Study on Pembrolizumab With or Without V940 for Non-Small Cell Lung Cancer

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06623422

This clinical trial is exploring whether adding the drug V940 to pembrolizumab after surgery can help people with non-small cell lung cancer (NSCLC) stay cancer-free longer compared to those who receive a placebo with pembrolizumab.

Patient Parameters

Program Overview

The purpose of this study is to find out if combining the drug V940 with pembrolizumab after surgery can help prevent non-small cell lung cancer (NSCLC) from returning in patients whose tumors did not fully respond to treatment before surgery. Researchers are comparing this combination to a placebo with pembrolizumab to see which is more effective in keeping patients cancer-free for a longer time.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of non-small cell lung cancer (NSCLC) that can be surgically removed and is at Stage II, IIIA, or IIIB (N2).
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have not achieved a complete response to chemotherapy and pembrolizumab before surgery.
  • Do not require treatment targeting specific EGFR mutations.
  • If HIV-positive, have well-controlled HIV on anti-retroviral therapy.
  • If hepatitis B positive, have been on antiviral therapy for at least 4 weeks with undetectable viral load.
  • If previously infected with hepatitis C, have an undetectable viral load at screening.

Exclusion Criteria

  • Have a diagnosis of small cell lung cancer or certain other types of lung tumors.
  • Have a specific gene rearrangement known as ALK.
  • Have received prior neoadjuvant therapy for the current lung cancer diagnosis.
  • Have previously been treated with certain immune therapies targeting PD-1, PD-L1, or similar pathways.
  • Have received other systemic cancer treatments not specified in this study.
  • Have been treated with a cancer vaccine before.
  • Have had recent radiotherapy within 2 weeks before starting the study treatment or have radiation-related side effects requiring steroids.
  • Have received a live vaccine within 30 days before starting the study treatment.

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