Lung Cancer Clinical Trial

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)

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).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Has a histologically or cytologically confirmed diagnosis of metastatic squamous or nonsquamous NSCLC (Stage IV: M1a, M1b, M1c).

Has PD on treatment with one prior anti-PD-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 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 is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

422

Study ID:

NCT03976375

Recruitment Status:

Active, not recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 141 Locations for this study

See Locations Near You

Comprehensive Blood & Cancer Center [Bakersfield, CA] ( Site 1604)
Bakersfield California, 93309, United States
Cancer Specialists of North Florida - Fleming Island ( Site 1675)
Fleming Island Florida, 32003, United States
Mid-Florida Cancer Centers ( Site 1611)
Orange City Florida, 32763, United States
University of Kentucky School of Medicine & Hospitals ( Site 1621)
Lexington Kentucky, 40536, United States
Hematology Oncology Clinic ( Site 1680)
Baton Rouge Louisiana, 70809, United States
Harry & Jeanette Weinberg Cancer Institute ( Site 1626)
Baltimore Maryland, 21237, United States
Medstar Good Samaritan Hospital ( Site 1625)
Baltimore Maryland, 21239, United States
Massachusetts General Hospital ( Site 1622)
Boston Massachusetts, 02114, United States
MGH - North Shore Cancer Center ( Site 1668)
Danvers Massachusetts, 01923, United States
The Mass General Cancer Center at Newton-Wellesley ( Site 1692)
Newton Massachusetts, 02462, United States
University of Massachusetts Medical School ( Site 1693)
Worcester Massachusetts, 01655, United States
Billings Clinic ( Site 1631)
Billings Montana, 59101, United States
Bozeman Health Deaconness Cancer Center ( Site 1632)
Bozeman Montana, 59715, United States
Memorial Sloan-Kettering Cancer Center At Basking Ridge ( Site 1664)
Basking Ridge New Jersey, 07920, United States
Memorial Sloan-Kettering Cancer Center at Middletown ( Site 1665)
Middletown New Jersey, 07748, United States
Memorial Sloan-Kettering Cancer Center at Montvale ( Site 1667)
Montvale New Jersey, 07645, United States
Memorial Sloan-Kettering Cancer Center at Commack ( Site 1662)
Commack New York, 11725, United States
Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 1666)
Harrison New York, 10604, United States
Memorial Sloan-Kettering Cancer Center ( Site 1661)
New York New York, 10065, United States
New York Cancer and Blood Specialists ( Site 1696)
Port Jefferson Station New York, 11776, United States
University of Rochester ( Site 1638)
Rochester New York, 14642, United States
Memorial Sloan Kettering Cancer Center - Nassau ( Site 1670)
Uniondale New York, 11553, United States
TriHealth Cancer Institute ( Site 1672)
Cincinnati Ohio, 45220, United States
MetroHealth Medical Center ( Site 1694)
Cleveland Ohio, 44109, United States
Kaiser Permanente Center for Health Research-Kaiser Permanente Medical Center ( Site 1644)
Portland Oregon, 97227, United States
Fox Chase Cancer Center ( Site 1647)
Philadelphia Pennsylvania, 19111, United States
Thompson Cancer Survival Center ( Site 1695)
Knoxville Tennessee, 37916, United States
