Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) in Adults With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Treatment-naïve Nonsmall Cell Lung Cancer (NSCLC) (MK-7902-007/E7080-G000-314/LEAP-007)

NCT03829332 | Completed Phase 3 Results DMC FDA Drug

• 6 other identifiers: 7902-007MK-7902-007E7080-G000-314LEAP-0071946702018-003794-98
• Study Type: interventional
• Target: 623
• Locations: 19 countries
• Sites: 162

Brief Summary

The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combined with lenvatinib (MK-7902/E7080) compared to pembrolizumab alone (with placebo for lenvatinib) in treatment-naïve adults with no prior systemic therapy for their metastatic non-small cell lung cancer (NSCLC) whose tumors have a programmed cell death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) greater than or equal to 1%. The primary study hypotheses are that: 1) the combination of pembrolizumab and lenvatinib is superior to pembrolizumab alone as assessed by Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1); and 2) the combination of pembrolizumab and lenvatinib is superior to pembrolizumab alone as assessed by Overall Survival (OS).

Conditions

Non-small Cell Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

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

  PFS was defined as the time from date of randomization to the date of the first documentation of progressive disease (PD) or death from any cause, whichever occurred first. Per RECIST 1.1, PD was 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. The appearance of one or more new lesions was also considered PD. Data are from the product-limit (Kaplan-Meier) method for censored data. PFS as assessed by blinded independent central review (BICR) per RECIST 1.1 was presented.

  Up to approximately 25 months

• Overall Survival (OS)

  OS was defined as the time from date of randomization to date of death from any cause. OS was presented.

  Up to approximately 25 months

Secondary Outcomes (14)

• Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

  Up to approximately 25 months

• Number of Participants Who Experienced an Adverse Event (AE)

  Through 90 days post last dose of study treatment (Up to approximately 27 months)

• Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)

  Through last dose of study treatment (Up to approximately 24 months)

• Change From Baseline in European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire-Core30 (QLQ-C30) Combined Global Health Status/Quality of Life (Items 29 & 30) Scale Combined Score

  Baseline and Week 21

• Change From Baseline in Cough (EORTC Quality of Life Questionnaire-Lung Cancer Module 13 [QLQ-LC13] Item 31) Score

  Baseline and Week 21

Study Arms (2)

Pembrolizumab + Lenvatinib

EXPERIMENTAL

Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity.

Biological: Pembrolizumab; Drug: Lenvatinib

Pembrolizumab + Placebo

ACTIVE COMPARATOR

Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule QD on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity.

Biological: Pembrolizumab; Drug: Placebo for lenvatinib

Interventions

Pembrolizumab BIOLOGICAL

IV infusion

Also known as: MK-3475, KEYTRUDA®

Pembrolizumab + Lenvatinib; Pembrolizumab + Placebo

Lenvatinib DRUG

oral capsule

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

Pembrolizumab + Lenvatinib

Placebo for lenvatinib DRUG

oral capsule

Pembrolizumab + Placebo

Eligibility Criteria

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

You may qualify if:

• Has a histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC)
• Has Stage IV NSCLC (American Joint Committee on Cancer \[AJCC 8th edition\])
• Has measurable disease based on RECIST 1.1
• Has tumor tissue that demonstrates programmed cell death-ligand 1 (PD-L1) expression in ≥1% of tumor cells (Tumor Proportion Score \[TPS\] ≥1%) as assessed by immunohistochemistry (IHC) 22C3 pharmDx assay (Dako North America, Inc.) at a central laboratory
• Has a life expectancy of ≥3 months
• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose of study treatment but before randomization
• Male participants must agree to the following during the treatment period and for ≥7 days after the last dose of lenvatinib/matching placebo: 1) Be abstinent from heterosexual intercourse as their preferred and usual lifestyle and agree to remain abstinent, OR 2) Must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause)
• Female participants are eligible to participate if not pregnant or breastfeeding, and ≥1 of the following applies: 1) Is not a woman of child-bearing potential (WOCBP), OR 2) Is a WOCBP and is using a highly effective contraceptive method that has a low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle during the treatment period and for ≥120 days post pembrolizumab or ≥30 days post lenvatinib/matching placebo, whichever occurs last
• 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
• Has adequate organ function

You may not qualify if:

