A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator- Controlled Clinical Studyof Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumabin Participants With Resected Stage II, IIIA, IIIB (N2) Non-small Cell
Contact:
NCT Number:
Protocol:
Study Status:
Population:
Phase:
The purpose of this study is to evaluate the safety and effectiveness of the investigational drug V940 in combination with pembrolizumab for preventing relapse in non-small cell lung cancer. V940 is not yet approved by the U.S. Food and Drug Administration (FDA), which means it is still under investigation and has not been authorized for general use. Pembrolizumab, however, is an FDA-approved drug commonly used in cancer treatment. This study aims to determine how well V940 and pembrolizumab work together compared to a placebo combined with pembrolizumab. Additionally, it will assess the impact of this combination on participants' lifespan and quality of life. By comparing these outcomes with those of participants receiving a placebo with pembrolizumab, the study seeks to understand the potential benefits and risks of V940 in conjunction with pembrolizumab
Are you Eligible? (Inclusion Criteria)
- Is an individual of any sex/gender, from 18 years or older at the signing of the consent form 2. Has surgically resected (R0) and histologically confirmed diagnosis of pathological Stage II, IIIA, IIIB (with nodal involvement [N2]) squamous or nonsquamous NSCLC 3. Has received at least one dose of adjuvant treatment with standard of care platinum doublet chemotherapy up to 4 cycles (or equivalent dose of platinum doublet chemotherapy).