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).
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.
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.
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There are 155 Locations for this study
Anchorage Alaska, 99503, United States
Chandler Arizona, 85224, United States
Bakersfield California, 93309, United States
La Jolla California, 92037, United States
Orlando Florida, 32803, United States
Marietta Georgia, 30060, United States
Peoria Illinois, 61615, United States
Fort Wayne Indiana, 46845, United States
Lexington Kentucky, 40536, United States
Annapolis Maryland, 21401, United States
Traverse City Michigan, 49684, United States
Saint Louis Park Minnesota, 55426, United States
Columbia Missouri, 65212, United States
Billings Montana, 59101, United States
Greensboro North Carolina, 27403, United States
Zanesville Ohio, 43701, United States
Portland Oregon, 97239, United States
Temple Texas, 76504, United States
Orange New South Wales, 2800, Australia
Wollongong New South Wales, 2500, Australia
Chermside Queensland, 4032, Australia
Wendouree Victoria, 3355, Australia
Perth Western Australia, 6150, Australia
Edmonton Alberta, T6G 1, Canada
North Vancouver British Columbia, V7L 2, Canada
Brampton Ontario, L6R 3, Canada
Windsor Ontario, N8W 2, Canada
Montreal Quebec, H4A 3, Canada
Beijing Anhui, 10114, China
Hefei Anhui, 23000, China
Hefei Anhui, 23008, China
Beijing Beijing, 10000, China
Beijing Beijing, 10003, China
Changsha Hunan, 41000, China
Changsha Hunan, 41001, China
Nanjing Jiangsu, 21000, China
Chang chun Jilin, 13002, China
Shanghai Shanghai, 20043, China
Shanghai Shanghai, 23000, China
XiAn Shanxi, 71006, China
Chengdu Sichuan, 51011, China
Hangzhou Zhejiang, 31000, China
Hangzhou Zhejiang, 31000, China
Hangzhou Zhejiang, 31000, China
Hangzhou Zhejiang, 31002, China
Medellin Antioquia, 05001, Colombia
Medellin Antioquia, 05002, Colombia
Barranquilla Atlantico, 08000, Colombia
Valledupar Cesar, 20000, Colombia
Monteria Cordoba, 23000, Colombia
Cali Valle Del Cauca, 76002, Colombia
Tallinn Harjumaa, 11312, Estonia
Tallin Harjumaa, 13419, Estonia
Tartu Tartumaa, 50406, Estonia
Besancon Doubs, 25000, France
Saint-Cloud Hauts-de-Seine, 92210, France
Montpellier Herault, 34090, France
La Tronche Isere, 38700, France
Saint Herblain Loire-Atlantique, 44805, France
Bayonne Pyrenees-Atlantiques, 64109, France
Rouen Seine-Maritime, 76000, France
Amiens Somme, 80054, France
Toulon Var, 83056, France
Paris , 75248, France
Gyula Bekes, 5700, Hungary
Miskolc Borsod-Abauj-Zemplen, 3529, Hungary
Miskolc Borsod-Abauj-Zemplen, 3529, Hungary
Gyor Gyor-Moson-Sopron, 9024, Hungary
Szolnok Jasz-Nagykun-Szolnok, 5000, Hungary
Torokbalint Pest, 2045, Hungary
Budapest , 1083, Hungary
Kaposvar , 7400, Hungary
Haifa Heifa, 33394, Israel
Ramat Gan Tel Aviv, 52662, Israel
Beer Sheva , 84571, Israel
Haifa , 31096, Israel
