Lung Cancer Clinical Trial

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)

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).

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Full Description

As of 30-Jul-2021, active participants, investigator, and sponsor personnel or delegate(s) involved in the treatment administration or clinical evaluation of the participants will be unblinded. Participants will discontinue lenvatinib and placebo, and participants who remain on treatment will receive open-label pembrolizumab only.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Has a histologically or cytologically confirmed diagnosis of 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.

Exclusion Criteria:

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.
Has received prior systemic chemotherapy or other targeted or biological antineoplastic therapy for their metastatic NSCLC.
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], Tumor necrosis factor receptor superfamily, member 4 [OX 40], tumor necrosis factor receptor superfamily member 9 [CD137]) or has received lenvatinib as monotherapy or in combination with anti- programmed cell death protein (anti-PD-1) agents.
Has received radiotherapy within 14 days before the first dose of study treatment or received lung radiation therapy of >30 Gray (Gy) within 6 months before the first dose of study treatment. (Note: Participants must have recovered from all radiation-related toxicities to ≤Grade 1, not require corticosteroids, and not have had radiation pneumonitis.)
Has a diagnosis of immunodeficiency or is receiving any form of immunosuppressive therapy within 7 days before the first dose of study treatment.
Is receiving systemic steroid therapy (doses >10 mg daily of prednisone equivalent) within 7 days before the first dose of study treatment.
Has received a live or attenuated vaccine within 30 days before the first dose of study treatment.
Has had major surgery within 3 weeks prior to first dose of study treatment
Has pre-existing ≥Grade 3 gastrointestinal or nongastrointestinal fistula.

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

623

Study ID:

NCT03829332

Recruitment Status:

Active, not recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 155 Locations for this study

