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

Launched by MERCK SHARP & DOHME LLC · Jan 17, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment that combines pembrolizumab, a type of immunotherapy, with other investigational agents for patients with early-stage non-small cell lung cancer (NSCLC) that can be surgically removed. The main goal is to find out how many people have no cancer cells left in their tumors or lymph nodes after receiving this treatment before surgery. Researchers also want to see if the treatment can shrink the cancer or make it disappear.

To participate in this trial, individuals must be between the ages of 65 and 74, have a confirmed diagnosis of resectable Stage II, IIIA, or IIIB NSCLC, and be able to undergo surgery. They should not have received any previous cancer treatments and must meet certain health criteria. If eligible, participants will receive the study treatment and then undergo surgery to remove their tumors, allowing researchers to evaluate the effectiveness of the therapy. It’s important to note that there are several health conditions and previous treatments that may exclude someone from participating, so it's essential to discuss these details with a healthcare provider.

Gender

ALL

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 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.

Trial Officials