Clinical trial NCT03829332: 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)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Eisai Inc.
First posted: 2019-02-04
Enrollment: 623
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: Inclusion Criteria:

* 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

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

Primary outcomes:
measure: Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
timeFrame: Up to approximately 25 months
measure: Overall Survival (OS)
timeFrame: Up to approximately 25 months
Secondary outcomes:
measure: Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
timeFrame: Up to approximately 25 months
measure: Number of Participants Who Experienced an Adverse Event (AE)
timeFrame: Through 90 days post last dose of study treatment (Up to approximately 27 months)
measure: Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
timeFrame: Through last dose of study treatment (Up to approximately 24 months)
measure: 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
timeFrame: Baseline and Week 21
measure: Change From Baseline in Cough (EORTC Quality of Life Questionnaire-Lung Cancer Module 13 [QLQ-LC13] Item 31) Score
timeFrame: Baseline and Week 21
measure: Change From Baseline in Chest Pain (EORTC QLQ-LC13 Item 40) Score
timeFrame: Baseline and Week 21
measure: Change From Baseline in Dyspnea (EORTC QLQ-C30 Item 8) Score
timeFrame: Baseline and Week 21
measure: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Score
timeFrame: Baseline and Week 21
measure: Time to True Deterioration (TTD) in EORTC QLQ-C30 Combined Global Health Status /Quality of Life (Items 29 & 30) Scale Combined Score
timeFrame: Up to approximately 25 months
measure: Time to True Deterioration (TTD) in EORTC QLQ-LC13 Cough (Item 31) Scale Score
timeFrame: Up to approximately 25 months
measure: Time to True Deterioration (TTD) in EORTC QLQ-LC13 Chest Pain (Item 40) Scale Score
timeFrame: Up to approximately 25 months
measure: Time to True Deterioration (TTD) in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score
timeFrame: Up to approximately 25 months
measure: Time to True Deterioration (TTD) Based on Change From Baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Score
timeFrame: Up to approximately 25 months
measure: 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)
timeFrame: Up to approximately 25 months
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Clinical Research Center ( Site 0511)
state: Alaska
city: Chandler
country: United States
facility: Ironwood Cancer & Research Centers ( Site 0541)
state: Arizona
city: Bakersfield
country: United States
facility: CBCC Global Research, Inc. ( Site 0532)
state: California
city: La Jolla
country: United States
facility: Scripps Cancer Center ( Site 0521)
state: California
city: Orlando
country: United States
facility: Florida Hospital ( Site 0526)
state: Florida
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers PC ( Site 0518)
state: Georgia
city: Peoria
country: United States
facility: Illinois Cancer Care, PC ( Site 0557)
state: Illinois
city: Fort Wayne
country: United States
facility: Parkview Cancer Center ( Site 0542)
state: Indiana
city: Lexington
country: United States
facility: University of Kentucky School of Medicine & Hospitals ( Site 0517)
state: Kentucky
city: Annapolis
country: United States
facility: Anne Arundel Medical Center Oncology and Hematology ( Site 0514)
state: Maryland
city: Traverse City
country: United States
facility: Munson Medical Center ( Site 0512)
state: Michigan
city: Saint Louis Park
country: United States
facility: Park Nicollet Frauenshuh Cancer Center ( Site 0554)
state: Minnesota
city: Columbia
country: United States
facility: University of Missouri Health Care ( Site 0555)
state: Missouri
city: Billings
country: United States
facility: Billings Clinic Cancer Center ( Site 0508)
state: Montana
city: Greensboro
country: United States
facility: Cone Health Cancer Center at Alamance Regional ( Site 0527)
state: North Carolina
city: Zanesville
country: United States
facility: Genesis Cancer Care Center ( Site 0559)
state: Ohio
city: Portland
country: United States
facility: Oregon Health Sciences University ( Site 0544)
state: Oregon
city: Temple
country: United States
facility: Central Texas Veterans Healthcare System ( Site 0533)
state: Texas
city: Orange
country: Australia
facility: Orange Health Services ( Site 0002)
state: New South Wales
city: Wollongong
country: Australia
facility: Wollongong Private Hospital ( Site 0005)
state: New South Wales
city: Chermside
country: Australia
facility: The Prince Charles Hospital ( Site 0011)
