Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
completion around

Description

Summary

The goal of this study is to evaluate V940 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 V940 plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS) as assessed by the investigator.

Official Title

A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With Resected Stage II, IIIA, IIIB (N2) Non-small Cell Lung Cancer (INTerpath-002)

Keywords

Non-small Cell Lung Cancer, Lung Neoplasms, Non-Small-Cell Lung Carcinoma, Pembrolizumab, V940 + Pembrolizumab

Eligibility

Locations

  • University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0030) accepting new patients
    Orange California 92868 United States
  • St. Joseph Hospital-The Center for Cancer Prevention and Treatment ( Site 0074) accepting new patients
    Orange California 92868 United States
  • UCLA Clinical & Translational Research Center (CTRC) ( Site 0059) accepting new patients
    Los Angeles California 90095 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Merck Sharp & Dohme LLC
Links
Merck Clinical Trials Information Plain Language Summary
ID
NCT06077760
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 868 study participants
Last Updated