Site 1000)

    Jaén, 23007

  • Hospital Universitario Insular de Gran Canaria ( Site 1011)

    Las Palmas de Gran Canaria, Las Palmas, 35001

  • Hospital Universitario Fundacion Jimenez Diaz ( Site 1005)

    Madrid, 28040

  • Hospital Universitario 12 de Octubre ( Site 1006)

    Madrid, 28041

  • Hospital Universitario Puerta de Hierro ( Site 1007)

    Majadahonda, Madrid, 28222

  • Consorci Hospitalari Mataro ( Site 1008)

    Mataró, Barcelona, 08304

  • Hospital Central de Asturias ( Site 1002)

    Oviedo, Principality of Asturias, 33011

  • Hospital Universitario Quiron Madrid ( Site 1012)

    Pozuelo de Alarcón, Madrid, 28223

  • Hospital Universitario Marques de Valdecilla ( Site 1003)

    Santander, Cantabria, 39008

  • Hospital Clinico de Valencia ( Site 1010)

    Valencia, Valenciana, Comunitat, 46010

Other trials in Spain

Italy10 sites

  • Azienda Ospedaliera San Giuseppe Moscati ( Site 0809)

    Avellino, 83100

  • IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 0808)

    Bari, 70124

  • AOU Policlinico Vittorio Emanuele ( Site 0811)

    Catania, 95123

  • Istituto Nazionale dei Tumori ( Site 0806)

    Milan, 20133

  • Ospedale San Gerardo - ASST Monza ( Site 0804)

    Monza, Monza E Brianza, 20900

  • Ospedale San Luigi Gonzaga ( Site 0802)

    Orbassano, Torino, 10043

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

    Palermo, Sicily, 90146

  • Policlinico San Matteo - Fondazione IRCCS ( Site 0812)

    Pavia, 27100

  • Azienda Ospedaliera di Perugia ( Site 0805)

    Perugia, 06132

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

    Rome, Roma, 00144

Other trials in Italy

Russia10 sites

  • Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0918)

    Krasnoyarsk, Krasnoyarsk Krai, 660133

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

    Moscow, Moscow, 105094

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

    Moscow, Moscow, 121359

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

    Omsk, Omsk Oblast, 644013

  • Railway Hospital of OJSC ( Site 0907)

    Saint Petersburg, Sankt-Peterburg, 195271

  • Pavlov First Saint Petersburg State Medical University ( Site 0917)

    Saint Petersburg, Sankt-Peterburg, 197022

  • GBUZ SPb CRPCstmc(o) ( Site 0921)

    Saint Petersburg, Sankt-Peterburg, 197758

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

    Saint Petersburg, Sankt-Peterburg, 197758

  • SPb SBHI City Clinical Oncological Dispensary ( Site 0901)

    Saint Petersburg, Sankt-Peterburg, 198255

  • GBUZ Republican Clinical Oncological Dispensary ( Site 0922)

    Ufa, Baskortostan, Respublika, 450054

Other trials in Russia

United Kingdom10 sites

  • Aberdeen Royal Infirmary ( Site 1114)

    Aberdeen, Scotland, AB25 2ZN

  • Birmingham Heartlands Hospital ( Site 1103)

    Birmingham, B9 5SS

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

    Cottingham, East Riding Of Yorkshire, HU16 5JQ

  • University Hospital Coventry and Warwickshire NHS Trust ( Site 1112)

    Coventry, Warwickshire, CV2 2DX

  • St James s University Hospital ( Site 1106)

    Leeds, LS9 7TF

  • Leicester Royal Infirmary ( Site 1110)

    Leicester, Leicestershire, LE1 5WW

  • North Middlesex University Hospital NHS Trust ( Site 1109)

    London, London, City of, N18 1QX

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

    London, London, City of, SE1 9RT

  • Mount Vernon Cancer Centre ( Site 1107)

    Northwood, London, City of, HA6 2RN

  • Nottingham City Hospital Campus ( Site 1105)

    Nottingham, England, NG5 1PB

Other trials in United Kingdom

Hungary9 sites

  • Semmelweis Egyetem.. ( Site 0604)

    Budapest, 1083

  • Orszagos Koranyi Pulmonologiai Intezet ( Site 0603)

    Budapest, 1121

  • Orszagos Koranyi Pulmonologiai Intezet ( Site 0608)

    Budapest, 1121

  • Veszprem Megyei Tudogyogyintezet ( Site 0607)

    Farkasgyepű, Veszprém megye, 8582

  • Petz Aladar Megyei Oktato Korhaz ( Site 0609)

    Győr, Győr-Moson-Sopron, 9024

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

    Miskolc, Borsod-Abauj Zemplen county, 3526

  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 0606)

    Székesfehérvár, Fejér, 8000

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

    Szolnok, Jász-Nagykun-Szolnok, 5004

  • Tudogyogyintezet Torokbalint ( Site 0602)

    Törökbálint, Pest County, 2045

Other trials in Hungary

France8 sites

  • ICO Centre Paul Papin ( Site 0412)