state: Queensland
city: Wendouree
country: Australia
facility: Ballarat Oncology and Haematology Services ( Site 0008)
state: Victoria
city: Perth
country: Australia
facility: St John of God Murdoch Medical Clinic ( Site 0001)
state: Western Australia
city: Edmonton
country: Canada
facility: Cross Cancer Institute ( Site 0400)
state: Alberta
city: North Vancouver
country: Canada
facility: Lions Gate Hospital ( Site 0407)
state: British Columbia
city: Brampton
country: Canada
facility: William Osler Health System (Brampton Civic Hospital) ( Site 0402)
state: Ontario
city: Windsor
country: Canada
facility: Windsor Regional Cancer Program ( Site 0404)
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre ( Site 0418)
state: Quebec
city: Beijing
country: China
facility: Beijing Chest Hospital Capital Medical University ( Site 0111)
state: Anhui
city: Hefei
country: China
facility: Anhui Provincial Hospital ( Site 0108)
state: Anhui
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University ( Site 0113)
state: Anhui
city: Beijing
country: China
facility: Peking Union Medical College Hospital ( Site 0105)
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital ( Site 0102)
state: Beijing
city: Changsha
country: China
facility: Xiangya Hospital of Central South University ( Site 0115)
state: Hunan
city: Changsha
country: China
facility: Hunan Cancer Hospital ( Site 0104)
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital ( Site 0101)
state: Jiangsu
city: Chang chun
country: China
facility: The First Hospital of Jilin University ( Site 0110)
state: Jilin
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University ( Site 0100)
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Chest Hospital ( Site 0112)
state: Shanghai
city: XiAn
country: China
facility: 1st Affil Hosp of Med College of Xi'an Jiaotong University ( Site 0103)
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital of Sichuan University ( Site 0117)
state: Sichuan
city: Hangzhou
country: China
facility: The First Affiliated Hospital Zhejiang University ( Site 0106)
state: Zhejiang
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital ( Site 0109)
state: Zhejiang
city: Hangzhou
country: China
facility: 2nd Affil Hosp of Zhejiang University College of Medicine ( Site 0114)
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital ( Site 0116)
state: Zhejiang
city: Medellin
country: Colombia
facility: Hospital General de Medellin Luz Castro de Gutierrez ( Site 0368)
state: Antioquia
city: Medellin
country: Colombia
facility: Fundacion Centro de Investigacion Clinica CIC ( Site 0366)
state: Antioquia
city: Barranquilla
country: Colombia
facility: Biomelab S A S ( Site 0365)
state: Atlantico
city: Valledupar
country: Colombia
facility: Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0374)
state: Cesar
city: Monteria
country: Colombia
facility: Oncomedica S.A. ( Site 0372)
state: Cordoba
city: Cali
country: Colombia
facility: Centro Medico Imbanaco de Cali S.A ( Site 0369)
state: Valle Del Cauca
city: Tallinn
country: Estonia
facility: AS Ida-Tallinna Keskhaigla ( Site 0161)
state: Harjumaa
city: Tallin
country: Estonia
facility: SA Pohja-Eesti Regionaalhaigla ( Site 0162)
state: Harjumaa
city: Tartu
country: Estonia
facility: SA Tartu Ulikooli Kliinikum ( Site 0160)
state: Tartumaa
city: Besancon
country: France
facility: CHU Jean Minjoz ( Site 0167)
state: Doubs
city: Saint-Cloud
country: France
facility: Institut Curie - Centre Rene Huguenin ( Site 0181)
state: Hauts-de-Seine
city: Montpellier
country: France
facility: ICM Val D Auerelle ( Site 0177)
state: Herault
city: La Tronche
country: France
facility: CHU de Grenoble - Hopital Michallon ( Site 0169)
state: Isere
city: Saint Herblain
country: France
facility: Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0185)
state: Loire-Atlantique
city: Bayonne
country: France
facility: Centre Hospitalier de la Cote Basque ( Site 0173)
state: Pyrenees-Atlantiques
city: Rouen
country: France
facility: CHU de Rouen ( Site 0174)
state: Seine-Maritime
city: Amiens
country: France
facility: CHU Amiens Sud ( Site 0182)
state: Somme
city: Toulon
country: France
facility: Centre hospitalier Toulon Sainte-Musse ( Site 0172)
state: Var
city: Paris
country: France
facility: Institut Curie ( Site 0166)
city: Gyula
country: Hungary
facility: Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 0207)
state: Bekes
city: Miskolc
country: Hungary
facility: Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz ( Site 0202)
state: Borsod-Abauj-Zemplen
city: Miskolc
country: Hungary
facility: CRU Hungary KFT ( Site 0209)
state: Borsod-Abauj-Zemplen