Millenium Physicians ( Site 1690)
Houston Texas, 77090, United States
Instituto de Investigaciones Metabolicas ( Site 2004)
Caba Buenos Aires, C1012, Argentina
Hospital Britanico de Buenos Aires ( Site 2002)
Buenos Aires Caba, C1280, Argentina
Sanatorio Parque ( Site 2005)
Rosario Santa Fe, S2000, Argentina
Hospital Aleman ( Site 2000)
Buenos Aires , C1118, Argentina
CEMIC ( Site 2003)
Buenos Aires , C1431, Argentina
Blacktown Hospital ( Site 0004)
Blacktown New South Wales, 2148, Australia
Port Macquarie Base Hospital ( Site 0003)
Port Macquarie New South Wales, 2444, Australia
Westmead Hospital ( Site 0005)
Westmead New South Wales, 2145, Australia
Southern Medical Day Care Centre ( Site 0001)
Wollongong New South Wales, 2500, Australia
Princess Alexandra Hospital - Division of Cancer Services ( Site 0002)
Woolloongabba Queensland, 4102, Australia
Calvary Central Districts Hospital ( Site 0007)
Elizabeth Vale South Australia, 5112, Australia
Bendigo Cancer Centre ( Site 0008)
Bendigo Victoria, 3552, Australia
CancerCare Manitoba ( Site 1504)
Winnipeg Manitoba, R3E 0, Canada
Kingston Health Sciences Centre ( Site 1503)
Kingston Ontario, K7L 2, Canada
London Regional Cancer Program - London HSC ( Site 1505)
London Ontario, N6A 5, Canada
Princess Margaret Cancer Centre ( Site 1502)
Toronto Ontario, M5G 2, Canada
CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 1501)
Montreal Quebec, H3T 1, Canada
CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 1514)
Quebec , G1R 2, Canada
Rodrigo Botero SAS ( Site 1300)
Medellin Antioquia, 05003, Colombia
Clinica de la Costa Ltda. ( Site 1309)
Barranquilla Atlantico, 08002, Colombia
Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 1305)
Valledupar Cesar, 20000, Colombia
Oncomedica S.A. ( Site 1302)
Monteria Cordoba, 23000, Colombia
Administradora Country SA - Clinica del Country ( Site 1307)
Bogota Distrito Capital De Bogota, 11022, Colombia
Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 1304)
Bogota Distrito Capital De Bogota, 11031, Colombia
Centro Medico Imbanaco de Cali S.A ( Site 1301)
Cali Valle Del Cauca, 76004, Colombia
CHU Caen Service de Pneumologie ( Site 0401)
Caen Calvados, 14033, France
HIA Percy-Clamart ( Site 0411)
Clamart Hauts-de-Seine, 92140, France
ICO Centre Paul Papin ( Site 0412)
Angers Maine-et-Loire, 49100, France
Clinique Ambroise Pare ( Site 0402)
Beuvry Pas-de-Calais, 62660, France
Centre Hospitalier General - Avignon ( Site 0407)
Avignon Provence-Alpes-Cote-d Azur, 84000, France
Centre Hospitalier Le Mans ( Site 0406)
Le Mans Sarthe, 72037, France
Institut Curie ( Site 0400)
Paris , 75005, France
Hopital Europeen Georges Pompidou ( Site 0408)
Paris , 75015, France
Thoraxklinik Heidelberg gGmbH am Universitaetsklinikum Heidelberg ( Site 0501)
Heidelberg Baden-Wurttemberg, 69126, Germany
Evangelisches Krankenhaus Hamm gGmbH ( Site 0504)
Hamm Nordrhein-Westfalen, 59063, Germany
SRH Wald-Klinikum Gera GmbH ( Site 0503)
Gera Thuringen, 07548, Germany
Vivantes Klinikum Spandau ( Site 0505)
Berlin , 13585, Germany
General Hospital of Chest Diseases "Sotiria" ( Site 1703)
Athens Attiki, 115 2, Greece
Metropolitan Hospital-4th Oncology Dept ( Site 1700)
Athens Attiki, 185 4, Greece
University Hospital of Ioannina ( Site 1701)
Ioannina , 455 0, Greece
European Interbalkan Medical Center ( Site 1704)