• Has known untreated central nervous system metastases and/or carcinomatous meningitis
• Has active hemoptysis (at least 0.5 teaspoon of bright red blood) within 2 weeks prior to the first dose of study intervention
• Has radiographic evidence of intratumoral cavitations, encasement, or invasion of a major blood vessel
• Has a known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for ≥3 years since initiation of that therapy. (Note: The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers.)
• Has an active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed
• Has had an allogeneic tissue/solid organ transplant
• Has a known history of human immunodeficiency virus (HIV) infection
• Has a history of (noninfectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease
• Has a known history of hepatitis B or known active hepatitis C virus infection
• Has a history of a gastrointestinal condition or procedure that in the opinion of the investigator may affect oral study drug absorption.
• Has significant cardiovascular impairment within 12 months of the first dose of study treatment, such as a history of congestive heart failure greater than New York Heart Association Class II, unstable angina, myocardial infarction, cerebrovascular accident/stroke, or cardiac arrhythmia associated with hemodynamic instability
• Has not recovered adequately from any toxicity and/or complications from major surgery before starting study treatment
• Has a known history of active tuberculosis (TB)
• Has an active infection requiring systemic therapy
• Has previously had a severe hypersensitivity reaction to treatment with a monoclonal antibody or has a known sensitivity or intolerance to any component of lenvatinib or pembrolizumab

Sponsors & Collaborators

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

Study Sites (162)

Alaska Clinical Research Center ( Site 0511)

Anchorage, Alaska, 99503, United States

Location

Ironwood Cancer & Research Centers ( Site 0541)

Chandler, Arizona, 85224, United States

Location

CBCC Global Research, Inc. ( Site 0532)

Bakersfield, California, 93309, United States

Location

Scripps Cancer Center ( Site 0521)

La Jolla, California, 92037, United States

Location

Florida Hospital ( Site 0526)

Orlando, Florida, 32803, United States

Location

Northwest Georgia Oncology Centers PC ( Site 0518)

Marietta, Georgia, 30060, United States

Location

Illinois Cancer Care, PC ( Site 0557)

Peoria, Illinois, 61615, United States

Location

Parkview Cancer Center ( Site 0542)

Fort Wayne, Indiana, 46845, United States

Location

University of Kentucky School of Medicine & Hospitals ( Site 0517)

Lexington, Kentucky, 40536, United States

Location

Anne Arundel Medical Center Oncology and Hematology ( Site 0514)

Annapolis, Maryland, 21401, United States

Location

Munson Medical Center ( Site 0512)

Traverse City, Michigan, 49684, United States

Location

Park Nicollet Frauenshuh Cancer Center ( Site 0554)

Saint Louis Park, Minnesota, 55426, United States

Location

University of Missouri Health Care ( Site 0555)

Columbia, Missouri, 65212, United States

Location

Billings Clinic Cancer Center ( Site 0508)

Billings, Montana, 59101, United States

Location

Cone Health Cancer Center at Alamance Regional ( Site 0527)

Greensboro, North Carolina, 27403, United States

Location

Genesis Cancer Care Center ( Site 0559)

Zanesville, Ohio, 43701, United States

Location

Oregon Health Sciences University ( Site 0544)

Portland, Oregon, 97239, United States

Location

Central Texas Veterans Healthcare System ( Site 0533)

Temple, Texas, 76504, United States

Location

Orange Health Services ( Site 0002)

Orange, New South Wales, 2800, Australia

Location

Wollongong Private Hospital ( Site 0005)

Wollongong, New South Wales, 2500, Australia

Location

The Prince Charles Hospital ( Site 0011)

Chermside, Queensland, 4032, Australia

Location

Ballarat Oncology and Haematology Services ( Site 0008)

Wendouree, Victoria, 3355, Australia

Location

St John of God Murdoch Medical Clinic ( Site 0001)

Perth, Western Australia, 6150, Australia

Location

Cross Cancer Institute ( Site 0400)

Edmonton, Alberta, T6G 1Z2, Canada

Location

Lions Gate Hospital ( Site 0407)

North Vancouver, British Columbia, V7L 2L7, Canada

Location

William Osler Health System (Brampton Civic Hospital) ( Site 0402)

Brampton, Ontario, L6R 3J7, Canada

Location

Windsor Regional Cancer Program ( Site 0404)

Windsor, Ontario, N8W 2X3, Canada

Location

McGill University Health Centre ( Site 0418)