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Oktato Korhaz ( Site 0213)
state: Gyor-Moson-Sopron
city: Szolnok
country: Hungary
facility: Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0203)
state: Jasz-Nagykun-Szolnok
city: Torokbalint
country: Hungary
facility: Tudogyogyintezet Torokbalint ( Site 0205)
state: Pest
city: Budapest
country: Hungary
facility: Semmelweis Egyetem ( Site 0210)
city: Kaposvar
country: Hungary
facility: Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 0217)
city: Haifa
country: Israel
facility: Bnei Zion Medical Center ( Site 0227)
state: Heifa
city: Ramat Gan
country: Israel
facility: Sheba Medical Center ( Site 0220)
state: Tel Aviv
city: Beer Sheva
country: Israel
facility: Soroka Medical Center ( Site 0222)
city: Haifa
country: Israel
facility: Rambam Medical Center ( Site 0223)
city: Kfar-Saba
country: Israel
facility: Meir Medical Center ( Site 0221)
city: Petah Tikva
country: Israel
facility: Rabin Medical Center ( Site 0224)
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center ( Site 0225)
city: Ashkelon
country: Israel
facility: Barzilai Medical Center ( Site 0226)
state: Ḥeifā
city: Roma
country: Italy
facility: Azienda Ospedaliera S. Giovanni Addolorata-Oncologia Medica ( Site 0233)
state: Lazio
city: Taormina
country: Italy
facility: Presidio Ospedaliero San Vincenzo ( Site 0231)
state: Messina
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico CRO ( Site 0235)
state: Pordenone
city: Avellino
country: Italy
facility: Azienda Ospedaliera San Giuseppe Moscati ( Site 0234)
city: Catanzaro
country: Italy
facility: Universita Magna Grecia ( Site 0230)
city: Firenze
country: Italy
facility: A.O. Universitaria Careggi ( Site 0236)
city: Ravenna
country: Italy
facility: Ospedale Santa Maria delle Croci ( Site 0232)
city: Roma
country: Italy
facility: Policlinico Gemelli di Roma ( Site 0237)
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital ( Site 0018)
state: Aichi
city: Kurume
country: Japan
facility: Kurume University Hospital ( Site 0025)
state: Fukuoka
city: Akashi
country: Japan
facility: Hyogo Cancer Center ( Site 0021)
state: Hyogo
city: Yokohama
country: Japan
facility: Kanagawa Cardiovascular and Respiratory Center ( Site 0026)
state: Kanagawa
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center ( Site 0023)
state: Kanagawa
city: Natori
country: Japan
facility: Miyagi Cancer Center ( Site 0028)
state: Miyagi
city: Sendai
country: Japan
facility: Sendai Kousei Hospital ( Site 0022)
state: Miyagi
city: Osakasayama
country: Japan
facility: Kindai University Hospital ( Site 0017)
state: Osaka
city: Sakai
country: Japan
facility: National Hospital Organization Kinki-chuo Chest Medical Center ( Site 0027)
state: Osaka
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center ( Site 0015)
city: Fukuoka
country: Japan
facility: Kyushu University Hospital ( Site 0030)
city: Okayama
country: Japan
facility: Okayama University Hospital ( Site 0020)
city: Osaka
country: Japan
facility: Osaka International Cancer Institute ( Site 0019)
city: Tokyo
country: Japan
facility: Toranomon Hospital ( Site 0016)
city: Tokyo
country: Japan
facility: Juntendo University Hospital ( Site 0029)
city: Tokyo
country: Japan
facility: Nippon Medical School Hospital ( Site 0024)
city: Cheongju si
country: Korea, Republic of
facility: Chungbuk National University Hospital ( Site 0079)
state: Chungbuk
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital ( Site 0075)
state: Kyonggi-do
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital ( Site 0077)
state: Ulsan-Kwangyokshi
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center ( Site 0076)
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center ( Site 0078)
city: Kuantan
country: Malaysia
facility: Hospital Tengku Ampuan Afzan ( Site 0062)
state: Pahang
city: Georgetown
country: Malaysia
facility: Hospital Pulau Pinang. ( Site 0065)
state: Pulau Pinang
city: Kuching
country: Malaysia
facility: Sarawak General Hospital ( Site 0064)
state: Sarawak
city: Petaling Jaya
country: Malaysia
facility: Beacon Hospital Sdn Bhd ( Site 0067)
state: Selangor
city: Putrajaya
country: Malaysia
facility: Institut Kanser Negara - National Cancer Institute ( Site 0063)
state: Wilayah Persekutuan Putrajaya
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre ( Site 0061)
city: Pulau Pinang
country: Malaysia
facility: Gleneagles Penang ( Site 0066)
city: Mexico City
country: Mexico
facility: Medica Sur S.A.B de C.V. ( Site 0384)
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Consultorios de Medicina Especializada del Sector Privado ( Site 0388)
state: Jalisco
city: Madero
country: Mexico
facility: Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 0381)
