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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 is a Phase 3 study that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 876 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07513376
The ClinicalTrials.gov registry entry for NCT07513376 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 876 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT07513376 reports 0 study locations.
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.
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