Spots Global Cancer Trial Database for 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)
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Trial Identification
Brief Title: 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 ID: NCT03829332
Conditions
Study Description
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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Alaska Clinical Research Center ( Site 0511), Anchorage, Alaska, United States
Ironwood Cancer & Research Centers ( Site 0541), Chandler, Arizona, United States
CBCC Global Research, Inc. ( Site 0532), Bakersfield, California, United States
Scripps Cancer Center ( Site 0521), La Jolla, California, United States
Florida Hospital ( Site 0526), Orlando, Florida, United States
Northwest Georgia Oncology Centers PC ( Site 0518), Marietta, Georgia, United States
Illinois Cancer Care, PC ( Site 0557), Peoria, Illinois, United States
Parkview Cancer Center ( Site 0542), Fort Wayne, Indiana, United States
University of Kentucky School of Medicine & Hospitals ( Site 0517), Lexington, Kentucky, United States
Anne Arundel Medical Center Oncology and Hematology ( Site 0514), Annapolis, Maryland, United States
Munson Medical Center ( Site 0512), Traverse City, Michigan, United States
Park Nicollet Frauenshuh Cancer Center ( Site 0554), Saint Louis Park, Minnesota, United States
University of Missouri Health Care ( Site 0555), Columbia, Missouri, United States
Billings Clinic Cancer Center ( Site 0508), Billings, Montana, United States
Cone Health Cancer Center at Alamance Regional ( Site 0527), Greensboro, North Carolina, United States
Genesis Cancer Care Center ( Site 0559), Zanesville, Ohio, United States
Oregon Health Sciences University ( Site 0544), Portland, Oregon, United States
Central Texas Veterans Healthcare System ( Site 0533), Temple, Texas, United States
Orange Health Services ( Site 0002), Orange, New South Wales, Australia
Wollongong Private Hospital ( Site 0005), Wollongong, New South Wales, Australia
The Prince Charles Hospital ( Site 0011), Chermside, Queensland, Australia
Ballarat Oncology and Haematology Services ( Site 0008), Wendouree, Victoria, Australia
St John of God Murdoch Medical Clinic ( Site 0001), Perth, Western Australia, Australia
Cross Cancer Institute ( Site 0400), Edmonton, Alberta, Canada
Lions Gate Hospital ( Site 0407), North Vancouver, British Columbia, Canada
William Osler Health System (Brampton Civic Hospital) ( Site 0402), Brampton, Ontario, Canada
Windsor Regional Cancer Program ( Site 0404), Windsor, Ontario, Canada
McGill University Health Centre ( Site 0418), Montreal, Quebec, Canada
Beijing Chest Hospital Capital Medical University ( Site 0111), Beijing, Anhui, China
Anhui Provincial Hospital ( Site 0108), Hefei, Anhui, China
The First Affiliated Hospital of Anhui Medical University ( Site 0113), Hefei, Anhui, China
Peking Union Medical College Hospital ( Site 0105), Beijing, Beijing, China
Beijing Cancer Hospital ( Site 0102), Beijing, Beijing, China
Xiangya Hospital of Central South University ( Site 0115), Changsha, Hunan, China
Hunan Cancer Hospital ( Site 0104), Changsha, Hunan, China
Jiangsu Cancer Hospital ( Site 0101), Nanjing, Jiangsu, China
The First Hospital of Jilin University ( Site 0110), Chang chun, Jilin, China
Zhongshan Hospital Fudan University ( Site 0100), Shanghai, Shanghai, China
Shanghai Chest Hospital ( Site 0112), Shanghai, Shanghai, China
1st Affil Hosp of Med College of Xi'an Jiaotong University ( Site 0103), XiAn, Shanxi, China
West China Hospital of Sichuan University ( Site 0117), Chengdu, Sichuan, China
The First Affiliated Hospital Zhejiang University ( Site 0106), Hangzhou, Zhejiang, China
Hangzhou First People's Hospital ( Site 0109), Hangzhou, Zhejiang, China
2nd Affil Hosp of Zhejiang University College of Medicine ( Site 0114), Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital ( Site 0116), Hangzhou, Zhejiang, China
Hospital General de Medellin Luz Castro de Gutierrez ( Site 0368), Medellin, Antioquia, Colombia
Fundacion Centro de Investigacion Clinica CIC ( Site 0366), Medellin, Antioquia, Colombia
Biomelab S A S ( Site 0365), Barranquilla, Atlantico, Colombia
Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0374), Valledupar, Cesar, Colombia
Oncomedica S.A. ( Site 0372), Monteria, Cordoba, Colombia