Thessaloniki , 570 0, Greece
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház ( Site 0601)
Miskolc Borsod-Abauj-Zemplen, 3526, Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 0606)
Szekesfehervar Fejer, 8000, Hungary
Petz Aladar Megyei Oktato Korhaz ( Site 0609)
Gyor Gyor-Moson-Sopron, 9024, Hungary
Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0610)
Szolnok Jasz-Nagykun-Szolnok, 5004, Hungary
Tudogyogyintezet Torokbalint ( Site 0602)
Torokbalint Pest, 2045, Hungary
Veszprem Megyei Tudogyogyintezet ( Site 0607)
Farkasgyepu Veszprem, 8582, Hungary
Semmelweis Egyetem.. ( Site 0604)
Budapest , 1083, Hungary
Orszagos Koranyi Pulmonologiai Intezet ( Site 0603)
Budapest , 1121, Hungary
Orszagos Koranyi Pulmonologiai Intezet ( Site 0608)
Budapest , 1121, Hungary
Soroka Medical Center ( Site 0701)
Beer Sheva , 84101, Israel
Rambam Medical Center ( Site 0703)
Haifa , 35254, Israel
Shaare Zedek Medical Center-Oncology ( Site 0706)
Jerusalem , 90131, Israel
Meir Medical Center ( Site 0702)
Kfar-Saba , 44281, Israel
Rabin Medical Center ( Site 0700)
Petah Tikva , 49414, Israel
Chaim Sheba Medical Center ( Site 0704)
Ramat Gan , 52620, Israel
Sourasky Medical Center (Ichilov) - Oncology Clinic ( Site 0705)
Tel Aviv , 64239, Israel
Ospedale San Gerardo - ASST Monza ( Site 0804)
Monza Monza E Brianza, 20900, Italy
Istittuto Nazionale dei Tumori Regina Elena IRCCS - IFO ( Site 0807)
Rome Roma, 00144, Italy
A.O. Ospedali Riuniti Villa Sofia - Cervello P.O. Villa Sofia ( Site 0810)
Palermo Sicilia, 90146, Italy
Ospedale San Luigi Gonzaga ( Site 0802)
Orbassano Torino, 10043, Italy
Azienda Ospedaliera San Giuseppe Moscati ( Site 0809)
Avellino , 83100, Italy
IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 0808)
Bari , 70124, Italy
AOU Policlinico Vittorio Emanuele ( Site 0811)
Catania , 95123, Italy
Istituto Nazionale dei Tumori ( Site 0806)
Milano , 20133, Italy
Policlinico San Matteo - Fondazione IRCCS ( Site 0812)
Pavia , 27100, Italy
Azienda Ospedaliera di Perugia ( Site 0805)
Perugia , 06132, Italy
Kanagawa Cardiovascular and Respiratory Center ( Site 0105)
Yokohama Kanagawa, 236-0, Japan
Sendai Kousei Hospital ( Site 0107)
Sendai Miyagi, 980-0, Japan
Kansai Medical University Hospital ( Site 0104)
Hirakata Osaka, 573-1, Japan
Chiba University Hospital ( Site 0106)
Chiba , 260-8, Japan
Niigata Cancer Center Hospital ( Site 0101)
Niigata , 951-8, Japan
National Cancer Center Hospital ( Site 0103)
Tokyo , 104-0, Japan
The Cancer Institute Hospital of JFCR ( Site 0100)
Tokyo , 135-8, Japan
Chungbuk National University Hospital ( Site 0201)
Cheongju si Chungbuk, 28644, Korea, Republic of
Seoul National University Bundang Hospital ( Site 0204)
Seongnam-si Kyonggi-do, 13620, Korea, Republic of
Asan Medical Center ( Site 0203)
Songpagu Seoul, 05505, Korea, Republic of
Severance Hospital Yonsei University Health System ( Site 0202)
Seoul , 03722, Korea, Republic of
Centro Hospitalar Lisboa Norte E.P.E. - Hospital Pulido Valente ( Site 1801)
Lisboa , 1769-, Portugal
Hospital CUF Porto ( Site 1802)
Porto , 4100-, Portugal
Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 1800)
Porto , 4200-, Portugal
Hematology and Oncology Institute ( Site 2105)
Manati , 00674, Puerto Rico
Ad-Vance Medical Research LLC ( Site 2103)
