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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05054725 | Combination Study of RMC-4630 and Sotorasib for NSCLC Subjects With KRASG12C Mutation After Failure of Prior Standard Therapies | PHASE2 | COMPLETED | 47 | — | — | Dec 30, 2021 | Aug 29, 2024 | Jan 6, 2026 | 60 | United States, Australia +8 |
Evaluation of the antitumor effects of RMC-4630 and sotorasib in locally advanced or metastatic NSCLC patients with KRASG12C mutation with and without co-existing genetic aberrations in specific genes such as STK11/LKB1, KEAP1, and PIK3CA after failure of prior standard therapy. Objective Response Rate (%) is defined as the proportion of patients with Best Overall Response of confirmed CR, or PR. Response was confirmed by a repeat assessment no less than 28 days.
| Arm | Type | Description |
|---|---|---|
| RMC-4630 and sotorasib, Safety Run-in | EXPERIMENTAL | Safety Run-In: RMC-4630 and sotorasib |
| RMC-4630 and sotorasib, Expansion | EXPERIMENTAL | Dose Expansion: RMC-4630 and sotorasib |
| Name | Type | Description |
|---|---|---|
| RMC-4630 | DRUG | RMC-4630 administered orally as a capsule |
| Sotorasib | DRUG | Sotorasib administered orally as a tablet |
Inclusion Criteria: * Subject must be ≥18 years of age. * Subject must have pathologically documented, locally advanced or metastatic KRASG12C NSCLC (not amenable to curative surgery) that has progressed on prior standard therapies (no more than 3 prior lines of therapies are allowed) Exclusion Cr...