See Locations Near You

Alaska Clinical Research Center ( Site 0511)
Anchorage Alaska, 99503, United States
Ironwood Cancer & Research Centers ( Site 0541)
Chandler Arizona, 85224, United States
CBCC Global Research, Inc. ( Site 0532)
Bakersfield California, 93309, United States
Scripps Cancer Center ( Site 0521)
La Jolla California, 92037, United States
Florida Hospital ( Site 0526)
Orlando Florida, 32803, United States
Northwest Georgia Oncology Centers PC ( Site 0518)
Marietta Georgia, 30060, United States
Illinois Cancer Care, PC ( Site 0557)
Peoria Illinois, 61615, United States
Parkview Cancer Center ( Site 0542)
Fort Wayne Indiana, 46845, United States
University of Kentucky School of Medicine & Hospitals ( Site 0517)
Lexington Kentucky, 40536, United States
Anne Arundel Medical Center Oncology and Hematology ( Site 0514)
Annapolis Maryland, 21401, United States
Munson Medical Center ( Site 0512)
Traverse City Michigan, 49684, United States
Park Nicollet Frauenshuh Cancer Center ( Site 0554)
Saint Louis Park Minnesota, 55426, United States
University of Missouri Health Care ( Site 0555)
Columbia Missouri, 65212, United States
Billings Clinic Cancer Center ( Site 0508)
Billings Montana, 59101, United States
Cone Health Cancer Center at Alamance Regional ( Site 0527)
Greensboro North Carolina, 27403, United States
Genesis Cancer Care Center ( Site 0559)
Zanesville Ohio, 43701, United States
Oregon Health Sciences University ( Site 0544)
Portland Oregon, 97239, United States
Central Texas Veterans Healthcare System ( Site 0533)
Temple Texas, 76504, United States
Orange Health Services ( Site 0002)
Orange New South Wales, 2800, Australia
Wollongong Private Hospital ( Site 0005)
Wollongong New South Wales, 2500, Australia
The Prince Charles Hospital ( Site 0011)
Chermside Queensland, 4032, Australia
Ballarat Oncology and Haematology Services ( Site 0008)
Wendouree Victoria, 3355, Australia
St John of God Murdoch Medical Clinic ( Site 0001)
Perth Western Australia, 6150, Australia
Cross Cancer Institute ( Site 0400)
Edmonton Alberta, T6G 1, Canada
Lions Gate Hospital ( Site 0407)
North Vancouver British Columbia, V7L 2, Canada
William Osler Health System (Brampton Civic Hospital) ( Site 0402)
Brampton Ontario, L6R 3, Canada
Windsor Regional Cancer Program ( Site 0404)
Windsor Ontario, N8W 2, Canada
McGill University Health Centre ( Site 0418)
Montreal Quebec, H4A 3, Canada
Beijing Chest Hospital Capital Medical University ( Site 0111)
Beijing Anhui, 10114, China
Anhui Provincial Hospital ( Site 0108)
Hefei Anhui, 23000, China
The First Affiliated Hospital of Anhui Medical University ( Site 0113)
Hefei Anhui, 23008, China
Peking Union Medical College Hospital ( Site 0105)
Beijing Beijing, 10000, China
Beijing Cancer Hospital ( Site 0102)
Beijing Beijing, 10003, China
Xiangya Hospital of Central South University ( Site 0115)
Changsha Hunan, 41000, China
Hunan Cancer Hospital ( Site 0104)
Changsha Hunan, 41001, China
Jiangsu Cancer Hospital ( Site 0101)
Nanjing Jiangsu, 21000, China
The First Hospital of Jilin University ( Site 0110)
Chang chun Jilin, 13002, China
Zhongshan Hospital Fudan University ( Site 0100)
Shanghai Shanghai, 20043, China
Shanghai Chest Hospital ( Site 0112)
Shanghai Shanghai, 23000, China
1st Affil Hosp of Med College of Xi'an Jiaotong University ( Site 0103)
XiAn Shanxi, 71006, China
West China Hospital of Sichuan University ( Site 0117)
Chengdu Sichuan, 51011, China
The First Affiliated Hospital Zhejiang University ( Site 0106)
Hangzhou Zhejiang, 31000, China
Hangzhou First People's Hospital ( Site 0109)
Hangzhou Zhejiang, 31000, China
2nd Affil Hosp of Zhejiang University College of Medicine ( Site 0114)
Hangzhou Zhejiang, 31000, China
Zhejiang Cancer Hospital ( Site 0116)
Hangzhou Zhejiang, 31002, China
Hospital General de Medellin Luz Castro de Gutierrez ( Site 0368)
Medellin Antioquia, 05001, Colombia
Fundacion Centro de Investigacion Clinica CIC ( Site 0366)
Medellin Antioquia, 05002, Colombia
Biomelab S A S ( Site 0365)
Barranquilla Atlantico, 08000, Colombia
Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0374)
Valledupar Cesar, 20000, Colombia
Oncomedica S.A. ( Site 0372)
Monteria Cordoba, 23000, Colombia
Centro Medico Imbanaco de Cali S.A ( Site 0369)
Cali Valle Del Cauca, 76002, Colombia
AS Ida-Tallinna Keskhaigla ( Site 0161)
Tallinn Harjumaa, 11312, Estonia
SA Pohja-Eesti Regionaalhaigla ( Site 0162)
Tallin Harjumaa, 13419, Estonia
SA Tartu Ulikooli Kliinikum ( Site 0160)