Centro Medico Imbanaco de Cali S.A ( Site 0369), Cali, Valle Del Cauca, Colombia
AS Ida-Tallinna Keskhaigla ( Site 0161), Tallinn, Harjumaa, Estonia
SA Pohja-Eesti Regionaalhaigla ( Site 0162), Tallin, Harjumaa, Estonia
SA Tartu Ulikooli Kliinikum ( Site 0160), Tartu, Tartumaa, Estonia
CHU Jean Minjoz ( Site 0167), Besancon, Doubs, France
Institut Curie - Centre Rene Huguenin ( Site 0181), Saint-Cloud, Hauts-de-Seine, France
ICM Val D Auerelle ( Site 0177), Montpellier, Herault, France
CHU de Grenoble - Hopital Michallon ( Site 0169), La Tronche, Isere, France
Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0185), Saint Herblain, Loire-Atlantique, France
Centre Hospitalier de la Cote Basque ( Site 0173), Bayonne, Pyrenees-Atlantiques, France
CHU de Rouen ( Site 0174), Rouen, Seine-Maritime, France
CHU Amiens Sud ( Site 0182), Amiens, Somme, France
Centre hospitalier Toulon Sainte-Musse ( Site 0172), Toulon, Var, France
Institut Curie ( Site 0166), Paris, , France
Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 0207), Gyula, Bekes, Hungary
Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz ( Site 0202), Miskolc, Borsod-Abauj-Zemplen, Hungary
CRU Hungary KFT ( Site 0209), Miskolc, Borsod-Abauj-Zemplen, Hungary
Petz Aladar Megyei Oktato Korhaz ( Site 0213), Gyor, Gyor-Moson-Sopron, Hungary
Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0203), Szolnok, Jasz-Nagykun-Szolnok, Hungary
Tudogyogyintezet Torokbalint ( Site 0205), Torokbalint, Pest, Hungary
Semmelweis Egyetem ( Site 0210), Budapest, , Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 0217), Kaposvar, , Hungary
Bnei Zion Medical Center ( Site 0227), Haifa, Heifa, Israel
Sheba Medical Center ( Site 0220), Ramat Gan, Tel Aviv, Israel
Soroka Medical Center ( Site 0222), Beer Sheva, , Israel
Rambam Medical Center ( Site 0223), Haifa, , Israel
Meir Medical Center ( Site 0221), Kfar-Saba, , Israel
Rabin Medical Center ( Site 0224), Petah Tikva, , Israel
Sourasky Medical Center ( Site 0225), Tel Aviv, , Israel
Barzilai Medical Center ( Site 0226), Ashkelon, Ḥeifā, Israel
Azienda Ospedaliera S. Giovanni Addolorata-Oncologia Medica ( Site 0233), Roma, Lazio, Italy
Presidio Ospedaliero San Vincenzo ( Site 0231), Taormina, Messina, Italy
Centro di Riferimento Oncologico CRO ( Site 0235), Aviano, Pordenone, Italy
Azienda Ospedaliera San Giuseppe Moscati ( Site 0234), Avellino, , Italy
Universita Magna Grecia ( Site 0230), Catanzaro, , Italy
A.O. Universitaria Careggi ( Site 0236), Firenze, , Italy
Ospedale Santa Maria delle Croci ( Site 0232), Ravenna, , Italy
Policlinico Gemelli di Roma ( Site 0237), Roma, , Italy
Aichi Cancer Center Hospital ( Site 0018), Nagoya, Aichi, Japan
Kurume University Hospital ( Site 0025), Kurume, Fukuoka, Japan
Hyogo Cancer Center ( Site 0021), Akashi, Hyogo, Japan
Kanagawa Cardiovascular and Respiratory Center ( Site 0026), Yokohama, Kanagawa, Japan
Kanagawa Cancer Center ( Site 0023), Yokohama, Kanagawa, Japan
Miyagi Cancer Center ( Site 0028), Natori, Miyagi, Japan
Sendai Kousei Hospital ( Site 0022), Sendai, Miyagi, Japan
Kindai University Hospital ( Site 0017), Osakasayama, Osaka, Japan
National Hospital Organization Kinki-chuo Chest Medical Center ( Site 0027), Sakai, Osaka, Japan
National Hospital Organization Kyushu Medical Center ( Site 0015), Fukuoka, , Japan
Kyushu University Hospital ( Site 0030), Fukuoka, , Japan
Okayama University Hospital ( Site 0020), Okayama, , Japan
Osaka International Cancer Institute ( Site 0019), Osaka, , Japan
Toranomon Hospital ( Site 0016), Tokyo, , Japan
Juntendo University Hospital ( Site 0029), Tokyo, , Japan
Nippon Medical School Hospital ( Site 0024), Tokyo, , Japan
Chungbuk National University Hospital ( Site 0079), Cheongju si, Chungbuk, Korea, Republic of
Seoul National University Bundang Hospital ( Site 0075), Seongnam-si, Kyonggi-do, Korea, Republic of
Ulsan University Hospital ( Site 0077), Ulsan, Ulsan-Kwangyokshi, Korea, Republic of
Asan Medical Center ( Site 0076), Seoul, , Korea, Republic of
SMG-SNU Boramae Medical Center ( Site 0078), Seoul, , Korea, Republic of
Hospital Tengku Ampuan Afzan ( Site 0062), Kuantan, Pahang, Malaysia
Hospital Pulau Pinang. ( Site 0065), Georgetown, Pulau Pinang, Malaysia
Sarawak General Hospital ( Site 0064), Kuching, Sarawak, Malaysia
