Pembrolizumab (MK-3475) Plus Investigational Agents in Resectable Non-small Cell Lung Cancer (NSCLC) (MK-3475-01E/KEYMAKER-U01)
Start Date
3/20/2025
Completion Date
2/6/2032
Summary
The main goals are after treatment given before surgery, to measure the number of people who have no signs of cancer cells in tumors and lymph nodes removed during surgery; and to learn about whether the cancer gets smaller or goes away by measuring the number of people with a certain number of living cancer cells in the tumor removed during surgery.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Pembrolizumab (neoadjuvant)
Cisplatin
Gemcitabine
Pemetrexed
Sacituzumab tirumotecan
H1 receptor antagonist
H2 receptor antagonist
Acetaminophen (or equivalent)
Dexamethasone (or equivalent)
Carboplatin
Pembrolizumab (adjuvant)
Paclitaxel
Steroid mouthwash (dexamethasone or equivalent)
Conditions
Locations
Southern Cancer Center (SCC) ( Site 8004)
Daphne, Alabama 36526
United States
Sansum Clinic (Ridley Tree) ( Site 8012)
Santa Barbara, California 93105
United States
Rocky Mountain Cancer Centers (RMCC) ( Site 8011)
Lone Tree, Colorado 80124
United States
MedStar Franklin Square Medical Center ( Site 0033)
Baltimore, Maryland 21237
United States
Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8006)
Eugene, Oregon 97401
United States
Texas Oncology - Central/South Texas ( Site 8009)
Austin, Texas 78705
United States
Texas Oncology - Northeast Texas ( Site 8005)
Tyler, Texas 75702
United States
Virginia Cancer Specialists (VCS) ( Site 8002)
Fairfax, Virginia 22031
United States
Centro de Estudios Clínicos SAGA ( Site 0162)
Santiago, Region M. de Santiago 7500653
Chile
FALP ( Site 0161)
Santiago, Region M. de Santiago 7500921
Chile
Bradfordhill ( Site 0160)
Santiago, Region M. de Santiago 8420383
Chile
Alexandra General Hospital of Athens Oncology-Hematology Unit ( Site 0203)
Athens, Attica 115 28
Greece
ATTIKON GENERAL UNIVERSITY HOSPITAL-Oncology ( Site 0202)
Athens, Attica 12462
Greece
Metropolitan Hospital-4th Oncology Dept ( Site 0201)
Athens, Attica 185 47
Greece
University General Hospital of Heraklion ( Site 0200)
Heraklion, Irakleio 71110
Greece
Petz Aladar Egyetemi Oktato Korhaz-Pulmonológia (Dr. Szalai Zsuzsanna) ( Site 0062)
Győr, Győr-Moson-Sopron 9024
Hungary
Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 0061)
Szolnok, Jász-Nagykun-Szolnok 5000
Hungary
Országos Korányi Pulmonológiai Intézet ( Site 0060)
Budapest, 1121
Hungary
Azienda Ospedaliera Universitaria Careggi ( Site 0173)
Florence, Tuscany 50134
Italy
Ospedale San Raffaele. ( Site 0171)
Milan, 20132
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0175)
Milan, 20133
Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0174)
Roma, 00168
Italy
Wielkopolskie Centrum Pulmonologii i Torakochirurgii-Oddzial Onkologii Klinicznej z Pododdzialem Dz ( Site 0153)
Poznan, Greater Poland Voivodeship 60-569
Poland
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
Hospital Clinic de Barcelona ( Site 0092)
Barcelona, 08008
Spain
Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 0702)
Adana, 01250
Turkey (Türkiye)
Hacettepe Universite Hastaneleri-oncology hospital ( Site 0700)
Ankara, 06230
Turkey (Türkiye)
Akdeniz Universitesi Hastanesi-Medical Oncology ( Site 0704)
Antalya, 07059
Turkey (Türkiye)
İzmir Suat Seren Chest Disease Training & Research Hospital ( Site 0701)
Izmir, 35110
Turkey (Türkiye)
Ondokuz Mayıs Universitesi-Oncology department ( Site 0706)
Samsun, 55139
Turkey (Türkiye)
CNE CC of Oncology Hematol ( Site 0130)
Cherkasy, Cherkasy Oblast 18009
Ukraine
Municipal Enterprise "Bukovinian сlinical oncology сenter" ( Site 0139)
Chernivtsi, Chernivetska Oblast 58013
Ukraine
CNCE Precarpathian Clinical Oncologic Center ( Site 0131)
Ivano-Frankivsk, Ivano-Frankivsk Oblast 76018
Ukraine
MNPE LTMU Multidisc. Clin. Hosp. of Emerg. and Intens. Care ( Site 0132)
Lviv, Lviv Oblast 79059
Ukraine
ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 0460)
Rivne, Rivne Oblast 33010
Ukraine
Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council" ( Site 0135)
Vinnytsia, Vinnytsia Oblast 21029
Ukraine
Shalimov Institute of Surgery and Transplantation ( Site 0138)
Kyiv, 03126
Ukraine