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

Last updated: July 14, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

2

Condition

Neoplasms

Treatment

Pemetrexed

Carboplatin

Pembrolizumab (neoadjuvant)

Clinical Study ID

NCT06788912
3475-01E
2023-509234-19-00
U1111-1299-6753
2023-509234-19
MK-3475-01E
KEYMAKER-U01
  • Ages > 18
  • All Genders

Study Summary

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

Inclusion

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, orIIIB (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 notindicated as primary therapy

  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1as assessed within 10 days before initiation of study intervention.

  • Is able to provide archival or newly obtained core/excisional biopsy of the primarylung tumor or lymph node metastasis.

Exclusion

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-smallcell elements, or sarcomatoid tumor.

  • Has Grade ≥2 peripheral neuropathy.

  • Has history of documented severe dry eye syndrome, severe Meibomian gland diseaseand/or blepharitis, or severe corneal disease that prevents/delays corneal healing.

  • Has active inflammatory bowel disease requiring immunosuppressive medication orprevious history of inflammatory bowel disease (eg, Crohn's disease, ulcerativecolitis, 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 ofstudy intervention

  • Received prior radiotherapy within 2 weeks of start of study intervention, orradiation related toxicities, requiring corticosteroids.

  • Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (indosing exceeding 10 mg daily of prednisone equivalent) or any other form ofimmunosuppressive therapy within 7 days prior to the first dose of studyintervention.

  • Known additional malignancy that is progressing or has required active treatmentwithin 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) isallowed.

  • History of (noninfectious) pneumonitis/interstitial lung disease that requiredsteroids or has current pneumonitis/interstitial lung disease.

  • Active infection requiring systemic therapy.

  • Hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or Hepatitis Cvirus (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

Total Participants: 60
Treatment Group(s): 14
Primary Treatment: Pemetrexed
Phase: 2
Study Start date:
March 20, 2025
Estimated Completion Date:
February 07, 2032

Connect with a study center

  • Bradfordhill ( Site 0160)

    Santiago, Region M. De Santiago 8420383
    Chile

    Active - Recruiting

  • FALP ( Site 0161)

    Santiago, Region M. De Santiago 7500921
    Chile

    Active - Recruiting

  • Centro de Estudios Clínicos SAGA ( Site 0162)

    Santiago., Region M. De Santiago 7500653
    Chile

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Careggi ( Site 0173)

    Firenze, Toscana 50134
    Italy

    Active - Recruiting

  • Ospedale San Raffaele. ( Site 0171)

    Milano, 20132
    Italy

    Active - Recruiting

  • Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150)

    Gdansk, Pomorskie 80-952
    Poland

    Active - Recruiting

  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii-Oddzial Onkologii Klinicznej z Pododdzialem Dz ( Site 0153)

    Poznan, Wielkopolskie 60-569
    Poland

    Active - Recruiting

  • Hacettepe Universite Hastaneleri-oncology hospital ( Site 0700)

    Ankara, 06230
    Turkey

    Active - Recruiting

  • CNE CC of Oncology Hematol ( Site 0130)

    Cherkasy, Cherkaska Oblast 18009
    Ukraine

    Active - Recruiting

  • MNPE LTMU Multidisc. Clin. Hosp. of Emerg. and Intens. Care ( Site 0132)

    Lviv, Lvivska Oblast 79059
    Ukraine

    Active - Recruiting

  • MedStar Franklin Square Medical Center ( Site 0033)

    Baltimore, Maryland 21237
    United States

    Active - Recruiting

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