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Pembrolizumab (MK-3475) Plus Investigational Agents in Resectable Non-small Cell Lung Cancer (NSCLC) (MK-3475-01E/KEYMAKER-U01)
NCT06788912 · Merck Sharp & Dohme LLC
In plain English
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Official title
KEYMAKER-U01 Substudy 01E: A Phase 2 Umbrella Study With Rolling Arms of Investigational Agents With or Without Chemotherapy in Combination With Pembrolizumab in Treatment of Participants With Newly Diagnosed Resectable Stages II-IIIB (N2) Non-small Cell Lung Cancer (NSCLC)
About this study
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
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
* 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 either 0 or 1 as assessed within 10 days before initiation of study intervention.
* Is able to provide archival or newly obtained core/excisional biopsy of the primary lung tumor or lymph node metastasis.
Exclusion Criteria:
* Has one of the following tumor locations/types: NSCLC involving the superior sulcus, large-cell neuro-endocrine cancer, mixed tumors containing small cell and non-small cell elements, or sarcomatoid tumor.
* Has Grade ≥2 peripheral neuropathy.
* Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea).
* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
* Received prior radiotherapy within 2 weeks of start of study intervention, or radiation related toxicities, requiring corticosteroids.
* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.
* Known additional malignancy that is progressing or has required active treatment within the past 5 years.
* Severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
* Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid) is allowed.
* History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
* Active infection requiring systemic therapy.
* Hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] reactive) or Hepatitis C virus (defined as detectable hepatitis C virus (HCV) ribonucleic acid (RNA) \[qualitative\]) infection.
* Known history of human immunodeficiency virus (HIV) infection.
* History of allogeneic tissue/solid organ transplant.
Study design
Enrollment target: 60 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-03-20
Estimated completion: 2032-02-06
Last updated: 2026-03-31
Interventions
Biological: Pembrolizumab (neoadjuvant)Drug: CisplatinDrug: GemcitabineDrug: PemetrexedDrug: Sacituzumab tirumotecanDrug: H1 receptor antagonistDrug: H2 receptor antagonistDrug: Acetaminophen (or equivalent)Drug: Dexamethasone (or equivalent)Drug: CarboplatinBiological: Pembrolizumab (adjuvant)Drug: PaclitaxelDrug: Steroid mouthwash (dexamethasone or equivalent)
Primary outcomes
- • Pathological Complete Response (pCR) (Up to approximately 20 weeks)
- • Percent Residual Viable Tumor (%RVT) (Up to approximately 20 weeks)
Sponsor
Merck Sharp & Dohme LLC · industry
Contacts & investigators
ContactToll Free Number · contact · Trialsites@msd.com · 1-888-577-8839
InvestigatorMedical Director · study_director, Merck Sharp & Dohme LLC
All locations (34)
Southern Cancer Center (SCC) ( Site 8004)Recruiting
Daphne, Alabama, United States
Sansum Clinic (Ridley Tree) ( Site 8012)Recruiting
Santa Barbara, California, United States
Rocky Mountain Cancer Centers (RMCC) ( Site 8011)Recruiting
Lone Tree, Colorado, United States
MedStar Franklin Square Medical Center ( Site 0033)Recruiting
Baltimore, Maryland, United States
Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8006)Recruiting
Eugene, Oregon, United States
Texas Oncology - Central/South Texas ( Site 8009)Recruiting
Austin, Texas, United States
Texas Oncology - Northeast Texas ( Site 8005)Recruiting
Tyler, Texas, United States
Virginia Cancer Specialists (VCS) ( Site 8002)Recruiting
Fairfax, Virginia, United States
Centro de Estudios Clínicos SAGA ( Site 0162)Recruiting
Santiago, Region M. de Santiago, Chile
FALP ( Site 0161)Recruiting
Santiago, Region M. de Santiago, Chile
Bradfordhill ( Site 0160)Recruiting
Santiago, Region M. de Santiago, Chile
Alexandra General Hospital of Athens Oncology-Hematology Unit ( Site 0203)Recruiting
Athens, Attica, Greece
ATTIKON GENERAL UNIVERSITY HOSPITAL-Oncology ( Site 0202)Recruiting
Athens, Attica, Greece
Metropolitan Hospital-4th Oncology Dept ( Site 0201)Recruiting
Athens, Attica, Greece
University General Hospital of Heraklion ( Site 0200)Recruiting
Heraklion, Irakleio, Greece
Petz Aladar Egyetemi Oktato Korhaz-Pulmonológia (Dr. Szalai Zsuzsanna) ( Site 0062)Recruiting
Győr, Győr-Moson-Sopron, Hungary
Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 0061)Recruiting
Szolnok, Jász-Nagykun-Szolnok, Hungary
Országos Korányi Pulmonológiai Intézet ( Site 0060)Recruiting
Budapest, Hungary
Azienda Ospedaliera Universitaria Careggi ( Site 0173)Recruiting
Florence, Tuscany, Italy
Ospedale San Raffaele. ( Site 0171)Recruiting
Milan, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0175)Recruiting
Milan, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0174)Recruiting
Roma, Italy
Wielkopolskie Centrum Pulmonologii i Torakochirurgii-Oddzial Onkologii Klinicznej z Pododdzialem Dz ( Site 0153)Recruiting
Poznan, Greater Poland Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 0151)Recruiting
Warsaw, Masovian Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150)Recruiting
Gdansk, Pomeranian Voivodeship, Poland
Hospital Clínic de Barcelona ( Site 0092)Recruiting
Barcelona, Spain
Hacettepe Universite Hastaneleri-oncology hospital ( Site 0700)Recruiting
Ankara, Turkey (Türkiye)
CNE CC of Oncology Hematol ( Site 0130)Recruiting
Cherkasy, Cherkasy Oblast, Ukraine
Municipal Enterprise "Bukovinian сlinical oncology сenter" ( Site 0139)Recruiting
Chernivtsi, Chernivetska Oblast, Ukraine
CNCE Precarpathian Clinical Oncologic Center ( Site 0131)Recruiting
Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine
MNPE LTMU Multidisc. Clin. Hosp. of Emerg. and Intens. Care ( Site 0132)Recruiting
Lviv, Lviv Oblast, Ukraine
ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 0460)Recruiting
Rivne, Rivne Oblast, Ukraine
Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council" ( Site 0135)Recruiting
Vinnytsia, Vinnytsia Oblast, Ukraine
Shalimov Institute of Surgery and Transplantation ( Site 0138)Recruiting
Kyiv, Ukraine