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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04685135 | Phase 3 Study of MRTX849 (Adagrasib) vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation | PHASE3 | ACTIVE NOT_RECRUITING | 453 | — | — | Feb 23, 2021 | Jul 2, 2026 | Jan 22, 2025 | 343 | United States, Australia +21 |
Progression-free survival (PFS) is defined as the time from randomization to the date of progression or death due to any cause, whichever occurs first. 95% CI was obtained using Brookmeyer and Crowley method. Participants who are not observed to have progressed or died are censored at the date of last evaluable tumor assessment. Disease progression assessed as per RECISIST 1.1 was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
| Arm | Type | Description |
|---|---|---|
| MRTX849 | EXPERIMENTAL | - |
| Docetaxel | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| MRTX849 | DRUG | 21 day cycles |
| Docetaxel | DRUG | 21 day cycles |
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of NSCLC with KRAS G12C mutation. * Candidacy to receive treatment with docetaxel. Crossover Inclusion Criteria: * Evidence of RECIST 1.1 defined disease progression on docetaxel per BICR * ECOG performance status 0-2 Excl...