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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 1 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Sep 18, 2026 · Source: ClinicalTrials.gov
The study is underway but is not accepting new participants.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Merck Sharp & Dohme LLC
- Interventions being studied
- Biological: Intismeran autogene; Biological: Pembrolizumab; Other: Placebo
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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 nonsquamous tumor, node, metastasis (TNM) staging per American Joint Committee on Cancer (AJCC) Eighth Edition guidelines.
- Has no evidence of disease before randomization.
- Has received at least one dose of adjuvant treatment with standard of care platinum doublet chemotherapy.
- No more than 24 weeks have elapsed between surgical resection of curative intent and the first dose of pembrolizumab.
- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization.
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART).
The main
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Alaska Oncology and Hematology ( Site 0039)Anchorage, Alaska
- The University of Arizona Cancer Center - North Campus ( Site 0071)Tucson, Arizona
- YUMA REGIONAL MEDICAL CENTER CANCER CENTER ( Site 0020)Yuma, Arizona
- UCLA Clinical & Translational Research Center (CTRC) ( Site 0059)Los Angeles, California
- Hoag Memorial Hospital Presbyterian ( Site 4042)Newport Beach, California
- Hoag Memorial Hospital Presbyterian ( Site 4048)Newport Beach, California
- St. Joseph Hospital-The Center for Cancer Prevention and Treatment ( Site 0074)Orange, California
- University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0030)Orange, California
- UCHealth Memorial Hospital-Heme Onc ( Site 0052)Colorado Springs, Colorado
- George Washington University Medical Faculty Associates ( Site 4064)Washington D.C., District of Columbia
- Mayo Clinic Florida ( Site 4043)Jacksonville, Florida
- Miami Cancer Institute at Baptist Health, Inc. ( Site 4047)Miami, Florida
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 18, 2026. Always confirm current availability with the study team.