Actively Recruiting
KEYMAKER-U01 Substudy 01E: Investigational Agents With or Without Chemotherapy Combined With Pembrolizumab for Newly Diagnosed Resectable Stages II-IIIB (N2) Non-small Cell Lung Cancer
Led by Merck Sharp & Dohme LLC · Updated on 2026-06-01
60
Participants Needed
37
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for people with newly diagnosed, resectable stages II to IIIB (N2) non-small cell lung cancer (NSCLC). The study aims to measure how many participants have no signs of cancer cells in tumors and lymph nodes after treatment before surgery, and whether the cancer shrinks or disappears by assessing living cancer cells in the tumor removed during surgery. This is a phase 2 study sponsored by Merck Sharp & Dohme LLC. Participants receive neoadjuvant treatment before surgery with pembrolizumab combined either with platinum-based chemotherapy (cisplatin, gemcitabine, pemetrexed, paclitaxel, or carboplatin) or with sacituzumab tirumotecan. Pembrolizumab is given every three weeks for 4 cycles before surgery. After surgery, participants receive pembrolizumab every three weeks for 13 cycles. Some may also receive additional chemotherapy after surgery at the investigator's discretion. During the study, participants undergo surgery to remove tumors and lymph nodes. Researchers assess the pathological complete response and percent of residual viable tumor up to about 20 weeks after treatment. Safety is monitored for up to five years, including adverse events, survival outcomes, and hospital-related measures. The total study duration includes pre-surgery treatment, surgery, post-surgery treatment, and long-term follow-up.
CONDITIONS
Brief 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...
- Has previously untreated and pathologically confirmed resectable Stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC)
- Able to undergo protocol therapy, including necessary surgery
- Confirmation that epidermal growth factor receptor (EGFR) -directed therapy is not indicated as primary therapy
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 10 days before starting study treatment
- Able to provide archival or newly obtained core/excisional biopsy of the primary lung tumor or lymph node metastasis
You will not qualify if you...
- Tumors involving the superior sulcus, large-cell neuro-endocrine cancer, mixed small cell and non-small cell elements, or sarcomatoid tumor
- Grade 2 or higher peripheral neuropathy
- Severe dry eye syndrome, Meibomian gland disease, blepharitis, or severe corneal disease delaying corneal healing
- Active inflammatory bowel disease requiring immunosuppressive medication or history of inflammatory bowel disease
- Uncontrolled significant cardiovascular or cerebrovascular disease
- Received live or live-attenuated vaccine within 30 days before first study dose
- Prior radiotherapy within 2 weeks or radiation-related toxicities requiring corticosteroids
- Immunodeficiency or chronic steroid therapy exceeding 10 mg prednisone equivalent daily within 7 days before first dose
- Known additional progressing malignancy requiring treatment within past 5 years
- Severe hypersensitivity (Grade 3 or higher) to pembrolizumab or its components
- Active autoimmune disease requiring systemic treatment in past 2 years (replacement therapy allowed)
- History or current pneumonitis/interstitial lung disease requiring steroids
- 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 12 weeks (4 cycles of 21-day or 14-day cycles depending on treatment)
Participants receive pembrolizumab and either platinum-based chemotherapy or sacituzumab tirumotecan before surgery.
Every 2 or 3 weeks for up to 4 to 6 cycles, depending on assigned treatment
Duration - Single day for surgery plus immediate post-operative care
Participants undergo surgery to remove the lung tumor after completing neoadjuvant treatment.
1 surgical visit plus immediate post-operative care visits
Duration - Up to approximately 39 weeks (13 cycles of 21-day cycles)
After surgery, participants receive pembrolizumab for up to 13 cycles, with optional platinum-based chemotherapy at investigator discretion.
Every 3 weeks for up to 13 cycles, with additional visits if chemotherapy is given
Duration - Up to approximately 5 years
Participants are monitored for safety and long-term outcomes after completing treatment.
Periodic visits for assessments during follow-up
Trial Site Locations
Total: 37 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 Clinic de Barcelona ( Site 0092)
Barcelona, Spain, 08008
Actively Recruiting
27
Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 0702)
Adana, Turkey (Türkiye), 01250
Actively Recruiting
28
Hacettepe Universite Hastaneleri-oncology hospital ( Site 0700)
Ankara, Turkey (Türkiye), 06230
Actively Recruiting
29
İzmir Suat Seren Chest Disease Training & Research Hospital ( Site 0701)
Izmir, Turkey (Türkiye), 35110
Actively Recruiting
30
Ondokuz Mayıs Universitesi-Oncology department ( Site 0706)
Samsun, Turkey (Türkiye), 55139
Actively Recruiting
31
CNE CC of Oncology Hematol ( Site 0130)
Cherkasy, Cherkasy Oblast, Ukraine, 18009
Actively Recruiting
32
Municipal Enterprise "Bukovinian сlinical oncology сenter" ( Site 0139)
Chernivtsi, Chernivetska Oblast, Ukraine, 58013
Actively Recruiting
33
CNCE Precarpathian Clinical Oncologic Center ( Site 0131)
Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine, 76018
Actively Recruiting
34
MNPE LTMU Multidisc. Clin. Hosp. of Emerg. and Intens. Care ( Site 0132)
Lviv, Lviv Oblast, Ukraine, 79059
Actively Recruiting
35
ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 0460)
Rivne, Rivne Oblast, Ukraine, 33010
Actively Recruiting
36
Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council" ( Site 0135)
Vinnytsia, Vinnytsia Oblast, Ukraine, 21029
Actively Recruiting
37
Shalimov Institute of Surgery and Transplantation ( Site 0138)
Kyiv, Ukraine, 03126
Actively Recruiting
Research Team
T
Toll Free Number
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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