Kfar-Saba , 44281, Israel
Petah Tikva , 49414, Israel
Tel Aviv , 64239, Israel
Ashkelon Ḥeifā, 78306, Israel
Roma Lazio, 00185, Italy
Taormina Messina, 98039, Italy
Aviano Pordenone, 33081, Italy
Avellino , 83100, Italy
Catanzaro , 88100, Italy
Firenze , 50134, Italy
Ravenna , 48121, Italy
Roma , 00168, Italy
Nagoya Aichi, 464-8, Japan
Kurume Fukuoka, 830-0, Japan
Akashi Hyogo, 673-8, Japan
Yokohama Kanagawa, 236-0, Japan
Yokohama Kanagawa, 241-8, Japan
Natori Miyagi, 981-1, Japan
Sendai Miyagi, 980-0, Japan
Osakasayama Osaka, 589-8, Japan
Sakai Osaka, 591-8, Japan
Fukuoka , 810-8, Japan
Fukuoka , 812-8, Japan
Okayama , 700-8, Japan
Osaka , 541-8, Japan
Tokyo , 105-8, Japan
Tokyo , 113-8, Japan
Tokyo , 113-8, Japan
Cheongju si Chungbuk, 28644, Korea, Republic of
Seongnam-si Kyonggi-do, 13620, Korea, Republic of
Ulsan Ulsan-Kwangyokshi, 44033, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 07061, Korea, Republic of
Kuantan Pahang, 25100, Malaysia
Georgetown Pulau Pinang, 10990, Malaysia
Kuching Sarawak, 93586, Malaysia
Petaling Jaya Selangor, 46050, Malaysia
Putrajaya Wilayah Persekutuan Putrajaya, 62250, Malaysia
Kuala Lumpur , 59100, Malaysia
Pulau Pinang , 10050, Malaysia
Mexico City Distrito Federal, 14050, Mexico
Guadalajara Jalisco, 44680, Mexico
Madero Tamaulipas, 89440, Mexico
Mexico City , 14080, Mexico
Oaxaca , 68000, Mexico
Lodz Lodzkie, 99-15, Poland
Zielona Gora Lubuskie, 65-04, Poland
Krakow Malopolskie, 31-20, Poland
Krakow Malopolskie, 31-82, Poland
Ostroleka Mazowieckie, 07-41, Poland
Warszawa Mazowieckie, 02-78, Poland
Przemysl Podkarpackie, 37-70, Poland
Pila Wielkopolskie, 64-92, Poland
Ufa Baskortostan, Respublika, 45005, Russian Federation
Krasnoyarsk Krasnoyarskiy Kray, 66013, Russian Federation
Samara Samarskaya Oblast, 44303, Russian Federation
Saint Petersburg Sankt-Peterburg, 19429, Russian Federation
Saint Petersburg Sankt-Peterburg, 19527, Russian Federation
Saint Petersburg Sankt-Peterburg, 19825, Russian Federation
Kazan Tatarstan, Respublika, 42002, Russian Federation
Hsinchu , 300, Taiwan
New Taipei , 235, Taiwan
Tainan , 70457, Taiwan
Taipei , 10002, Taiwan
Taipei , 112, Taiwan
Taipei , 112, Taiwan
Konya Adana, 42080, Turkey
Ankara , 06010, Turkey
Ankara , 06200, Turkey
Ankara , 06490, Turkey
Antalya , 07020, Turkey
Antalya , 07070, Turkey
Izmir , 35340, Turkey
Sakarya , 54290, Turkey
Samsun , 55200, Turkey
Cherkasy Cherkaska Oblast, 18009, Ukraine
Dnipro Dnipropetrovska Oblast, 49102, Ukraine
Ivano-Frankivsk Ivano-Frankivska Oblast, 76018, Ukraine
Kharkiv Kharkivska Oblast, 61070, Ukraine
Kropyvnytskiy Kirovohradska Oblast, 25011, Ukraine
Kyiv Kyivska Oblast, 03039, Ukraine
Kyiv Kyivska Oblast, 03115, Ukraine
Kyiv Kyivska Oblast, 03126, Ukraine
Lviv Lvivska Oblast, 79031, Ukraine
Odesa Odeska Oblast, 65055, Ukraine
Vinnytsia Vinnytska Oblast, 21029, Ukraine
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