    Angers, Maine-et-Loire, 49100

  • Centre Hospitalier General - Avignon ( Site 0407)

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

  • Clinique Ambroise Pare ( Site 0402)

    Beuvry, Pas-de-Calais, 62660

  • CHU Caen Service de Pneumologie ( Site 0401)

    Caen, Calvados, 14033

  • HIA Percy-Clamart ( Site 0411)

    Clamart, Hauts-de-Seine, 92140

  • Centre Hospitalier Le Mans ( Site 0406)

    Le Mans, Sarthe, 72037

  • Institut Curie ( Site 0400)

    Paris, 75005

  • Hopital Europeen Georges Pompidou ( Site 0408)

    Paris, 75015

Other trials in France

Australia7 sites

  • Bendigo Cancer Centre ( Site 0008)

    Bendigo, Victoria, 3552

  • Blacktown Hospital ( Site 0004)

    Blacktown, New South Wales, 2148

  • Calvary Central Districts Hospital ( Site 0007)

    Elizabeth Vale, South Australia, 5112

  • Port Macquarie Base Hospital ( Site 0003)

    Port Macquarie, New South Wales, 2444

  • Westmead Hospital ( Site 0005)

    Westmead, New South Wales, 2145

  • Southern Medical Day Care Centre ( Site 0001)

    Wollongong, New South Wales, 2500

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

    Woolloongabba, Queensland, 4102

Other trials in Australia

Colombia7 sites

  • Clinica de la Costa Ltda. ( Site 1309)

    Barranquilla, Atlántico, 080020

  • Administradora Country SA - Clinica del Country ( Site 1307)

    Bogotá, Bogota D.C., 110221

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

    Bogotá, Bogota D.C., 110311

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

    Cali, Valle del Cauca Department, 760042

  • Rodrigo Botero SAS ( Site 1300)

    Medellín, Antioquia, 050030

  • Oncomedica S.A. ( Site 1302)

    Montería, Departamento de Córdoba, 230001

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

    Valledupar, Cesar Department, 200001

Other trials in Colombia

Israel7 sites

  • Soroka Medical Center ( Site 0701)

    Beersheba, 8410101

  • Rambam Medical Center ( Site 0703)

    Haifa, 3525408

  • Shaare Zedek Medical Center-Oncology ( Site 0706)

    Jerusalem, 9013102

  • Meir Medical Center ( Site 0702)

    Kfar Saba, 4428132

  • Rabin Medical Center ( Site 0700)

    Petah Tikva, 4941492

  • Chaim Sheba Medical Center ( Site 0704)

    Ramat Gan, 5262000

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

    Tel Aviv, 6423906

Other trials in Israel

Japan7 sites

  • Chiba University Hospital ( Site 0106)

    Chiba, 260-8677

  • Kansai Medical University Hospital ( Site 0104)

    Hirakata, Osaka, 573-1191

  • Niigata Cancer Center Hospital ( Site 0101)

    Niigata, 951-8566

  • Sendai Kousei Hospital ( Site 0107)

    Sendai, Miyagi, 980-0873

  • National Cancer Center Hospital ( Site 0103)

    Tokyo, 104-0045

  • The Cancer Institute Hospital of JFCR ( Site 0100)

    Tokyo, 135-8550

  • Kanagawa Cardiovascular and Respiratory Center ( Site 0105)

    Yokohama, Kanagawa, 236-0051

Other trials in Japan

Canada6 sites

  • Kingston Health Sciences Centre ( Site 1503)

    Kingston, Ontario, K7L 2V7

  • London Regional Cancer Program - London HSC ( Site 1505)

    London, Ontario, N6A 5W9

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

    Montreal, Quebec, H3T 1M5

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

    Québec, Quebec, G1R 2J6

  • Princess Margaret Cancer Centre ( Site 1502)

    Toronto, Ontario, M5G 2M9

  • CancerCare Manitoba ( Site 1504)

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Argentina5 sites

  • Hospital Britanico de Buenos Aires ( Site 2002)

    Buenos Aires, Buenos Aires F.D., C1280AEB

  • Hospital Aleman ( Site 2000)

    Buenos Aires, C1118AAT

  • CEMIC ( Site 2003)

    Buenos Aires, C1431FWO

  • Instituto de Investigaciones Metabolicas ( Site 2004)

    Caba, Buenos Aires, C1012AAR

  • Sanatorio Parque ( Site 2005)

    Rosario, Santa Fe Province, S2000DSV

Other trials in Argentina

Germany4 sites

  • Vivantes Klinikum Spandau ( Site 0505)

    Berlin, 13585

  • SRH Wald-Klinikum Gera GmbH ( Site 0503)

    Gera, Thuringia, 07548

  • Evangelisches Krankenhaus Hamm gGmbH ( Site 0504)

    Hamm, North Rhine-Westphalia, 59063

  • Thoraxklinik Heidelberg gGmbH am Universitaetsklinikum Heidelberg ( Site 0501)