Montreal, Quebec, H4A 3J1, Canada

Location

Beijing Chest Hospital Capital Medical University ( Site 0111)

Beijing, Anhui, 101149, China

Location

Anhui Provincial Hospital ( Site 0108)

Hefei, Anhui, 230001, China

Location

The First Affiliated Hospital of Anhui Medical University ( Site 0113)

Hefei, Anhui, 230088, China

Location

Peking Union Medical College Hospital ( Site 0105)

Beijing, Beijing Municipality, 100006, China

Location

Beijing Cancer Hospital ( Site 0102)

Beijing, Beijing Municipality, 100036, China

Location

Xiangya Hospital of Central South University ( Site 0115)

Changsha, Hunan, 410008, China

Location

Hunan Cancer Hospital ( Site 0104)

Changsha, Hunan, 410013, China

Location

Jiangsu Cancer Hospital ( Site 0101)

Nanjing, Jiangsu, 210009, China

Location

The First Hospital of Jilin University ( Site 0110)

Changchun, Jilin, 130021, China

Location

Zhongshan Hospital Fudan University ( Site 0100)

Shanghai, Shanghai Municipality, 200433, China

Location

Shanghai Chest Hospital ( Site 0112)

Shanghai, Shanghai Municipality, 230000, China

Location

1st Affil Hosp of Med College of Xi'an Jiaotong University ( Site 0103)

XiAn, Shanxi, 710061, China

Location

West China Hospital of Sichuan University ( Site 0117)

Chengdu, Sichuan, 510115, China

Location

The First Affiliated Hospital Zhejiang University ( Site 0106)

Hangzhou, Zhejiang, 310003, China

Location

Hangzhou First People's Hospital ( Site 0109)

Hangzhou, Zhejiang, 310006, China

Location

2nd Affil Hosp of Zhejiang University College of Medicine ( Site 0114)

Hangzhou, Zhejiang, 310009, China

Location

Zhejiang Cancer Hospital ( Site 0116)

Hangzhou, Zhejiang, 310022, China

Location

Hospital General de Medellin Luz Castro de Gutierrez ( Site 0368)

Medellín, Antioquia, 050015, Colombia

Location

Fundacion Centro de Investigacion Clinica CIC ( Site 0366)

Medellín, Antioquia, 050021, Colombia

Location

Biomelab S A S ( Site 0365)

Barranquilla, Atlántico, 080002, Colombia

Location

Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0374)

Valledupar, Cesar Department, 200001, Colombia

Location

Oncomedica S.A. ( Site 0372)

Montería, Departamento de Córdoba, 230002, Colombia

Location

Centro Medico Imbanaco de Cali S.A ( Site 0369)

Cali, Valle del Cauca Department, 760023, Colombia

Location

AS Ida-Tallinna Keskhaigla ( Site 0161)

Tallinn, Harju, 11312, Estonia

Location

SA Pohja-Eesti Regionaalhaigla ( Site 0162)

Tallinn, Harju, 13419, Estonia

Location

SA Tartu Ulikooli Kliinikum ( Site 0160)

Tartu, Tartu, 50406, Estonia

Location

CHU Jean Minjoz ( Site 0167)

Besançon, Doubs, 25000, France

Location

Institut Curie - Centre Rene Huguenin ( Site 0181)

Saint-Cloud, Hauts-de-Seine, 92210, France

Location

ICM Val D Auerelle ( Site 0177)

Montpellier, Herault, 34090, France

Location

CHU de Grenoble - Hopital Michallon ( Site 0169)

La Tronche, Isere, 38700, France

Location

Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0185)

Saint-Herblain, Loire-Atlantique, 44805, France

Location

Centre Hospitalier de la Cote Basque ( Site 0173)

Bayonne, Pyrenees-Atlantiques, 64109, France

Location

CHU de Rouen ( Site 0174)

Rouen, Seine-Maritime, 76000, France

Location

CHU Amiens Sud ( Site 0182)

Amiens, Somme, 80054, France

Location

Centre hospitalier Toulon Sainte-Musse ( Site 0172)

Toulon, Var, 83056, France

Location

Institut Curie ( Site 0166)

Paris, 75248, France

Location

Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 0207)

Gyula, Bekes County, 5700, Hungary

Location

Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz ( Site 0202)

Miskolc, Borsod-Abauj Zemplen county, 3529, Hungary

Location

CRU Hungary KFT ( Site 0209)

