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Pembrolizumab combined with other treatments for resectable non-small cell lung cancer

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)

Phase 2 Interventional Merck Sharp & Dohme LLC · NCT06788912

This study is testing if combining the immunotherapy drug Pembrolizumab with chemotherapy can help people with resectable non-small cell lung cancer have better surgery results by reducing tumor size and cancer cells before surgery.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment60 (estimated)
Ages18 Years and up
SexAll
SponsorMerck Sharp & Dohme LLC Industry-sponsored
Drugs / interventionspembrolizumab, radiation, prednisone
Locations34 sites (Daphne, Alabama and 33 other locations)
Trial IDNCT06788912 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of Pembrolizumab, an immunotherapy drug, in combination with other chemotherapy agents for patients with resectable non-small cell lung cancer (NSCLC). The treatment is administered before surgery, and the primary goals are to assess the absence of cancer cells in removed tumors and lymph nodes, as well as to evaluate tumor size reduction. Participants will undergo necessary surgical procedures following the neoadjuvant treatment. The study aims to gather data on the efficacy of this combination therapy in improving surgical outcomes.

Who should consider this trial

Good fit: Ideal candidates are individuals with previously untreated, pathologically confirmed resectable Stage II, IIIA, or IIIB non-small cell lung cancer.

Not a fit: Patients with specific tumor types or locations, such as large-cell neuro-endocrine cancer or those with significant peripheral neuropathy, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved surgical outcomes and potentially higher rates of cancer remission for patients with NSCLC.

How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches in treating NSCLC, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Daphne, Alabama and 33 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
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Conditions Lung Neoplasm MalignantProgrammed Cell Death-1Programmed Cell Death 1 Ligand 1Programmed Cell Death 1 Ligand 2
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.