    Heidelberg, Baden-Wurttemberg, 69126

Other trials in Germany

Greece4 sites

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

    Athens, Attica, 115 27

  • Metropolitan Hospital-4th Oncology Dept ( Site 1700)

    Athens, Attica, 185 47

  • University Hospital of Ioannina ( Site 1701)

    Ioannina, 455 00

  • European Interbalkan Medical Center ( Site 1704)

    Thessaloniki, 570 01

Other trials in Greece

South Korea4 sites

  • Chungbuk National University Hospital ( Site 0201)

    Cheongju-si, North Chungcheong, 28644

  • Seoul National University Bundang Hospital ( Site 0204)

    Seongnam-si, Kyonggi-do, 13620

  • Severance Hospital Yonsei University Health System ( Site 0202)

    Seoul, 03722

  • Asan Medical Center ( Site 0203)

    Songpagu, Seoul, 05505

Other trials in South Korea

Portugal3 sites

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

    Lisbon, 1769-001

  • Hospital CUF Porto ( Site 1802)

    Porto, 4100-180

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

    Porto, 4200-072

Other trials in Portugal

Puerto Rico3 sites

  • Hematology and Oncology Institute ( Site 2105)

    Manati, 00674

  • Ad-Vance Medical Research LLC ( Site 2103)

    Ponce, 00717

  • Puerto Rico Medical Research Center LLC ( Site 2101)

    San Juan, 00918

Other trials in Puerto Rico

About this study

Official title: 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).

Keywords
programmed cell death 1 (PD-1, PD1), programmed cell death-ligand 1 (PD-L1, PDL1), programmed cell death-ligand 2 (PD-L2, PDL2)
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabBiological

    Also called MK-3475, KEYTRUDA®

    IV infusion of pembrolizumab at 200 mg

  • LenvatinibDrug

    Also called MK-7902, E7080, LENVIMA®

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

  • DocetaxelDrug

    Also called TAXOTERE®

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

Study groups in NCT03976375
Study groupRoleWhat they receive
Pembrolizumab+LenvatinibExperimentalParticipants 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.
Receives: Biological: Pembrolizumab; Drug: Lenvatinib
DocetaxelActive comparatorParticipants 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.
Receives: Drug: Docetaxel
Lenvatinib MonotherapyExperimentalParticipants receive lenvatinib at 24 mg, QD via oral capsule. Lenvantinib will be administered until progressive disease or unacceptable toxicity.
Receives: Drug: Lenvatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

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

    Measured: Up to ~47 months

  2. 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.

    Measured: Up to ~47 months

Secondary outcomes (16)

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

    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.

    Measured: Up to ~47 months

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

    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.

    Measured: Up to ~47 months

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

    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.

    Measured: Up to ~47 months

  4. Number of Participants Experiencing an Adverse Event (AE)

    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.

    Measured: Up to ~47 months

  5. Number of Participants Discontinuing Study Treatment Due to an AE

    The number of participants who discontinued study treatment due to an AE is presented.

    Measured: Up to ~47 months

  6. 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

    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.

    Measured: Baseline and Week 12

  7. Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 31) Scale Score

    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.

    Measured: Baseline and Week 12

  8. Change From Baseline in EORTC QLQ-LC13 Chest Pain (Item 40) Scale Score

    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.

    Measured: Baseline and Week 12

  9. Change From Baseline in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score

    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.

    Measured: Baseline and Week 12

  10. Change From Baseline in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Combined Score

    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.

    Measured: Baseline and Week 12

  11. Time to True Deterioration (TTD) in EORTC QLQ-C30 Combined Global Health Status / Quality of Life (Items 29 & 30) Scale Combined Score

    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

    Measured: Up to 24 months

  12. Time to True Deterioration (TTD) in EORTC QLQ-LC13 Cough (Item 31) Scale Score

    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.

    Measured: Up to ~24 months

  13. Time to True Deterioration (TTD) in EORTC QLQ-LC13 Chest Pain (Item 40) Scale Score

    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.

    Measured: Up to ~24 months

  14. Time to True Deterioration (TTD) in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score

    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.

    Measured: Up to ~24 months

  15. Time to True Deterioration (TTD) in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Combined Score

    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.

    Measured: Up to ~24 months

  16. 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)

    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.

    Measured: Up to ~ 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2019
  2. Study start26 Jun 2019
  3. Primary completion11 Aug 2023
  4. Study completion22 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
422 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03976375
Sponsor's protocol ID
7902-008
Other IDs
MK-7902-008, LEAP-008, E7080-G000-316, 195003, 2022-501439-18-00, U1111-1280-4337, 2018-003791-12, 2018
Status last verified
Jul 2025
First submitted
3 Jun 2019
Last updated
15 Aug 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

  • 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.

    PubMed 40473109

  • 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.

    PubMed 34409776

  • 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.

    PubMed 33300372

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pembrolizumab, Lenvatinib and Docetaxel in people with Metastatic Non-Small Cell Lung Cancer, run by Merck Sharp & Dohme LLC at 143 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 143 sites in United States, Spain, Italy, Russia, United Kingdom and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Up to ~47 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03976375, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.

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