Actively Recruiting
A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) in High-Risk Stage I Non-Small Cell Lung Cancer (V940-014)
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-13
876
Participants Needed
3
Research Sites
627 weeks
Total Duration
On this page
Sponsors
M
Merck Sharp & Dohme LLC
Lead Sponsor
M
ModernaTX, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are looking for new ways to treat high-risk, localized non-small cell lung cancer (NSCLC) that has been removed with surgery. People with high-risk, localized NSCLC are often treated with surgery. Researchers want to learn if participants can receive 1 or 2 trial treatments to help prevent NSCLC from coming back after surgery. One trial medicine is intismeran (also called V940/mRNA-4157) and the other is subcutaneous pembrolizumab (also called SC pembrolizumab and MK-3475A). Intismeran is designed to help a person's immune system attack their specific cancer. SC pembrolizumab is an immunotherapy treatment which helps the immune system fight cancer. The main purpose of this study is to evaluate whether adjuvant intismeran autogene (V940) in combination with SC pembrolizumab and berahyaluronidase alfa (MK-3475A) or intismeran monotherapy improves disease-free survival (DFS) compared with placebo in participants with completely resected high-risk Stage I NSCLC.
CONDITIONS
Official Title
A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) in High-Risk Stage I Non-Small Cell Lung Cancer (V940-014)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological diagnosis of pathological Stage I non-small cell lung cancer (tumor 64 cm) with at least one high-risk feature (tumor size >2cm, visceral pleural invasion, lymphovascular invasion, or high-grade histology)
- Complete surgical removal of primary NSCLC
- No prior treatment other than surgery for current Stage I NSCLC
- Provided tissue sample from recent surgery and required blood sample
- HIV-infected participants must have well-controlled HIV on antiretroviral therapy
- Hepatitis B surface antigen positive participants eligible if on antiviral therapy for at least 4 weeks with undetectable viral load
- Participants with history of hepatitis C infection eligible if viral load is undetectable at screening
You will not qualify if you...
- Diagnosis of small cell lung cancer, mixed tumors with small cell elements, neuroendocrine tumor with large cell components, sarcomatoid carcinoma, or two synchronous primary NSCLCs
- Clinically significant cardiovascular disease within 12 months before randomization, including recent heart procedures or unstable heart conditions
- HIV-infected participants with history of Kaposi's sarcoma or Multicentric Castleman's Disease
- Known additional malignancy progressing or requiring treatment in past 3 years
- Active autoimmune disease requiring systemic treatment in past 2 years (hormonal supplementation allowed)
- History of pneumonitis or interstitial lung disease requiring steroids or current pneumonitis/interstitial lung disease
- Active infection requiring systemic therapy (unless permitted by protocol)
- History of stem cell or solid organ transplant
- Not fully recovered from major surgery or ongoing surgical complications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
NHO Revive Research Institute, LLC ( Site 3218)
Lincoln, Nebraska, United States, 68506
Actively Recruiting
2
Renown Regional Medical Center-Renown Health Medical Oncology ( Site 3207)
Reno, Nevada, United States, 89502
Actively Recruiting
3
One Clinical Research ( Site 0501)
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
Research Team
T
Toll Free Number
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here