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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04303780 | Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200). | PHASE3 | ACTIVE NOT_RECRUITING | 345 | — | — | Jun 4, 2020 | Jun 24, 2026 | Apr 30, 2026 | 274 | United States, Australia +21 |
PFS was defined as the time from randomization (baseline) until disease progression or death from any cause, whichever occurred first for all participants. Progression was based on blinded independent central review (BICR) of disease response per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). As pre-specified in the statistical analysis plan, for participants who crossed over from docetaxel to AMG 510, the participant's response post first progression or post crossover was not used for the primary analyses. Data are presented per original treatment randomized.
| Arm | Type | Description |
|---|---|---|
| AMG 510 | EXPERIMENTAL | - |
| Docetaxel | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| AMG 510 | DRUG | 21 day cycles |
| Docetaxel | DRUG | 21 day cycles |
Inclusion Criteria: * Men or women greater than or equal to 18 years old. * ECOG ≤ 1 * Pathologically documented, previously treated, locally-advanced and unresectable or metastatic NSCLC with KRAS p.G12C mutation confirmed through central testing or have documentation of KRAS p.G12C mutation throu...