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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07619339 | A Study of Tepotinib and Ivonescimab in People With Non-Small Cell Lung Cancer | PHASE1 | RECRUITING | 16 | — | — | May 27, 2026 | May 1, 2029 | Jun 2, 2026 | 7 | United States |
The primary objective of the dose finding phase is determination of the recommended dose expansion dose using a standard 3+3 design based on dose-limiting toxicities (DLT). DLT definition: any grade ≥ 3 immune-related adverse event attributable to synergistic combinatorial toxicity from tepotinib and ivonescimab.
| Arm | Type | Description |
|---|---|---|
| Tepotinib and Ivonescimab | EXPERIMENTAL | The study is divided into an initial dose finding phase and subsequent dose expansion phase. A total of 16 patients will be enrolled across these two phases. The sample size for this study was not based on formal power calculations for efficacy, instead focusing on the qualitative description of safety for the combination of tepotinib + ivonescimab. |
| Name | Type | Description |
|---|---|---|
| Tepotinib | DRUG | Tepotinib will be administered at 225mg or 450mg oral daily continuously in every 3 week cycles. |
| Ivonescimab | DRUG | Ivonescimab is administered IV Q3W on Day 1 of each cycle. The total duration of ivonescimab treatment is up to 24 months. |
Criteria: * Documentation of Disease * Patients must have pathologically confirmed non-small cell lung cancer. This includes, but is not limited, to histologies such as adenocarcinoma, squamous cell carcinoma, sarcomatoid carcinoma, and poorly differentiated carcinoma. * Patients must have doc...