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

Recruiting now · Phase 2

Conditions studied: Lung Neoplasm Malignant

In brief

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.

Key facts

Study ID

NCT06788912

Run by

Merck Sharp & Dohme LLC

People needed

60

Starts

2025-03-20

Expected to finish

2032-02-06

Last updated by the study team

2026-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Southern Cancer Center (SCC) ( Site 8004) — Daphne, Alabama, United States (enrolling)
• Sansum Clinic (Ridley Tree) ( Site 8012) — Santa Barbara, California, United States (enrolling)
• Rocky Mountain Cancer Centers (RMCC) ( Site 8011) — Lone Tree, Colorado, United States (enrolling)
• MedStar Franklin Square Medical Center ( Site 0033) — Baltimore, Maryland, United States (enrolling)
• Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8006) — Eugene, Oregon, United States (enrolling)
• Texas Oncology - Central/South Texas ( Site 8009) — Austin, Texas, United States (enrolling)
• Texas Oncology - Northeast Texas ( Site 8005) — Tyler, Texas, United States (enrolling)
• Virginia Cancer Specialists (VCS) ( Site 8002) — Fairfax, Virginia, United States (enrolling)
• Centro de Estudios Clínicos SAGA ( Site 0162) — Santiago, Region M. de Santiago, Chile (enrolling)
• FALP ( Site 0161) — Santiago, Region M. de Santiago, Chile (enrolling)
• Bradfordhill ( Site 0160) — Santiago, Region M. de Santiago, Chile (enrolling)
• Alexandra General Hospital of Athens Oncology-Hematology Unit ( Site 0203) — Athens, Attica, Greece (enrolling)
• ATTIKON GENERAL UNIVERSITY HOSPITAL-Oncology ( Site 0202) — Athens, Attica, Greece (enrolling)
• Metropolitan Hospital-4th Oncology Dept ( Site 0201) — Athens, Attica, Greece (enrolling)
• University General Hospital of Heraklion ( Site 0200) — Heraklion, Irakleio, Greece (enrolling)
• Petz Aladar Egyetemi Oktato Korhaz-Pulmonológia (Dr. Szalai Zsuzsanna) ( Site 0062) — Győr, Győr-Moson-Sopron, Hungary (enrolling)
• Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 0061) — Szolnok, Jász-Nagykun-Szolnok, Hungary (enrolling)
• Országos Korányi Pulmonológiai Intézet ( Site 0060) — Budapest, Hungary (enrolling)
• Azienda Ospedaliera Universitaria Careggi ( Site 0173) — Florence, Tuscany, Italy (enrolling)
• Ospedale San Raffaele. ( Site 0171) — Milan, Italy (enrolling)
• Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0175) — Milan, Italy (enrolling)
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0174) — Roma, Italy (enrolling)
• Wielkopolskie Centrum Pulmonologii i Torakochirurgii-Oddzial Onkologii Klinicznej z Pododdzialem Dz ( Site 0153) — Poznan, Greater Poland Voivodeship, Poland (enrolling)
• Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 0151) — Warsaw, Masovian Voivodeship, Poland (enrolling)
• Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150) — Gdansk, Pomeranian Voivodeship, Poland (enrolling)

Full record on ClinicalTrials.gov

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