AzTrials
AzTrials

Non-small Cell Lung CancerPhase 3NCT03829332

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)

A Phase 3 study testing Pembrolizumab and Lenvatinib in people with Non-small Cell Lung Cancer, run by Merck Sharp & Dohme LLC at 162 sites in 19 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

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
Pembrolizumab and Lenvatinib
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
623 participants
Where
162 sitesin 19 countries
Study dates
13 Mar 2019to 24 Apr 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 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

162 sites in 19 countries.

162 sites in 19 countries

United States18 sites

  • Alaska Clinical Research Center ( Site 0511)

    Anchorage, Alaska, 99503

  • Anne Arundel Medical Center Oncology and Hematology ( Site 0514)

    Annapolis, Maryland, 21401

  • CBCC Global Research, Inc. ( Site 0532)

    Bakersfield, California, 93309

  • Billings Clinic Cancer Center ( Site 0508)

    Billings, Montana, 59101

  • Ironwood Cancer & Research Centers ( Site 0541)

    Chandler, Arizona, 85224

  • University of Missouri Health Care ( Site 0555)

    Columbia, Missouri, 65212

  • Parkview Cancer Center ( Site 0542)

    Fort Wayne, Indiana, 46845

  • Cone Health Cancer Center at Alamance Regional ( Site 0527)

    Greensboro, North Carolina, 27403

  • Scripps Cancer Center ( Site 0521)

    La Jolla, California, 92037

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

    Lexington, Kentucky, 40536

  • Northwest Georgia Oncology Centers PC ( Site 0518)

    Marietta, Georgia, 30060

  • Florida Hospital ( Site 0526)

    Orlando, Florida, 32803

  • Illinois Cancer Care, PC ( Site 0557)

    Peoria, Illinois, 61615

  • Oregon Health Sciences University ( Site 0544)

    Portland, Oregon, 97239

  • Park Nicollet Frauenshuh Cancer Center ( Site 0554)

    Saint Louis Park, Minnesota, 55426

  • Central Texas Veterans Healthcare System ( Site 0533)

    Temple, Texas, 76504

  • Munson Medical Center ( Site 0512)

    Traverse City, Michigan, 49684

  • Genesis Cancer Care Center ( Site 0559)

    Zanesville, Ohio, 43701

Other trials in United States

China17 sites

  • Beijing Chest Hospital Capital Medical University ( Site 0111)

    Beijing, Anhui, 101149

  • Peking Union Medical College Hospital ( Site 0105)

    Beijing, Beijing Municipality, 100006

  • Beijing Cancer Hospital ( Site 0102)

    Beijing, Beijing Municipality, 100036

  • The First Hospital of Jilin University ( Site 0110)

    Changchun, Jilin, 130021

  • Xiangya Hospital of Central South University ( Site 0115)

    Changsha, Hunan, 410008

  • Hunan Cancer Hospital ( Site 0104)

    Changsha, Hunan, 410013

  • West China Hospital of Sichuan University ( Site 0117)

    Chengdu, Sichuan, 510115

  • The First Affiliated Hospital Zhejiang University ( Site 0106)

    Hangzhou, Zhejiang, 310003

  • Hangzhou First People's Hospital ( Site 0109)

    Hangzhou, Zhejiang, 310006

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

    Hangzhou, Zhejiang, 310009

  • Zhejiang Cancer Hospital ( Site 0116)

    Hangzhou, Zhejiang, 310022

  • Anhui Provincial Hospital ( Site 0108)

    Hefei, Anhui, 230001

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

    Hefei, Anhui, 230088

  • Jiangsu Cancer Hospital ( Site 0101)

    Nanjing, Jiangsu, 210009

  • Zhongshan Hospital Fudan University ( Site 0100)

    Shanghai, Shanghai Municipality, 200433

  • Shanghai Chest Hospital ( Site 0112)

    Shanghai, Shanghai Municipality, 230000

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

    XiAn, Shanxi, 710061

Other trials in China

Japan16 sites

  • Hyogo Cancer Center ( Site 0021)

    Akashi, Hyōgo, 673-8558

  • National Hospital Organization Kyushu Medical Center ( Site 0015)

    Fukuoka, 810-8563

  • Kyushu University Hospital ( Site 0030)

    Fukuoka, 812-8582

  • Kurume University Hospital ( Site 0025)

    Kurume, Fukuoka, 830-0011

  • Aichi Cancer Center Hospital ( Site 0018)