Tartu Tartumaa, 50406, Estonia
CHU Jean Minjoz ( Site 0167)
Besancon Doubs, 25000, France
Institut Curie - Centre Rene Huguenin ( Site 0181)
Saint-Cloud Hauts-de-Seine, 92210, France
ICM Val D Auerelle ( Site 0177)
Montpellier Herault, 34090, France
CHU de Grenoble - Hopital Michallon ( Site 0169)
La Tronche Isere, 38700, France
Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0185)
Saint Herblain Loire-Atlantique, 44805, France
Centre Hospitalier de la Cote Basque ( Site 0173)
Bayonne Pyrenees-Atlantiques, 64109, France
CHU de Rouen ( Site 0174)
Rouen Seine-Maritime, 76000, France
CHU Amiens Sud ( Site 0182)
Amiens Somme, 80054, France
Centre hospitalier Toulon Sainte-Musse ( Site 0172)
Toulon Var, 83056, France
Institut Curie ( Site 0166)
Paris , 75248, France
Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 0207)
Gyula Bekes, 5700, Hungary
Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz ( Site 0202)
Miskolc Borsod-Abauj-Zemplen, 3529, Hungary
CRU Hungary KFT ( Site 0209)
Miskolc Borsod-Abauj-Zemplen, 3529, Hungary
Petz Aladar Megyei Oktato Korhaz ( Site 0213)
Gyor Gyor-Moson-Sopron, 9024, Hungary
Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0203)
Szolnok Jasz-Nagykun-Szolnok, 5000, Hungary
Tudogyogyintezet Torokbalint ( Site 0205)
Torokbalint Pest, 2045, Hungary
Semmelweis Egyetem ( Site 0210)
Budapest , 1083, Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 0217)
Kaposvar , 7400, Hungary
Bnei Zion Medical Center ( Site 0227)
Haifa Heifa, 33394, Israel
Sheba Medical Center ( Site 0220)
Ramat Gan Tel Aviv, 52662, Israel
Soroka Medical Center ( Site 0222)
Beer Sheva , 84571, Israel
Rambam Medical Center ( Site 0223)
Haifa , 31096, Israel
Meir Medical Center ( Site 0221)
Kfar-Saba , 44281, Israel
Rabin Medical Center ( Site 0224)
Petah Tikva , 49414, Israel
Sourasky Medical Center ( Site 0225)
Tel Aviv , 64239, Israel
Barzilai Medical Center ( Site 0226)
Ashkelon Ḥeifā, 78306, Israel
Azienda Ospedaliera S. Giovanni Addolorata-Oncologia Medica ( Site 0233)
Roma Lazio, 00185, Italy
Presidio Ospedaliero San Vincenzo ( Site 0231)
Taormina Messina, 98039, Italy
Centro di Riferimento Oncologico CRO ( Site 0235)
Aviano Pordenone, 33081, Italy
Azienda Ospedaliera San Giuseppe Moscati ( Site 0234)
Avellino , 83100, Italy
Universita Magna Grecia ( Site 0230)
Catanzaro , 88100, Italy
A.O. Universitaria Careggi ( Site 0236)
Firenze , 50134, Italy
Ospedale Santa Maria delle Croci ( Site 0232)
Ravenna , 48121, Italy
Policlinico Gemelli di Roma ( Site 0237)
Roma , 00168, Italy
Aichi Cancer Center Hospital ( Site 0018)
Nagoya Aichi, 464-8, Japan
Kurume University Hospital ( Site 0025)
Kurume Fukuoka, 830-0, Japan
Hyogo Cancer Center ( Site 0021)
Akashi Hyogo, 673-8, Japan
Kanagawa Cardiovascular and Respiratory Center ( Site 0026)
Yokohama Kanagawa, 236-0, Japan
Kanagawa Cancer Center ( Site 0023)
Yokohama Kanagawa, 241-8, Japan
Miyagi Cancer Center ( Site 0028)
Natori Miyagi, 981-1, Japan
Sendai Kousei Hospital ( Site 0022)
Sendai Miyagi, 980-0, Japan
Kindai University Hospital ( Site 0017)
Osakasayama Osaka, 589-8, Japan
National Hospital Organization Kinki-chuo Chest Medical Center ( Site 0027)
Sakai Osaka, 591-8, Japan
National Hospital Organization Kyushu Medical Center ( Site 0015)
Fukuoka , 810-8, Japan
Kyushu University Hospital ( Site 0030)
Fukuoka , 812-8, Japan
Okayama University Hospital ( Site 0020)
Okayama , 700-8, Japan
Osaka International Cancer Institute ( Site 0019)
Osaka , 541-8, Japan
Toranomon Hospital ( Site 0016)
Tokyo , 105-8, Japan
Juntendo University Hospital ( Site 0029)
Tokyo , 113-8, Japan
Nippon Medical School Hospital ( Site 0024)
Tokyo , 113-8, Japan
Chungbuk National University Hospital ( Site 0079)
Cheongju si Chungbuk, 28644, Korea, Republic of
Seoul National University Bundang Hospital ( Site 0075)
Seongnam-si Kyonggi-do, 13620, Korea, Republic of
Ulsan University Hospital ( Site 0077)
Ulsan Ulsan-Kwangyokshi, 44033, Korea, Republic of
Asan Medical Center ( Site 0076)
Seoul , 05505, Korea, Republic of
SMG-SNU Boramae Medical Center ( Site 0078)
Seoul , 07061, Korea, Republic of
Hospital Tengku Ampuan Afzan ( Site 0062)
Kuantan Pahang, 25100, Malaysia
Hospital Pulau Pinang. ( Site 0065)
Georgetown Pulau Pinang, 10990, Malaysia
Sarawak General Hospital ( Site 0064)
Kuching Sarawak, 93586, Malaysia
Beacon Hospital Sdn Bhd ( Site 0067)
Petaling Jaya Selangor, 46050, Malaysia
Institut Kanser Negara - National Cancer Institute ( Site 0063)
Putrajaya Wilayah Persekutuan Putrajaya, 62250, Malaysia
