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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05557591 | A Trial to Learn How the Cancer Vaccine BNT116 in Combination With Cemiplimab Works and How Safe the Combination is in Adults With Advanced Non-small Cell Lung Cancer (EMPOWERVAX Lung 1) | PHASE2 | ACTIVE NOT_RECRUITING | 51 | — | — | Apr 21, 2023 | May 16, 2028 | May 6, 2026 | 52 | United States, Georgia +5 |
Proportion of patients with a best overall response of confirmed complete response (CR) or partial response (PR)
| Arm | Type | Description |
|---|---|---|
| Phase 2: Cemiplimab | EXPERIMENTAL | Arm A: Cemiplimab is administered by IV infusion Q3W |
| Phase 2: BNT116 + Cemiplimab | EXPERIMENTAL | Arm B: BNT116 is administered by IV injection. Cemiplimab is administered by IV infusion Q3W. |
| Name | Type | Description |
|---|---|---|
| BNT116 | DRUG | BNT116 is administered by IV injection. |
| Cemiplimab | DRUG | Cemiplimab is administered Q3W by IV infusion |
Key Inclusion Criteria 1. Participants with non-squamous or squamous histology NSCLC with stage IIIB or stage IIIC disease who are not candidates for surgical resection or definitive chemoradiation per investigator assessment or stage IV (metastatic) disease who received no prior systemic treatment...