Ponce , 00717, Puerto Rico
Puerto Rico Medical Research Center LLC ( Site 2101)
San Juan , 00918, Puerto Rico
GBUZ Republican Clinical Oncological Dispensary ( Site 0922)
Ufa Baskortostan, Respublika, 45005, Russian Federation
Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0918)
Krasnoyarsk Krasnoyarskiy Kray, 66013, Russian Federation
Main Military Clinical Hospital n.a. N.N.Burdenko ( Site 0905)
Moscow Moskva, 10509, Russian Federation
Central Clinical Hospital of the Administration of the President ( Site 0910)
Moscow Moskva, 12135, Russian Federation
Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary-Chemotherapy #1 ( Site
Omsk Omskaya Oblast, 64401, Russian Federation
SPb SBHI City Clinical Oncological Dispensary ( Site 0901)
Saint Petersburg Sankt-Peterburg, 19825, Russian Federation
Railway Hospital of OJSC ( Site 0907)
Saint-Petersburg Sankt-Peterburg, 19527, Russian Federation
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0903)
Saint-Petersburg Sankt-Peterburg, 19775, Russian Federation
GBUZ SPb CRPCstmc(o) ( Site 0921)
Sankt- Peterburg Sankt-Peterburg, 19775, Russian Federation
Pavlov First Saint Petersburg State Medical University ( Site 0917)
St. Petersburg Sankt-Peterburg, 19702, Russian Federation
Hospital Central de Asturias ( Site 1002)
Oviedo Asturias, 33011, Spain
Consorci Hospitalari Mataro ( Site 1008)
Mataro Barcelona, 08304, Spain
Hospital Universitario Marques de Valdecilla ( Site 1003)
Santander Cantabria, 39008, Spain
Hospital Universitario Insular de Gran Canaria ( Site 1011)
Las Palmas de Gran Canaria Las Palmas, 35001, Spain
Hospital Universitario Puerta de Hierro ( Site 1007)
Majadahonda Madrid, 28222, Spain
Hospital Universitario Quiron Madrid ( Site 1012)
Pozuelo de Alarcon Madrid, 28223, Spain
Hospital Clinico de Valencia ( Site 1010)
Valencia Valenciana, Comunitat, 46010, Spain
Hospital Universitari Vall d Hebron ( Site 1004)
Barcelona , 08035, Spain
Hospital Ciudad de Jaen ( Site 1000)
Jaen , 23007, Spain
Hospital Universitario Fundacion Jimenez Diaz ( Site 1005)
Madrid , 28040, Spain
Hospital Universitario 12 de Octubre ( Site 1006)
Madrid , 28041, Spain
Hull & East Yorkshire NHS Trust. Castle Hill Hospital ( Site 1108)
Cottingham East Riding Of Yorkshire, HU16 , United Kingdom
Nottingham City Hospital Campus ( Site 1105)
Nottingham England, NG5 1, United Kingdom
Leicester Royal Infirmary ( Site 1110)
Leicester Leicestershire, LE1 5, United Kingdom
North Middlesex University Hospital NHS Trust ( Site 1109)
London London, City Of, N18 1, United Kingdom
Guy s and St Thomas Hospital NHS Foundation Trust ( Site 1102)
London London, City Of, SE1 9, United Kingdom
Mount Vernon Cancer Centre ( Site 1107)
Northwood London, City Of, HA6 2, United Kingdom
Aberdeen Royal Infirmary ( Site 1114)
Aberdeen Scotland, AB25 , United Kingdom
University Hospital Coventry and Warwickshire NHS Trust ( Site 1112)
Coventry Warwickshire, CV2 2, United Kingdom
Birmingham Heartlands Hospital ( Site 1103)
Birmingham , B9 5S, United Kingdom
St James s University Hospital ( Site 1106)
Leeds , LS9 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

422

Study ID:

NCT03976375

Recruitment Status:

Active, not recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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