KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A)
Start Date
12/19/2019
Completion Date
10/13/2032
Summary
The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) with or without chemotherapy in combination with vibostolimab (MK-7684), boserolimab (MK-5890), MK-4830, MK-0482, I-DXd, or HER3-DXd in treatment-naïve participants with advanced squamous or non-squamous NSCLC. This study is one of the pembrolizumab substudies being conducted under one pembrolizumab umbrella master protocol (MK-3475-U01/KEYMAKER-U01).
Detailed Description
The master screening protocol is MK-3475-U01 (KEYMAKER-U01) - NCT04165798
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Pembrolizumab
Carboplatin
Paclitaxel
Pemetrexed
Vibostolimab
Boserolimab
MK-4830
MK-0482
Ifinatamab Deruxtecan (I-DXd)
HER3-DXd
Conditions
Locations
Banner MD Anderson Cancer Center ( Site 0001)
Gilbert, Arizona 85234
United States
City of Hope ( Site 0014)
Duarte, California 91010
United States
UCSF Medical Center at Mission Bay ( Site 0007)
San Francisco, California 94158
United States
Georgetown University ( Site 0036)
Washington D.C., District of Columbia 20007
United States
University of Kentucky Markey Cancer Center ( Site 0019)
Lexington, Kentucky 40536-0293
United States
MedStar Franklin Square Medical Center ( Site 0033)
Baltimore, Maryland 21237
United States
Massachusetts General Hospital ( Site 0003)
Boston, Massachusetts 02114
United States
Dana Farber Cancer Institute ( Site 0002)
Boston, Massachusetts 02215
United States
Oncology Hematology West, PC DBA Nebraska Cancer Specialists ( Site 0031)
Omaha, Nebraska 68130
United States
Dartmouth Hitchcock Medical Center ( Site 0016)
Lebanon, New Hampshire 03766
United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0037)
Hackensack, New Jersey 07601
United States
Laura and Isaac Perlmutter Cancer Center ( Site 0034)
New York, New York 10016
United States
Sanford Fargo Medical Center ( Site 0039)
Fargo, North Dakota 58102
United States
Cleveland Clinic Main ( Site 0006)
Cleveland, Ohio 44195
United States
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0015)
Columbus, Ohio 43210
United States
Abramson Cancer Center of the University of Pennsylvania ( Site 0010)
Philadelphia, Pennsylvania 19104
United States
Sanford Cancer Center ( Site 0038)
Sioux Falls, South Dakota 57104
United States
The University of Texas MD Anderson Cancer Center ( Site 0009)
Houston, Texas 77030
United States
Petz Aladar Megyei Oktato Korhaz ( Site 0062)
Győr, Győr-Moson-Sopron 9024
Hungary
Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 0061)
Szolnok, Jász-Nagykun-Szolnok 5004
Hungary
Orszagos Koranyi Pulmonologiai Intezet ( Site 0060)
Budapest, 1121
Hungary
Soroka Medical Center ( Site 0072)
Beersheba, 8457108
Israel
Rambam Health Care Campus-Oncology ( Site 0076)
Haifa, 3109601
Israel
Shaare Zedek Medical Center ( Site 0075)
Jerusalem, 9103102
Israel
Meir Medical Center ( Site 0071)
Kfar Saba, 4428132
Israel
Rabin Medical Center ( Site 0074)
Petah Tikva, 4941492
Israel
Chaim Sheba Medical Center ( Site 0070)
Ramat Gan, 5262000
Israel
Sourasky Medical Center ( Site 0077)
Tel Aviv, 6423906
Israel
Azienda Ospedaliera Universitaria Careggi ( Site 0173)
Florence, Firenze 50134
Italy
IRCCS Ospedale San Raffaele ( Site 0171)
Milan, 20132
Italy
Policlinico Gemelli di Roma ( Site 0174)
Roma, 00168
Italy
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 0151)
Warsaw, Masovian Voivodeship 02-781
Poland
Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150)
Gdansk, Pomeranian Voivodeship 80-952
Poland
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0152)
Koszalin, West Pomeranian Voivodeship 75-581
Poland
Seoul National University Bundang Hospital ( Site 0081)
Seongnam-si, Kyonggi-do 13620
South Korea
Severance Hospital ( Site 0080)
Seoul, 03722
South Korea
Samsung Medical Center ( Site 0082)
Seoul, 06351
South Korea
ICO L Hospitalet ( Site 0090)
L'Hospitalet de Llobregat, Barcelona 08907
Spain
Hospital Universitario Quiron Madrid ( Site 0091)
Madrid, 28223
Spain
Changhua Christian Hospital ( Site 0181)
Changhua, 50006
Taiwan
Taipei Medical University Hospital ( Site 0180)
Taipei, 110301
Taiwan
Chang Gung Medical Foundation-Linkou Branch ( Site 0182)
Taoyuan, 33305
Taiwan
COMMUNAL NONPROFIT ENTERPRISE CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 0463)
Cherkasy, Cherkasy Oblast 18009
Ukraine
Communal Non-Commercial Enterprise "Prykarpatski Clinical On-Surgery department #2 ( Site 0460)
Ivano-Frankivsk, Ivano-Frankivsk Oblast 76018
Ukraine
ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 0461)
Rivne, Rivne Oblast 33010
Ukraine
Uzhhorod Multispecialty City Clinical Hospital ( Site 0462)
Uzhhorod, Zakarpattia Oblast 88017
Ukraine