Beacon Hospital Sdn Bhd ( Site 0067), Petaling Jaya, Selangor, Malaysia
Institut Kanser Negara - National Cancer Institute ( Site 0063), Putrajaya, Wilayah Persekutuan Putrajaya, Malaysia
University Malaya Medical Centre ( Site 0061), Kuala Lumpur, , Malaysia
Gleneagles Penang ( Site 0066), Pulau Pinang, , Malaysia
Medica Sur S.A.B de C.V. ( Site 0384), Mexico City, Distrito Federal, Mexico
Consultorios de Medicina Especializada del Sector Privado ( Site 0388), Guadalajara, Jalisco, Mexico
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 0381), Madero, Tamaulipas, Mexico
Instituto Nacional de Cancerologia. ( Site 0382), Mexico City, , Mexico
Oaxaca Site Management Organization SC ( Site 0389), Oaxaca, , Mexico
SPZOZ USK nr 1 im. Norberta Barlickiego UM w Lodzi ( Site 0256), Lodz, Lodzkie, Poland
Szpital Uniwersytecki im. Karola Marcinkowskiego ( Site 0247), Zielona Gora, Lubuskie, Poland
Krakowski Szpital Specjalistyczny im Jana Pawla II ( Site 0253), Krakow, Malopolskie, Poland
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 0243), Krakow, Malopolskie, Poland
Centrum Medyczne Pratia Ostroleka ( Site 0242), Ostroleka, Mazowieckie, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0252), Warszawa, Mazowieckie, Poland
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 0250), Przemysl, Podkarpackie, Poland
Ars Medical Sp. z o.o. ( Site 0254), Pila, Wielkopolskie, Poland
Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 0262), Ufa, Baskortostan, Respublika, Russian Federation
Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0266), Krasnoyarsk, Krasnoyarskiy Kray, Russian Federation
SBHI Samara Regional Clinical Oncology Dispensary ( Site 0265), Samara, Samarskaya Oblast, Russian Federation
SBHI Leningrad Regional Clinical Hospital ( Site 0263), Saint Petersburg, Sankt-Peterburg, Russian Federation
Railway Hospital of OJSC ( Site 0268), Saint Petersburg, Sankt-Peterburg, Russian Federation
City Clinical Oncology Center ( Site 0260), Saint Petersburg, Sankt-Peterburg, Russian Federation
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 0269), Kazan, Tatarstan, Respublika, Russian Federation
National Taiwan University Hospital Hsin-Chu Branch ( Site 0087), Hsinchu, , Taiwan
Taipei Medical University Shuang Ho Hospital ( Site 0090), New Taipei, , Taiwan
National Cheng Kung University Hospital ( Site 0086), Tainan, , Taiwan
National Taiwan University Hospital ( Site 0088), Taipei, , Taiwan
Koo Foundation Sun Yat-Sen Cancer Center ( Site 0091), Taipei, , Taiwan
Taipei Veterans General Hospital ( Site 0089), Taipei, , Taiwan
Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 0321), Konya, Adana, Turkey
Gulhane Egitim ve Arastirma Hastanesi ( Site 0316), Ankara, , Turkey
Abdurrahman Yurtaslan Onkoloji Hastanesi ( Site 0318), Ankara, , Turkey
Baskent Universitesi Ankara Hastanesi ( Site 0319), Ankara, , Turkey
Antalya Memorial Hospital Department of Medical Oncology ( Site 0324), Antalya, , Turkey
Akdeniz Universitesi Tip Fakultesi ( Site 0322), Antalya, , Turkey
Dokuz Eylul Universitesi Arastirma Uygulama Hastanesi ( Site 0314), Izmir, , Turkey
Sakarya Universitesi Egitim ve Arastirma Hastanesi ( Site 0323), Sakarya, , Turkey
Samsun Medical Park Hastanesi ( Site 0320), Samsun, , Turkey
Cherkasy Regional Hospital ( Site 0336), Cherkasy, Cherkaska Oblast, Ukraine
City Clinical Hosp.4 of DCC ( Site 0338), Dnipro, Dnipropetrovska Oblast, Ukraine
MI Precarpathian Clinical Oncology Center ( Site 0346), Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine
Regional Centre of Oncology-Thoracic organs ( Site 0337), Kharkiv, Kharkivska Oblast, Ukraine
Ukranian Center of TomoTherapy ( Site 0344), Kropyvnytskiy, Kirovohradska Oblast, Ukraine
Medical Center Verum ( Site 0334), Kyiv, Kyivska Oblast, Ukraine
Kyiv City Clinical Oncology Centre ( Site 0339), Kyiv, Kyivska Oblast, Ukraine
Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 0331), Kyiv, Kyivska Oblast, Ukraine
Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 0341), Lviv, Lvivska Oblast, Ukraine
MI Odessa Regional Oncological Centre ( Site 0333), Odesa, Odeska Oblast, Ukraine
Podillya Regional Center of Oncology ( Site 0343), Vinnytsia, Vinnytska Oblast, Ukraine
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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