Study of V940 Plus Pembrolizumab Versus Placebo Plus Pembrolizumab in Patients with Non-Small Cell Lung Cancer

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06077760

This clinical trial is comparing the effects of a new drug combination, V940 plus pembrolizumab, against a placebo plus pembrolizumab in patients who have had surgery to remove non-small cell lung cancer. The study aims to see if the new combination can help patients live longer without the cancer returning.

Patient Parameters

Program Overview

The purpose of this study is to test whether a new treatment combining V940 and pembrolizumab is more effective than a placebo with pembrolizumab in preventing the return of non-small cell lung cancer (NSCLC) after surgery. The study focuses on patients with Stage II, IIIA, or IIIB NSCLC who have had their cancer completely removed by surgery. Researchers want to find out if this new combination can help patients stay cancer-free for longer compared to the current standard treatment.

Eligibility Criteria

Inclusion Criteria

  • Have had surgery to completely remove non-small cell lung cancer (NSCLC) and have Stage II, IIIA, or IIIB cancer according to specific medical guidelines.
  • Show no signs of cancer before starting the study.
  • Have received at least one dose of standard chemotherapy after surgery.
  • Start the study treatment within 24 weeks after surgery.
  • If positive for hepatitis B, must have been on antiviral treatment for at least 4 weeks and have no detectable virus.
  • If previously infected with hepatitis C, must have no detectable virus at screening.
  • If living with HIV, must have well-controlled HIV on medication.

Exclusion Criteria

  • Have small cell lung cancer or certain types of mixed tumors.
  • Have HIV with a history of specific related diseases.
  • Have received certain cancer treatments before for the current lung cancer.
  • Have had or are planning to have radiation therapy for the current lung cancer.
  • Have previously received treatments targeting specific immune checkpoints.
  • Have had any cancer treatment or experimental drugs within 4 weeks before starting the study.
  • Have received a live vaccine within 30 days before starting the study.
  • Have an immune system deficiency or are on high-dose steroids or other immune-suppressing treatments.
  • Have another active cancer that needed treatment in the last 5 years.
  • Have an active autoimmune disease needing treatment in the last 2 years.
  • Have a history of lung inflammation needing steroids or have current lung inflammation.
  • Have an active infection needing treatment.

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