Actively Recruiting
A Phase 3, Randomized, Placebo-Controlled Study of Adjuvant Intismeran Autogene Plus Subcutaneous Pembrolizumab and Berahyaluronidase Alfa or Intismeran Monotherapy Versus Placebo in Completely Resected High-Risk Stage I Non-Small Cell Lung Cancer
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-28
876
Participants Needed
7
Research Sites
194 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 investigating new treatments for people with high-risk, localized non-small cell lung cancer (NSCLC) that has been completely removed by surgery. This study aims to learn if one or two investigational treatments can help prevent the cancer from returning. The main goal is to see if adjuvant intismeran autogene (V940), given alone or combined with subcutaneous pembrolizumab and berahyaluronidase alfa, improves disease-free survival compared to placebo in patients with completely resected high-risk Stage I NSCLC. Participants will be randomly assigned to one of three groups: one group receives intismeran via intramuscular injection plus pembrolizumab coformulated with berahyaluronidase alfa via subcutaneous injection; another group receives only intismeran via intramuscular injection; and the third group receives a placebo injection matching the intismeran dose. The study treatments are given to evaluate their effects on preventing cancer recurrence after surgery. During the study, participants will be monitored for disease-free survival through blinded independent central review for up to approximately 98 months. Additional measures include distant metastasis-free survival, overall survival, and quality of life assessments. Researchers will also track adverse events and study treatment discontinuations for up to about 144 months. Participants will provide tissue and blood samples and undergo regular assessments to evaluate safety and treatment effects throughout the study period.
CONDITIONS
Brief 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 ≤4 cm) with at least one high-risk feature: tumor size >2 cm, visceral pleural invasion, lymphovascular invasion, or high-grade histology
- Complete surgical resection of the primary NSCLC
- No prior treatment except definitive 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 must have received antiviral therapy for at least 4 weeks with undetectable viral load
- Participants with history of hepatitis C infection must have undetectable viral load 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 severe heart failure
- HIV-infected participants with history of Kaposi's sarcoma or Multicentric Castleman's Disease
- Known additional malignancy progressing or requiring treatment within past 3 years
- Active autoimmune disease requiring systemic treatment in past 2 years (hormonal supplementation allowed)
- History or current pneumonitis/interstitial lung disease requiring steroids
- Active infection requiring systemic therapy except those allowed by protocol
- History of stem cell or solid organ transplant
- Incomplete recovery or ongoing complications from major surgery
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 123 months
Participants receive injections of Intismeran with or without Pembrolizumab coformulated with Berahyaluronidase Alfa, or a placebo, as part of their assigned treatment arm.
Regular visits as per treatment schedule
Trial Site Locations
Total: 7 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
Altru Health System ( Site 3254)
Grand Forks, North Dakota, United States, 58201
Actively Recruiting
4
One Clinical Research ( Site 0501)
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
5
Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 2503)
Kingston, Ontario, Canada, K7L 2V7
Actively Recruiting
6
Centre Hospitalier de l'Université de Montréal ( Site 2501)
Montreal, Quebec, Canada, H2X 3E4
Actively Recruiting
7
National Cheng Kung University Hospital ( Site 5300)
Tainan, Taiwan, 704
Actively Recruiting
Research Team
T
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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