A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002)

The goal of this study is to evaluate intismeran autogene plus pembrolizumab versus placebo plus pembrolizumab for the adjuvant treatment of margin negative, completely resected Stage II, IIIA, IIIB (with nodal involvement \[N2\]) non-small cell lung cancer (NSCLC). The primary hypothesis is that intismeran autogene plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS) as assessed by the investigator.

Trial Details

NCT ID
NCT06077760
Phase
PHASE3
Sponsor
Merck Sharp & Dohme LLC
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • Intismeran autogene
  • Pembrolizumab
  • Placebo
Locations (sample)
  • Anchorage, Alaska, United States|61.21806,-149.90028
  • Tucson, Arizona, United States|32.22174,-110.92648
  • Yuma, Arizona, United States|32.72532,-114.6244
  • Los Angeles, California, United States|34.05223,-118.24368
  • Newport Beach, California, United States|33.61891,-117.92895

Key Eligibility Criteria

  • The main inclusion criteria include but are not limited to the following:
  • Has undergone margin negative, completely resected non-small cell lung cancer (NSCLC), and has pathological Stage II, IIIA, IIIB (N2) squamous or n…
  • Has no evidence of disease before randomization.
  • Has received at least one dose of adjuvant treatment with standard of care platinum doublet chemotherapy.

For full eligibility, visit ClinicalTrials.gov.

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