University Malaya Medical Centre ( Site 0061)
Kuala Lumpur , 59100, Malaysia
Gleneagles Penang ( Site 0066)
Pulau Pinang , 10050, Malaysia
Medica Sur S.A.B de C.V. ( Site 0384)
Mexico City Distrito Federal, 14050, Mexico
Consultorios de Medicina Especializada del Sector Privado ( Site 0388)
Guadalajara Jalisco, 44680, Mexico
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 0381)
Madero Tamaulipas, 89440, Mexico
Instituto Nacional de Cancerologia. ( Site 0382)
Mexico City , 14080, Mexico
Oaxaca Site Management Organization SC ( Site 0389)
Oaxaca , 68000, Mexico
SPZOZ USK nr 1 im. Norberta Barlickiego UM w Lodzi ( Site 0256)
Lodz Lodzkie, 99-15, Poland
Szpital Uniwersytecki im. Karola Marcinkowskiego ( Site 0247)
Zielona Gora Lubuskie, 65-04, Poland
Krakowski Szpital Specjalistyczny im Jana Pawla II ( Site 0253)
Krakow Malopolskie, 31-20, Poland
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 0243)
Krakow Malopolskie, 31-82, Poland
Centrum Medyczne Pratia Ostroleka ( Site 0242)
Ostroleka Mazowieckie, 07-41, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0252)
Warszawa Mazowieckie, 02-78, Poland
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 0250)
Przemysl Podkarpackie, 37-70, Poland
Ars Medical Sp. z o.o. ( Site 0254)
Pila Wielkopolskie, 64-92, Poland
Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 0262)
Ufa Baskortostan, Respublika, 45005, Russian Federation
Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0266)
Krasnoyarsk Krasnoyarskiy Kray, 66013, Russian Federation
SBHI Samara Regional Clinical Oncology Dispensary ( Site 0265)
Samara Samarskaya Oblast, 44303, Russian Federation
SBHI Leningrad Regional Clinical Hospital ( Site 0263)
Saint Petersburg Sankt-Peterburg, 19429, Russian Federation
Railway Hospital of OJSC ( Site 0268)
Saint Petersburg Sankt-Peterburg, 19527, Russian Federation
City Clinical Oncology Center ( Site 0260)
Saint Petersburg Sankt-Peterburg, 19825, Russian Federation
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 0269)
Kazan Tatarstan, Respublika, 42002, Russian Federation
National Taiwan University Hospital Hsin-Chu Branch ( Site 0087)
Hsinchu , 300, Taiwan
Taipei Medical University Shuang Ho Hospital ( Site 0090)
New Taipei , 235, Taiwan
National Cheng Kung University Hospital ( Site 0086)
Tainan , 70457, Taiwan
National Taiwan University Hospital ( Site 0088)
Taipei , 10002, Taiwan
Koo Foundation Sun Yat-Sen Cancer Center ( Site 0091)
Taipei , 112, Taiwan
Taipei Veterans General Hospital ( Site 0089)
Taipei , 112, Taiwan
Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 0321)
Konya Adana, 42080, Turkey
Gulhane Egitim ve Arastirma Hastanesi ( Site 0316)
Ankara , 06010, Turkey
Abdurrahman Yurtaslan Onkoloji Hastanesi ( Site 0318)
Ankara , 06200, Turkey
Baskent Universitesi Ankara Hastanesi ( Site 0319)
Ankara , 06490, Turkey
Antalya Memorial Hospital Department of Medical Oncology ( Site 0324)
Antalya , 07020, Turkey
Akdeniz Universitesi Tip Fakultesi ( Site 0322)
Antalya , 07070, Turkey
Dokuz Eylul Universitesi Arastirma Uygulama Hastanesi ( Site 0314)
Izmir , 35340, Turkey
Sakarya Universitesi Egitim ve Arastirma Hastanesi ( Site 0323)
Sakarya , 54290, Turkey
Samsun Medical Park Hastanesi ( Site 0320)
Samsun , 55200, Turkey
Cherkasy Regional Hospital ( Site 0336)
Cherkasy Cherkaska Oblast, 18009, Ukraine
City Clinical Hosp.4 of DCC ( Site 0338)
Dnipro Dnipropetrovska Oblast, 49102, Ukraine
MI Precarpathian Clinical Oncology Center ( Site 0346)
Ivano-Frankivsk Ivano-Frankivska Oblast, 76018, Ukraine
Regional Centre of Oncology-Thoracic organs ( Site 0337)
Kharkiv Kharkivska Oblast, 61070, Ukraine
Ukranian Center of TomoTherapy ( Site 0344)
Kropyvnytskiy Kirovohradska Oblast, 25011, Ukraine
Medical Center Verum ( Site 0334)
Kyiv Kyivska Oblast, 03039, Ukraine
Kyiv City Clinical Oncology Centre ( Site 0339)
Kyiv Kyivska Oblast, 03115, Ukraine
Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 0331)
Kyiv Kyivska Oblast, 03126, Ukraine
Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 0341)
Lviv Lvivska Oblast, 79031, Ukraine
MI Odessa Regional Oncological Centre ( Site 0333)
Odesa Odeska Oblast, 65055, Ukraine
Podillya Regional Center of Oncology ( Site 0343)
Vinnytsia Vinnytska Oblast, 21029, Ukraine

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

623

Study ID:

NCT03829332

Recruitment Status:

Active, not recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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