Actively Recruiting
Pembrolizumab (MK-3475) Plus Investigational Agents in Resectable Non-small Cell Lung Cancer (NSCLC) (MK-3475-01E/KEYMAKER-U01)
Led by Merck Sharp & Dohme LLC · Updated on 2026-03-31
60
Participants Needed
34
Research Sites
359 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pembrolizumab (MK-3475) Plus Investigational Agents in Resectable Non-small Cell Lung Cancer (NSCLC) (MK-3475-01E/KEYMAKER-U01)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with pathologically confirmed, previously untreated resectable Stage II, IIIA, or IIIB (N2) non-small cell lung cancer
- Able to undergo the planned study therapy including necessary surgery
- Confirmed that EGFR-directed therapy is not suitable as primary treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 10 days before starting study treatment
- Able to provide archival or newly obtained biopsy of primary lung tumor or lymph node metastasis
You will not qualify if you...
- Tumor located in superior sulcus, or tumor type is large-cell neuroendocrine cancer, mixed small cell and non-small cell tumor, or sarcomatoid tumor
- Grade 2 or higher peripheral neuropathy
- History of severe dry eye syndrome, severe Meibomian gland disease, blepharitis, or severe corneal disease delaying healing
- Active or past inflammatory bowel disease requiring immunosuppressive medication
- Uncontrolled significant cardiovascular or cerebrovascular disease
- Received live or live-attenuated vaccine within 30 days before treatment
- Prior radiotherapy within 2 weeks before treatment or radiation toxicities requiring corticosteroids
- Immunodeficiency or receiving chronic systemic steroids exceeding 10 mg prednisone daily or other immunosuppressive therapy within 7 days before treatment
- Known progressing additional malignancy or malignancy treated within past 5 years
- Severe hypersensitivity (grade 3 or higher) to pembrolizumab or its excipients
- Active autoimmune disease requiring systemic treatment within the past 2 years (replacement therapy allowed)
- History of pneumonitis or interstitial lung disease requiring steroids or current pneumonitis/interstitial lung disease
- Active infection requiring systemic therapy
- Hepatitis B or C virus infection
- Known HIV infection
- History of allogeneic tissue or solid organ transplant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 34 locations
1
Southern Cancer Center (SCC) ( Site 8004)
Daphne, Alabama, United States, 36526
Actively Recruiting
2
Sansum Clinic (Ridley Tree) ( Site 8012)
Santa Barbara, California, United States, 93105
Actively Recruiting
3
Rocky Mountain Cancer Centers (RMCC) ( Site 8011)
Lone Tree, Colorado, United States, 80124
Actively Recruiting
4
MedStar Franklin Square Medical Center ( Site 0033)
Baltimore, Maryland, United States, 21237
Actively Recruiting
5
Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8006)
Eugene, Oregon, United States, 97401
Actively Recruiting
6
Texas Oncology - Central/South Texas ( Site 8009)
Austin, Texas, United States, 78705
Actively Recruiting
7
Texas Oncology - Northeast Texas ( Site 8005)
Tyler, Texas, United States, 75702
Actively Recruiting
8
Virginia Cancer Specialists (VCS) ( Site 8002)
Fairfax, Virginia, United States, 22031
Actively Recruiting
9
Centro de Estudios Clínicos SAGA ( Site 0162)
Santiago, Region M. de Santiago, Chile, 7500653
Actively Recruiting
10
FALP ( Site 0161)
Santiago, Region M. de Santiago, Chile, 7500921
Actively Recruiting
11
Bradfordhill ( Site 0160)
Santiago, Region M. de Santiago, Chile, 8420383
Actively Recruiting
12
Alexandra General Hospital of Athens Oncology-Hematology Unit ( Site 0203)
Athens, Attica, Greece, 115 28
Actively Recruiting
13
ATTIKON GENERAL UNIVERSITY HOSPITAL-Oncology ( Site 0202)
Athens, Attica, Greece, 12462
Actively Recruiting
14
Metropolitan Hospital-4th Oncology Dept ( Site 0201)
Athens, Attica, Greece, 185 47
Actively Recruiting
15
University General Hospital of Heraklion ( Site 0200)
Heraklion, Irakleio, Greece, 71110
Actively Recruiting
16
Petz Aladar Egyetemi Oktato Korhaz-Pulmonológia (Dr. Szalai Zsuzsanna) ( Site 0062)
Győr, Győr-Moson-Sopron, Hungary, 9024
Actively Recruiting
17
Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 0061)
Szolnok, Jász-Nagykun-Szolnok, Hungary, 5000
Actively Recruiting
18
Országos Korányi Pulmonológiai Intézet ( Site 0060)
Budapest, Hungary, 1121
Actively Recruiting
19
Azienda Ospedaliera Universitaria Careggi ( Site 0173)
Florence, Tuscany, Italy, 50134
Actively Recruiting
20
Ospedale San Raffaele. ( Site 0171)
Milan, Italy, 20132
Actively Recruiting
21
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0175)
Milan, Italy, 20133
Actively Recruiting
22
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0174)
Roma, Italy, 00168
Actively Recruiting
23
Wielkopolskie Centrum Pulmonologii i Torakochirurgii-Oddzial Onkologii Klinicznej z Pododdzialem Dz ( Site 0153)
Poznan, Greater Poland Voivodeship, Poland, 60-569
Actively Recruiting
24
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 0151)
Warsaw, Masovian Voivodeship, Poland, 02-781
Actively Recruiting
25
Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150)
Gdansk, Pomeranian Voivodeship, Poland, 80-952
Actively Recruiting
26
Hospital Clínic de Barcelona ( Site 0092)
Barcelona, Spain, 08008
Actively Recruiting
27
Hacettepe Universite Hastaneleri-oncology hospital ( Site 0700)
Ankara, Turkey (Türkiye), 06230
Actively Recruiting
28
CNE CC of Oncology Hematol ( Site 0130)
Cherkasy, Cherkasy Oblast, Ukraine, 18009
Actively Recruiting
29
Municipal Enterprise "Bukovinian сlinical oncology сenter" ( Site 0139)
Chernivtsi, Chernivetska Oblast, Ukraine, 58013
Actively Recruiting
30
CNCE Precarpathian Clinical Oncologic Center ( Site 0131)
Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine, 76018
Actively Recruiting
31
MNPE LTMU Multidisc. Clin. Hosp. of Emerg. and Intens. Care ( Site 0132)
Lviv, Lviv Oblast, Ukraine, 79059
Actively Recruiting
32
ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 0460)
Rivne, Rivne Oblast, Ukraine, 33010
Actively Recruiting
33
Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council" ( Site 0135)
Vinnytsia, Vinnytsia Oblast, Ukraine, 21029
Actively Recruiting
34
Shalimov Institute of Surgery and Transplantation ( Site 0138)
Kyiv, Ukraine, 03126
Actively Recruiting
Research Team
T
Toll Free Number
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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