    Nagoya, Aichi-ken, 464-8681

  • Miyagi Cancer Center ( Site 0028)

    Natori-shi, Miyagi, 981-1293

  • Okayama University Hospital ( Site 0020)

    Okayama, 700-8558

  • Osaka International Cancer Institute ( Site 0019)

    Osaka, 541-8567

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

    Sakai, Osaka, 591-8555

  • Kindai University Hospital ( Site 0017)

    Sayama, Osaka, 589-8511

  • Sendai Kousei Hospital ( Site 0022)

    Sendai, Miyagi, 980-0873

  • Toranomon Hospital ( Site 0016)

    Tokyo, 105-8470

  • Juntendo University Hospital ( Site 0029)

    Tokyo, 113-8431

  • Nippon Medical School Hospital ( Site 0024)

    Tokyo, 113-8603

  • Kanagawa Cardiovascular and Respiratory Center ( Site 0026)

    Yokohama, Kanagawa, 236-0051

  • Kanagawa Cancer Center ( Site 0023)

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

Ukraine11 sites

  • Cherkasy Regional Hospital ( Site 0336)

    Cherkasy, Cherkasy Oblast, 18009

  • City Clinical Hosp.4 of DCC ( Site 0338)

    Dnipro, Dnipropetrovsk Oblast, 49102

  • MI Precarpathian Clinical Oncology Center ( Site 0346)

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018

  • Regional Centre of Oncology-Thoracic organs ( Site 0337)

    Kharkiv, Kharkiv Oblast, 61070

  • Ukranian Center of TomoTherapy ( Site 0344)

    Kropyvnytskiy, Kirovohrad Oblast, 25011

  • Medical Center Verum ( Site 0334)

    Kyiv, Kyivska Oblast, 03039

  • Kyiv City Clinical Oncology Centre ( Site 0339)

    Kyiv, Kyivska Oblast, 03115

  • Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 0331)

    Kyiv, Kyivska Oblast, 03126

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

    Lviv, Lviv Oblast, 79031

  • MI Odessa Regional Oncological Centre ( Site 0333)

    Odesa, Odesa Oblast, 65055

  • Podillya Regional Center of Oncology ( Site 0343)

    Vinnytsia, Vinnytsia Oblast, 21029

Other trials in Ukraine

France10 sites

  • CHU Amiens Sud ( Site 0182)

    Amiens, Somme, 80054

  • Centre Hospitalier de la Cote Basque ( Site 0173)

    Bayonne, Pyrenees-Atlantiques, 64109

  • CHU Jean Minjoz ( Site 0167)

    Besançon, Doubs, 25000

  • CHU de Grenoble - Hopital Michallon ( Site 0169)

    La Tronche, Isere, 38700

  • ICM Val D Auerelle ( Site 0177)

    Montpellier, Herault, 34090

  • Institut Curie ( Site 0166)

    Paris, 75248

  • CHU de Rouen ( Site 0174)

    Rouen, Seine-Maritime, 76000

  • Institut Curie - Centre Rene Huguenin ( Site 0181)

    Saint-Cloud, Hauts-de-Seine, 92210

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

    Saint-Herblain, Loire-Atlantique, 44805

  • Centre hospitalier Toulon Sainte-Musse ( Site 0172)

    Toulon, Var, 83056

Other trials in France

Turkey (Türkiye)9 sites

  • Gulhane Egitim ve Arastirma Hastanesi ( Site 0316)

    Ankara, 06010

  • Abdurrahman Yurtaslan Onkoloji Hastanesi ( Site 0318)

    Ankara, 06200

  • Baskent Universitesi Ankara Hastanesi ( Site 0319)

    Ankara, 06490

  • Antalya Memorial Hospital Department of Medical Oncology ( Site 0324)

    Antalya, 07020

  • Akdeniz Universitesi Tip Fakultesi ( Site 0322)

    Antalya, 07070

  • Dokuz Eylul Universitesi Arastirma Uygulama Hastanesi ( Site 0314)

    Izmir, 35340

  • Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 0321)

    Konya, Adana, 42080

  • Sakarya Universitesi Egitim ve Arastirma Hastanesi ( Site 0323)

    Sakarya, 54290

  • Samsun Medical Park Hastanesi ( Site 0320)

    Samsun, 55200

Other trials in Turkey (Türkiye)

Hungary8 sites

  • Semmelweis Egyetem ( Site 0210)