state: Tamaulipas
city: Mexico City
country: Mexico
facility: Instituto Nacional de Cancerologia. ( Site 0382)
city: Oaxaca
country: Mexico
facility: Oaxaca Site Management Organization SC ( Site 0389)
city: Lodz
country: Poland
facility: SPZOZ USK nr 1 im. Norberta Barlickiego UM w Lodzi ( Site 0256)
state: Lodzkie
city: Zielona Gora
country: Poland
facility: Szpital Uniwersytecki im. Karola Marcinkowskiego ( Site 0247)
state: Lubuskie
city: Krakow
country: Poland
facility: Krakowski Szpital Specjalistyczny im Jana Pawla II ( Site 0253)
state: Malopolskie
city: Krakow
country: Poland
facility: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 0243)
state: Malopolskie
city: Ostroleka
country: Poland
facility: Centrum Medyczne Pratia Ostroleka ( Site 0242)
state: Mazowieckie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0252)
state: Mazowieckie
city: Przemysl
country: Poland
facility: Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 0250)
state: Podkarpackie
city: Pila
country: Poland
facility: Ars Medical Sp. z o.o. ( Site 0254)
state: Wielkopolskie
city: Ufa
country: Russian Federation
facility: Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 0262)
state: Baskortostan, Respublika
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0266)
state: Krasnoyarskiy Kray
city: Samara
country: Russian Federation
facility: SBHI Samara Regional Clinical Oncology Dispensary ( Site 0265)
state: Samarskaya Oblast
city: Saint Petersburg
country: Russian Federation
facility: SBHI Leningrad Regional Clinical Hospital ( Site 0263)
state: Sankt-Peterburg
city: Saint Petersburg
country: Russian Federation
facility: Railway Hospital of OJSC ( Site 0268)
state: Sankt-Peterburg
city: Saint Petersburg
country: Russian Federation
facility: City Clinical Oncology Center ( Site 0260)
state: Sankt-Peterburg
city: Kazan
country: Russian Federation
facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 0269)
state: Tatarstan, Respublika
city: Hsinchu
country: Taiwan
facility: National Taiwan University Hospital Hsin-Chu Branch ( Site 0087)
city: New Taipei
country: Taiwan
facility: Taipei Medical University Shuang Ho Hospital ( Site 0090)
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital ( Site 0086)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital ( Site 0088)
city: Taipei
country: Taiwan
facility: Koo Foundation Sun Yat-Sen Cancer Center ( Site 0091)
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital ( Site 0089)
city: Konya
country: Turkey
facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 0321)
state: Adana
city: Ankara
country: Turkey
facility: Gulhane Egitim ve Arastirma Hastanesi ( Site 0316)
city: Ankara
country: Turkey
facility: Abdurrahman Yurtaslan Onkoloji Hastanesi ( Site 0318)
city: Ankara
country: Turkey
facility: Baskent Universitesi Ankara Hastanesi ( Site 0319)
city: Antalya
country: Turkey
facility: Antalya Memorial Hospital Department of Medical Oncology ( Site 0324)
city: Antalya
country: Turkey
facility: Akdeniz Universitesi Tip Fakultesi ( Site 0322)
city: Izmir
country: Turkey
facility: Dokuz Eylul Universitesi Arastirma Uygulama Hastanesi ( Site 0314)
city: Sakarya
country: Turkey
facility: Sakarya Universitesi Egitim ve Arastirma Hastanesi ( Site 0323)
city: Samsun
country: Turkey
facility: Samsun Medical Park Hastanesi ( Site 0320)
city: Cherkasy
country: Ukraine
facility: Cherkasy Regional Hospital ( Site 0336)
state: Cherkaska Oblast
city: Dnipro
country: Ukraine
facility: City Clinical Hosp.4 of DCC ( Site 0338)
state: Dnipropetrovska Oblast
city: Ivano-Frankivsk
country: Ukraine
facility: MI Precarpathian Clinical Oncology Center ( Site 0346)
state: Ivano-Frankivska Oblast
city: Kharkiv
country: Ukraine
facility: Regional Centre of Oncology-Thoracic organs ( Site 0337)
state: Kharkivska Oblast
city: Kropyvnytskiy
country: Ukraine
facility: Ukranian Center of TomoTherapy ( Site 0344)
state: Kirovohradska Oblast
city: Kyiv
country: Ukraine
facility: Medical Center Verum ( Site 0334)
state: Kyivska Oblast
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Oncology Centre ( Site 0339)
state: Kyivska Oblast
city: Kyiv
country: Ukraine
facility: Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 0331)
state: Kyivska Oblast
city: Lviv
country: Ukraine
facility: Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 0341)
state: Lvivska Oblast
city: Odesa
country: Ukraine
facility: MI Odessa Regional Oncological Centre ( Site 0333)
state: Odeska Oblast
city: Vinnytsia
country: Ukraine
facility: Podillya Regional Center of Oncology ( Site 0343)
state: Vinnytska Oblast
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.