Miskolc, Borsod-Abauj Zemplen county, 3529, Hungary

Location

Petz Aladar Megyei Oktato Korhaz ( Site 0213)

Győr, Győr-Moson-Sopron, 9024, Hungary

Location

Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0203)

Szolnok, Jász-Nagykun-Szolnok, 5000, Hungary

Location

Tudogyogyintezet Torokbalint ( Site 0205)

Törökbálint, Pest County, 2045, Hungary

Location

Semmelweis Egyetem ( Site 0210)

Budapest, 1083, Hungary

Location

Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 0217)

Kaposvár, 7400, Hungary

Location

Bnei Zion Medical Center ( Site 0227)

Haifa, Heifa, 3339419, Israel

Location

Sheba Medical Center ( Site 0220)

Ramat Gan, Tel Aviv, 5266202, Israel

Location

Soroka Medical Center ( Site 0222)

Beersheba, 8457108, Israel

Location

Rambam Medical Center ( Site 0223)

Haifa, 3109601, Israel

Location

Meir Medical Center ( Site 0221)

Kfar Saba, 4428132, Israel

Location

Rabin Medical Center ( Site 0224)

Petah Tikva, 4941492, Israel

Location

Sourasky Medical Center ( Site 0225)

Tel Aviv, 6423906, Israel

Location

Barzilai Medical Center ( Site 0226)

Ashkelon, Ḥeifā, 7830604, Israel

Location

Azienda Ospedaliera S. Giovanni Addolorata-Oncologia Medica ( Site 0233)

Rome, Lazio, 00185, Italy

Location

Presidio Ospedaliero San Vincenzo ( Site 0231)

Taormina, Messina, 98039, Italy

Location

Centro di Riferimento Oncologico CRO ( Site 0235)

Aviano, Pordenone, 33081, Italy

Location

Azienda Ospedaliera San Giuseppe Moscati ( Site 0234)

Avellino, 83100, Italy

Location

Universita Magna Grecia ( Site 0230)

Catanzaro, 88100, Italy

Location

A.O. Universitaria Careggi ( Site 0236)

Florence, 50134, Italy

Location

Ospedale Santa Maria delle Croci ( Site 0232)

Ravenna, 48121, Italy

Location

Policlinico Gemelli di Roma ( Site 0237)

Roma, 00168, Italy

Location

Aichi Cancer Center Hospital ( Site 0018)

Nagoya, Aichi-ken, 464-8681, Japan

Location

Kurume University Hospital ( Site 0025)

Kurume, Fukuoka, 830-0011, Japan

Location

Hyogo Cancer Center ( Site 0021)

Akashi, Hyōgo, 673-8558, Japan

Location

Kanagawa Cardiovascular and Respiratory Center ( Site 0026)

Yokohama, Kanagawa, 236-0051, Japan

Location

Kanagawa Cancer Center ( Site 0023)

Yokohama, Kanagawa, 241-8515, Japan

Location

Miyagi Cancer Center ( Site 0028)

Natori-shi, Miyagi, 981-1293, Japan

Location

Sendai Kousei Hospital ( Site 0022)

Sendai, Miyagi, 980-0873, Japan

Location

National Hospital Organization Kinki-chuo Chest Medical Center ( Site 0027)

Sakai, Osaka, 591-8555, Japan

Location

Kindai University Hospital ( Site 0017)

Sayama, Osaka, 589-8511, Japan

Location

National Hospital Organization Kyushu Medical Center ( Site 0015)

Fukuoka, 810-8563, Japan

Location

Kyushu University Hospital ( Site 0030)

Fukuoka, 812-8582, Japan

Location

Okayama University Hospital ( Site 0020)

Okayama, 700-8558, Japan

Location

Osaka International Cancer Institute ( Site 0019)

Osaka, 541-8567, Japan

Location

Toranomon Hospital ( Site 0016)

Tokyo, 105-8470, Japan

Location

Juntendo University Hospital ( Site 0029)

Tokyo, 113-8431, Japan

Location

Nippon Medical School Hospital ( Site 0024)

Tokyo, 113-8603, Japan

Location

Hospital Tengku Ampuan Afzan ( Site 0062)

Kuantan, Pahang, 25100, Malaysia

Location

Hospital Pulau Pinang. ( Site 0065)

George Town, Pulau Pinang, 10990, Malaysia

Location

Institut Kanser Negara - National Cancer Institute ( Site 0063)