    Budapest, 1083

  • Petz Aladar Megyei Oktato Korhaz ( Site 0213)

    Győr, Győr-Moson-Sopron, 9024

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

    Gyula, Bekes County, 5700

  • Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 0217)

    Kaposvár, 7400

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

    Miskolc, Borsod-Abauj Zemplen county, 3529

  • CRU Hungary KFT ( Site 0209)

    Miskolc, Borsod-Abauj Zemplen county, 3529

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

    Szolnok, Jász-Nagykun-Szolnok, 5000

  • Tudogyogyintezet Torokbalint ( Site 0205)

    Törökbálint, Pest County, 2045

Other trials in Hungary

Israel8 sites

  • Barzilai Medical Center ( Site 0226)

    Ashkelon, Ḥeifā, 7830604

  • Soroka Medical Center ( Site 0222)

    Beersheba, 8457108

  • Bnei Zion Medical Center ( Site 0227)

    Haifa, Heifa, 3339419

  • Rambam Medical Center ( Site 0223)

    Haifa, 3109601

  • Meir Medical Center ( Site 0221)

    Kfar Saba, 4428132

  • Rabin Medical Center ( Site 0224)

    Petah Tikva, 4941492

  • Sheba Medical Center ( Site 0220)

    Ramat Gan, Tel Aviv, 5266202

  • Sourasky Medical Center ( Site 0225)

    Tel Aviv, 6423906

Other trials in Israel

Italy8 sites

  • Azienda Ospedaliera San Giuseppe Moscati ( Site 0234)

    Avellino, 83100

  • Centro di Riferimento Oncologico CRO ( Site 0235)

    Aviano, Pordenone, 33081

  • Universita Magna Grecia ( Site 0230)

    Catanzaro, 88100

  • A.O. Universitaria Careggi ( Site 0236)

    Florence, 50134

  • Ospedale Santa Maria delle Croci ( Site 0232)

    Ravenna, 48121

  • Policlinico Gemelli di Roma ( Site 0237)

    Roma, 00168

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

    Rome, Lazio, 00185

  • Presidio Ospedaliero San Vincenzo ( Site 0231)

    Taormina, Messina, 98039

Other trials in Italy

Poland8 sites

  • Krakowski Szpital Specjalistyczny im Jana Pawla II ( Site 0253)

    Krakow, Lesser Poland Voivodeship, 31-202

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

    Krakow, Lesser Poland Voivodeship, 31-826

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

    Lodz, Łódź Voivodeship, 99-153

  • Centrum Medyczne Pratia Ostroleka ( Site 0242)

    Ostrołęka, Masovian Voivodeship, 07-410

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

    Piła, Greater Poland Voivodeship, 64-920

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

    Przemyśl, Podkarpackie Voivodeship, 37-700

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

    Warsaw, Masovian Voivodeship, 02-781

  • Szpital Uniwersytecki im. Karola Marcinkowskiego ( Site 0247)

    Zielona Góra, Lubusz Voivodeship, 65-046

Other trials in Poland

Malaysia7 sites

  • Hospital Pulau Pinang. ( Site 0065)

    George Town, Pulau Pinang, 10990

  • University Malaya Medical Centre ( Site 0061)

    Kuala Lumpur, 59100

  • Hospital Tengku Ampuan Afzan ( Site 0062)

    Kuantan, Pahang, 25100

  • Sarawak General Hospital ( Site 0064)

    Kuching, Sarawak, 93586

  • Beacon Hospital Sdn Bhd ( Site 0067)

    Petaling Jaya, Selangor, 46050

  • Gleneagles Penang ( Site 0066)

    Pulau Pinang, 10050

  • Institut Kanser Negara - National Cancer Institute ( Site 0063)

    Putrajaya, Putrajaya, 62250

Other trials in Malaysia

Russia7 sites

  • Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 0269)

    Kazan', Tatarstan, Respublika, 420029

  • Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0266)

    Krasnoyarsk, Krasnoyarsk Krai, 660133

  • SBHI Leningrad Regional Clinical Hospital ( Site 0263)

    Saint Petersburg, Sankt-Peterburg, 194291

  • Railway Hospital of OJSC ( Site 0268)

    Saint Petersburg, Sankt-Peterburg, 195271

  • City Clinical Oncology Center ( Site 0260)

    Saint Petersburg, Sankt-Peterburg, 198255

  • SBHI Samara Regional Clinical Oncology Dispensary ( Site 0265)

