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NCT07513376 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study, sponsored by Merck Sharp & Dohme.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 876
- Enrollment target
NCT07513376: Recruiting Phase 3 study, sponsored by Merck Sharp & Dohme.
NCT07513376 is a Phase 3 study that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 876 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (13% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07513376, a Phase 3 study, is actively recruiting participants, sponsored by Merck Sharp & Dohme.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 876 participants
- Enrollment target
Study Summary
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.
Primary Outcome
DFS is defined as the time from randomization to any recurrence (local, locoregional, regional, or distant) by BICR, or death due to any cause, whichever occurs first.
Interventions
- OTHER Placebo
- BIOLOGICAL Intismeran
- BIOLOGICAL Pembrolizumab coformulated with berahyaluronidase alfa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 876 participants |
| Start Date | 2026-05-04 |
| Est. Completion | 2038-05-11 |
| Phase | Phase 3 |
What NCT07513376 shows while recruiting
NCT07513376 is an interventional study that assigns participants to a tested intervention. The registered 876 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (13% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT07513376 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07513376 about?
NCT07513376 is a clinical study titled "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)". 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 prev...
What is the current status of trial NCT07513376?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 876 participants. The study started on 2026-05-04. Estimated completion is 2038-05-11.
What interventions are being tested in trial NCT07513376?
The interventions under investigation include: Placebo (OTHER), Intismeran (BIOLOGICAL), Pembrolizumab coformulated with berahyaluronidase alfa (BIOLOGICAL).
Who is sponsoring clinical trial NCT07513376?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07513376's enrollment target sits among peer trials
876 372nd of 2000 higher than 1,629 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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