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)
Public ClinicalTrials.gov record NCT07513376. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Randomized, Placebo-Controlled Study of Adjuvant Intismeran Autogene Plus Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) or Intismeran Autogene Monotherapy Versus Placebo in Participants With Completely Resected High-Risk Stage I Non-Small Cell Lung Cancer (INTerpath-014)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07513376
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 876 participants
Conditions and interventions
Conditions
Interventions
- Intismeran Biological
- Pembrolizumab coformulated with berahyaluronidase alfa Biological
- Placebo Other
Biological · Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 4, 2026 (Actual)
- Primary completion
- Aug 22, 2034 (Estimated)
- Completion
- May 11, 2038 (Estimated)
- Last update posted
- Oct 9, 2026
2026 – 2038
United States locations
- U.S. sites
- 23
- U.S. states
- 18
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UC Davis Comprehensive Cancer Center ( Site 3204) | Sacramento | California | 95817 | Recruiting |
| University of Colorado Cancer Center ( Site 3268) | Aurora | Colorado | 80045 | Recruiting |
| Smilow Cancer Center at Yale-New Haven ( Site 3253) | New Haven | Connecticut | 06511 | Recruiting |
| UF Health Cancer Center ( Site 3257) | Gainesville | Florida | 32610 | Recruiting |
| Illinois Cancer Care ( Site 7000) | Peoria | Illinois | 61615 | Recruiting |
| Washington University School of Medicine ( Site 3279) | St Louis | Missouri | 63110 | Recruiting |
| Billings Clinic ( Site 3255) | Billings | Montana | 59101 | Recruiting |
| NHO Revive Research Institute, LLC ( Site 3218) | Lincoln | Nebraska | 68506 | Recruiting |
| Renown Regional Medical Center-Renown Health Medical Oncology ( Site 3207) | Reno | Nevada | 89502 | Recruiting |
| New York Oncology Hematology, P.C. ( Site 9000) | Albany | New York | 12206 | Recruiting |
| White Plains Hospital ( Site 3213) | White Plains | New York | 10601 | Recruiting |
| Charles George VA Medical Center ( Site 3233) | Asheville | North Carolina | 28805 | Recruiting |
| UNC Lineberger Comprehensive Cancer Center ( Site 3250) | Chapel Hill | North Carolina | 27514 | Recruiting |
| WakeMed Raleigh Campus ( Site 3214) | Raleigh | North Carolina | 27610 | Recruiting |
| Sanford Fargo Medical Center ( Site 3236) | Fargo | North Dakota | 58102 | Recruiting |
| Altru Health System ( Site 3254) | Grand Forks | North Dakota | 58201 | Recruiting |
| Perelman Center for Advanced Medicine ( Site 3205) | Philadelphia | Pennsylvania | 19104 | Recruiting |
| Sanford Cancer Center ( Site 3266) | Sioux Falls | South Dakota | 57104 | Recruiting |
| Avera Cancer Institute ( Site 3209) | Sioux Falls | South Dakota | 57105 | Recruiting |
| The University of Tennessee Medical Center ( Site 3223) | Knoxville | Tennessee | 37920 | Recruiting |
| Hematology Oncology Associates of Fredericksburg ( Site 3275) | Fredericksburg | Virginia | 22408 | Recruiting |
| West Virginia University ( Site 3237) | Morgantown | West Virginia | 26506 | Recruiting |
| Gundersen Health System ( Site 3200) | La Crosse | Wisconsin | 54601 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 94 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07513376, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 9, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07513376 live on ClinicalTrials.gov.