    Samara, Samara Oblast, 443031

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

    Ufa, Baskortostan, Respublika, 450054

Other trials in Russia

Colombia6 sites

  • Biomelab S A S ( Site 0365)

    Barranquilla, Atlántico, 080002

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

    Cali, Valle del Cauca Department, 760023

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

    Medellín, Antioquia, 050015

  • Fundacion Centro de Investigacion Clinica CIC ( Site 0366)

    Medellín, Antioquia, 050021

  • Oncomedica S.A. ( Site 0372)

    Montería, Departamento de Córdoba, 230002

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

    Valledupar, Cesar Department, 200001

Other trials in Colombia

Taiwan6 sites

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

    Hsinchu, 300

  • Taipei Medical University Shuang Ho Hospital ( Site 0090)

    New Taipei City, 235

  • National Cheng Kung University Hospital ( Site 0086)

    Tainan, 70457

  • National Taiwan University Hospital ( Site 0088)

    Taipei, 10002

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

    Taipei, 112

  • Taipei Veterans General Hospital ( Site 0089)

    Taipei, 112

Other trials in Taiwan

Australia5 sites

  • The Prince Charles Hospital ( Site 0011)

    Chermside, Queensland, 4032

  • Orange Health Services ( Site 0002)

    Orange, New South Wales, 2800

  • St John of God Murdoch Medical Clinic ( Site 0001)

    Perth, Western Australia, 6150

  • Ballarat Oncology and Haematology Services ( Site 0008)

    Wendouree, Victoria, 3355

  • Wollongong Private Hospital ( Site 0005)

    Wollongong, New South Wales, 2500

Other trials in Australia

Canada5 sites

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

    Brampton, Ontario, L6R 3J7

  • Cross Cancer Institute ( Site 0400)

    Edmonton, Alberta, T6G 1Z2

  • McGill University Health Centre ( Site 0418)

    Montreal, Quebec, H4A 3J1

  • Lions Gate Hospital ( Site 0407)

    North Vancouver, British Columbia, V7L 2L7

  • Windsor Regional Cancer Program ( Site 0404)

    Windsor, Ontario, N8W 2X3

Other trials in Canada

Mexico5 sites

  • Consultorios de Medicina Especializada del Sector Privado ( Site 0388)

    Guadalajara, Jalisco, 44680

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

    Madero, Tamaulipas, 89440

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

    Mexico City, Mexico City, 14050

  • Instituto Nacional de Cancerologia. ( Site 0382)

    Mexico City, 14080

  • Oaxaca Site Management Organization SC ( Site 0389)

    Oaxaca City, 68000

Other trials in Mexico

South Korea5 sites

  • Chungbuk National University Hospital ( Site 0079)

    Cheongju-si, North Chungcheong, 28644

  • Seoul National University Bundang Hospital ( Site 0075)

    Seongnam-si, Kyonggi-do, 13620

  • Asan Medical Center ( Site 0076)

    Seoul, 05505

  • SMG-SNU Boramae Medical Center ( Site 0078)

    Seoul, 07061

  • Ulsan University Hospital ( Site 0077)

    Ulsan, Ulsan-Kwangyokshi, 44033

Other trials in South Korea

Estonia3 sites

  • AS Ida-Tallinna Keskhaigla ( Site 0161)

    Tallinn, Harju, 11312

  • SA Pohja-Eesti Regionaalhaigla ( Site 0162)

    Tallinn, Harju, 13419

  • SA Tartu Ulikooli Kliinikum ( Site 0160)

    Tartu, Tartu, 50406

Other trials in Estonia

About this study

Official title: A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) in Participants With Treatment-naïve, Metastatic Nonsmall Cell Lung Cancer (NSCLC) Whose Tumors Have a Tumor Proportion Score (TPS) Greater Than or Equal to 1% (LEAP-007)

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).

Read the detailed 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.

Being tested
Pembrolizumab, Lenvatinib, Placebo for lenvatinib
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

  • LenvatinibDrug

    Also called MK-7902, E7080, LENVIMA®

    oral capsule

  • Placebo for lenvatinibDrug

    oral capsule

Study groups in NCT03829332
Study groupRoleWhat they receive
Pembrolizumab + LenvatinibExperimentalParticipants 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.
Receives: Biological: Pembrolizumab; Drug: Lenvatinib
Pembrolizumab + PlaceboActive comparatorParticipants 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.
Receives: Biological: Pembrolizumab; Drug: Placebo for lenvatinib

What is being measured

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

  1. 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.

