Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07513376 | 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) | PHASE3 | RECRUITING | 876 | — | — | May 4, 2026 | May 11, 2038 | May 28, 2026 | 7 | United States, Australia +2 |
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.
| Arm | Type | Description |
|---|---|---|
| Arm A: Intismeran + Pembrolizumab with Berahyaluronidase Alfa | EXPERIMENTAL | Participants will receive intismeran 1 mg via intramuscular (IM) injection plus pembrolizumab coformulated with berahyaluronidase alfa 790 mg via subcutaneous (SC) injection. |
| Arm B: Intismeran | EXPERIMENTAL | Participants will receive intismeran 1 mg via IM injection. |
| Arm C: Placebo | PLACEBO_COMPARATOR | Participants will receive dose-matched placebo via IM injection. |
| Name | Type | Description |
|---|---|---|
| Intismeran | BIOLOGICAL | IM injection |
| Pembrolizumab coformulated with berahyaluronidase alfa | BIOLOGICAL | SC injection |
| Placebo | OTHER | IM injection |
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has a histological diagnosis of pathological Stage I (tumor ≤4 cm) non-small cell lung cancer (NSCLC) per American Joint Committee on Cancer (AJCC) 9th Edition with at least 1of the following high-risk ...