Putrajaya, Putrajaya, 62250, Malaysia

Location

Sarawak General Hospital ( Site 0064)

Kuching, Sarawak, 93586, Malaysia

Location

Beacon Hospital Sdn Bhd ( Site 0067)

Petaling Jaya, Selangor, 46050, Malaysia

Location

University Malaya Medical Centre ( Site 0061)

Kuala Lumpur, 59100, Malaysia

Location

Gleneagles Penang ( Site 0066)

Pulau Pinang, 10050, Malaysia

Location

Consultorios de Medicina Especializada del Sector Privado ( Site 0388)

Guadalajara, Jalisco, 44680, Mexico

Location

Medica Sur S.A.B de C.V. ( Site 0384)

Mexico City, Mexico City, 14050, Mexico

Location

Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 0381)

Madero, Tamaulipas, 89440, Mexico

Location

Instituto Nacional de Cancerologia. ( Site 0382)

Mexico City, 14080, Mexico

Location

Oaxaca Site Management Organization SC ( Site 0389)

Oaxaca City, 68000, Mexico

Location

Ars Medical Sp. z o.o. ( Site 0254)

Piła, Greater Poland Voivodeship, 64-920, Poland

Location

Krakowski Szpital Specjalistyczny im Jana Pawla II ( Site 0253)

Krakow, Lesser Poland Voivodeship, 31-202, Poland

Location

Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 0243)

Krakow, Lesser Poland Voivodeship, 31-826, Poland

Location

Szpital Uniwersytecki im. Karola Marcinkowskiego ( Site 0247)

Zielona Góra, Lubusz Voivodeship, 65-046, Poland

Location

Centrum Medyczne Pratia Ostroleka ( Site 0242)

Ostrołęka, Masovian Voivodeship, 07-410, Poland

Location

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0252)

Warsaw, Masovian Voivodeship, 02-781, Poland

Location

Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 0250)

Przemyśl, Podkarpackie Voivodeship, 37-700, Poland

Location

SPZOZ USK nr 1 im. Norberta Barlickiego UM w Lodzi ( Site 0256)

Lodz, Łódź Voivodeship, 99-153, Poland

Location

Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 0262)

Ufa, Baskortostan, Respublika, 450054, Russia

Location

Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0266)

Krasnoyarsk, Krasnoyarsk Krai, 660133, Russia

Location

SBHI Samara Regional Clinical Oncology Dispensary ( Site 0265)

Samara, Samara Oblast, 443031, Russia

Location

SBHI Leningrad Regional Clinical Hospital ( Site 0263)

Saint Petersburg, Sankt-Peterburg, 194291, Russia

Location

Railway Hospital of OJSC ( Site 0268)

Saint Petersburg, Sankt-Peterburg, 195271, Russia

Location

City Clinical Oncology Center ( Site 0260)

Saint Petersburg, Sankt-Peterburg, 198255, Russia

Location

Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 0269)

Kazan', Tatarstan, Respublika, 420029, Russia

Location

Seoul National University Bundang Hospital ( Site 0075)

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

Location

Chungbuk National University Hospital ( Site 0079)

Cheongju-si, North Chungcheong, 28644, South Korea

Location

Ulsan University Hospital ( Site 0077)

Ulsan, Ulsan-Kwangyokshi, 44033, South Korea

Location

Asan Medical Center ( Site 0076)

Seoul, 05505, South Korea

Location

SMG-SNU Boramae Medical Center ( Site 0078)

Seoul, 07061, South Korea

Location

National Taiwan University Hospital Hsin-Chu Branch ( Site 0087)

Hsinchu, 300, Taiwan

Location

Taipei Medical University Shuang Ho Hospital ( Site 0090)

New Taipei City, 235, Taiwan

Location

National Cheng Kung University Hospital ( Site 0086)

Tainan, 70457, Taiwan

Location

National Taiwan University Hospital ( Site 0088)

Taipei, 10002, Taiwan

Location

Koo Foundation Sun Yat-Sen Cancer Center ( Site 0091)

Taipei, 112, Taiwan

Location

Taipei Veterans General Hospital ( Site 0089)

Taipei, 112, Taiwan

Location

Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 0321)

Konya, Adana, 42080, Turkey (Türkiye)

Location

Gulhane Egitim ve Arastirma Hastanesi ( Site 0316)