    Measured: Up to approximately 25 months

  2. Overall Survival (OS)

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

    Measured: Up to approximately 25 months

Secondary outcomes (14)

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

    ORR was defined as the percentage of participants in the analysis population 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) per RECIST 1.1. ORR as assessed by BICR per RECIST 1.1 is presented.

    Measured: Up to approximately 25 months

  2. Number of Participants Who Experienced an Adverse Event (AE)

    An AE was any untoward medical occurrence in a participant, 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 were reported

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

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

    An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinued study treatment due to an AE were reported.

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

  4. 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

    EORTC QLQ-C30 is a questionnaire to assess the overall quality of life (QoL) of cancer patients. Participant responses to questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) is computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. Per protocol, the change from baseline in GHS and QoL combined score was presented.

    Measured: Baseline and Week 21

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

    The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. Per protocol, the change from baseline in cough (EORTC QLQ-LC13 Item 31) score was presented.

    Measured: Baseline and Week 21

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

    The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. Per protocol, the change from baseline in EORTC QLQ-LC13 chest pain (Item 40) score was presented.

    Measured: Baseline and Week 21

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

    EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to the question: "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 dyspnea (Item 8) score was presented.

    Measured: Baseline and Week 21

  8. Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Score

    EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score was presented.

    Measured: Baseline and Week 21

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

    EORTC QLQ-C30 is a questionnaire to assess QoL of cancer patients. Participant responses to questions on GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall QoL during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) was computed by averaging raw scores of the 2 items and applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. TTD was defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in GHS-QoL combined score. A longer TTD indicates a better outcome.

    Measured: Up to approximately 25 months

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

    EORTC QLQ-LC13 is a lung cancer specific questionnaire. Participant responses to the question: "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0-100. A lower score indicates a better outcome. TTD was defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in cough (Item 31). A longer TTD indicates a better outcome.

    Measured: Up to approximately 25 months

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

    EORTC QLQ-LC13 is a lung cancer specific questionnaire. Participant responses to the question: "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0-100. A lower score indicates a better outcome. TTD was defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in cough (Item 40). A longer TTD indicates a better outcome.

    Measured: Up to approximately 25 months

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

    EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to the question: "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD was defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in dyspnea (Item 8). A longer TTD indicates a better outcome.

    Measured: Up to approximately 25 months

  13. Time to True Deterioration (TTD) Based on Change From Baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Score

    EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. TTD was defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in physical functioning (Items 1 to 5). A longer TTD indicates a better outcome.

    Measured: Up to approximately 25 months

  14. Time to True Deterioration (TTD) Based on Change From Baseline in the Composite Endpoint of Cough (EORTC QLQ-LC13 Item 31), Chest Pain (EORTC QLQ-LC13 Item 40), or Dyspnea (EORTC QLQ-C30 Item 8)

    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; score range:1=Not at All to 4=Very Much). 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; score range:1=Not at All to 4=Very Much ) and chest pain (Item 40, score range: 1=Not at All to 4=Very Much). The combined score of items 31, 40 and 8 was computed by averaging the raw scores of the items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. The TTD in the composite endpoint of EORTC QLQ-LC13 Item 31, EORTC QLQ-LC13 Item 40, EORTC QLQ-C30 Item 8 scale score was presented, defined as the time to first onset of a ≥10point decrease from baseline in anyone of the three scale items. A longer TTD indicates better outcome.

    Measured: Up to approximately 25 months

Timeline

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

  1. First posted4 Feb 2019
  2. Study start13 Mar 2019
  3. Primary completion19 May 2021
  4. Study completion24 Apr 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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
623 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03829332
Sponsor's protocol ID
7902-007
Other IDs
MK-7902-007, E7080-G000-314, LEAP-007, 194670, 2018-003794-98, 2018
Status last verified
Feb 2026
First submitted
1 Feb 2019
Last updated
19 Feb 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

  • 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.

    PubMed 38159809

  • 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 and Lenvatinib in people with Non-small Cell Lung Cancer, run by Merck Sharp & Dohme LLC at 162 sites in 19 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 10 inclusion and 23 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 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 162 sites in United States, China, Japan, Ukraine, France and 14 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 2 Jun 2022). 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?

Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) (time frame: Up to approximately 25 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 NCT03829332, which also lists 2 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 19 Feb 2026.

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