RecruitingPhase 2NCT06788912

Pembrolizumab (MK-3475) Plus Investigational Agents in Resectable Non-small Cell Lung Cancer (NSCLC) (MK-3475-01E/KEYMAKER-U01)

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.

Checked against the public recordLast updated Jun 26, 2026 · Source: ClinicalTrials.gov

StatusRecruiting
PhasePhase 2
U.S. locations38
SponsorMerck Sharp & Dohme LLC
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Merck Sharp & Dohme LLC
Interventions being studied
Biological: Pembrolizumab (neoadjuvant); Drug: Cisplatin; Drug: Gemcitabine; Drug: Pemetrexed; Drug: Sacituzumab tirumotecan; Drug: H1 receptor antagonist; Drug: H2 receptor antagonist; Drug: Acetaminophen (or equivalent); Drug: Dexamethasone (or equivalent); Drug: Carboplatin; Biological: Pembrolizumab (adjuvant); Drug: Paclitaxel; Drug: Steroid mouthwash (dexamethasone or equivalent)
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Southern Cancer Center (SCC) ( Site 8004)Daphne, Alabama
  • Sansum Clinic (Ridley Tree) ( Site 8012)Santa Barbara, California
  • Rocky Mountain Cancer Centers (RMCC) ( Site 8011)Lone Tree, Colorado
  • MedStar Franklin Square Medical Center ( Site 0033)Baltimore, Maryland
  • Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8006)Eugene, Oregon
  • Texas Oncology - Central/South Texas ( Site 8009)Austin, Texas
  • Texas Oncology - Northeast Texas ( Site 8005)Tyler, Texas
  • Virginia Cancer Specialists (VCS) ( Site 8002)Fairfax, Virginia
  • Centro de Estudios Clínicos SAGA ( Site 0162)Santiago, Region M. de Santiago
  • FALP ( Site 0161)Santiago, Region M. de Santiago
  • Bradfordhill ( Site 0160)Santiago, Region M. de Santiago
  • Alexandra General Hospital of Athens Oncology-Hematology Unit ( Site 0203)Athens, Attica

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 26, 2026. Always confirm current availability with the study team.

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