Ankara, 06010, Turkey (Türkiye)

Location

Abdurrahman Yurtaslan Onkoloji Hastanesi ( Site 0318)

Ankara, 06200, Turkey (Türkiye)

Location

Baskent Universitesi Ankara Hastanesi ( Site 0319)

Ankara, 06490, Turkey (Türkiye)

Location

Antalya Memorial Hospital Department of Medical Oncology ( Site 0324)

Antalya, 07020, Turkey (Türkiye)

Location

Akdeniz Universitesi Tip Fakultesi ( Site 0322)

Antalya, 07070, Turkey (Türkiye)

Location

Dokuz Eylul Universitesi Arastirma Uygulama Hastanesi ( Site 0314)

Izmir, 35340, Turkey (Türkiye)

Location

Sakarya Universitesi Egitim ve Arastirma Hastanesi ( Site 0323)

Sakarya, 54290, Turkey (Türkiye)

Location

Samsun Medical Park Hastanesi ( Site 0320)

Samsun, 55200, Turkey (Türkiye)

Location

Cherkasy Regional Hospital ( Site 0336)

Cherkasy, Cherkasy Oblast, 18009, Ukraine

Location

City Clinical Hosp.4 of DCC ( Site 0338)

Dnipro, Dnipropetrovsk Oblast, 49102, Ukraine

Location

MI Precarpathian Clinical Oncology Center ( Site 0346)

Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018, Ukraine

Location

Regional Centre of Oncology-Thoracic organs ( Site 0337)

Kharkiv, Kharkivs’ka Oblast’, 61070, Ukraine

Location

Ukranian Center of TomoTherapy ( Site 0344)

Kropyvnytskiy, Kirovohrad Oblast, 25011, Ukraine

Location

Medical Center Verum ( Site 0334)

Kyiv, Kyivska Oblast, 03039, Ukraine

Location

Kyiv City Clinical Oncology Centre ( Site 0339)

Kyiv, Kyivska Oblast, 03115, Ukraine

Location

Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 0331)

Kyiv, Kyivska Oblast, 03126, Ukraine

Location

Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 0341)

Lviv, Lviv Oblast, 79031, Ukraine

Location

MI Odessa Regional Oncological Centre ( Site 0333)

Odesa, Odesa Oblast, 65055, Ukraine

Location

Podillya Regional Center of Oncology ( Site 0343)

Vinnytsia, Vinnytsia Oblast, 21029, Ukraine

Location

Related Publications (2)

• Yang JC, Han B, De La Mora Jimenez E, Lee JS, Koralewski P, Karadurmus N, Sugawara S, Livi L, Basappa NS, Quantin X, Dudnik J, Ortiz DM, Mekhail T, Okpara CE, Dutcus C, Zimmer Z, Samkari A, Bhagwati N, Csoszi T. Pembrolizumab With or Without Lenvatinib for First-Line Metastatic NSCLC With Programmed Cell Death-Ligand 1 Tumor Proportion Score of at least 1% (LEAP-007): A Randomized, Double-Blind, Phase 3 Trial. J Thorac Oncol. 2024 Jun;19(6):941-953. doi: 10.1016/j.jtho.2023.12.023. Epub 2023 Dec 29.

  PMID: 38159809 RESULT

• Taylor MH, Schmidt EV, Dutcus C, Pinheiro EM, Funahashi Y, Lubiniecki G, Rasco D. The LEAP program: lenvatinib plus pembrolizumab for the treatment of advanced solid tumors. Future Oncol. 2021 Feb;17(6):637-648. doi: 10.2217/fon-2020-0937. Epub 2020 Dec 10.

  PMID: 33300372 DERIVED

Related Links

• Merck Clinical Trial Information
• Plain Language Summary

MeSH Terms

Conditions

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

Interventions

pembrolizumab; lenvatinib

Condition Hierarchy (Ancestors)

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

Results Point of Contact

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

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2019
• First Posted: February 4, 2019
• Study Start: March 13, 2019
• Primary Completion: May 19, 2021
• Study Completion: April 24, 2024
• Last Updated: February 19, 2026
• Results First Posted: June 2, 2022

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

KR (5); TU (9); FR (10); ME (5); CA (5); HU (8); JP (16); AU (5); RU (7); CO (6); MY (7); UA (11); ES (3); TW (6); US (18); PL (8); CN (17); IT (8); IL (8)