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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06890598 | Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer | PHASE3 | RECRUITING | 700 | — | — | Mar 27, 2025 | Feb 1, 2032 | Jun 3, 2026 | 361 | United States, Australia +27 |
DFS by Investigator Assessment
PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent central review (BICR)
| Arm | Type | Description |
|---|---|---|
| Part A: Olomorasib + Pembrolizumab | EXPERIMENTAL | Participants will receive olomorasib administered orally in combination with pembrolizumab intravenously (IV) for up to 1 year followed by olomorasib alone for up to 3 years of total treatment. |
| Part A: Placebo + Pembrolizumab | PLACEBO_COMPARATOR | Participants will receive placebo administered orally in combination with pembrolizumab administered IV for up to 1 year followed by placebo alone for up to 3 years of total treatment. |
| Part B: Olomorasib + Durvalumab | EXPERIMENTAL | Participants will receive olomorasib administered orally in combination with durvalumab administered IV for up to 1 year followed by olomorasib alone for up to 3 years of total treatment. |
| Part B: Placebo + Durvalumab | PLACEBO_COMPARATOR | Participants will receive placebo administered orally in combination with durvalumab administered IV for up to 1 year followed by placebo alone for up to 3 years of total treatment. |
| Name | Type | Description |
|---|---|---|
| Olomorasib | DRUG | Administered orally. |
| Pembrolizumab | DRUG | Administered intravenously (IV). |
| Durvalumab | DRUG | Administered IV. |
| Placebo | DRUG | Administered orally. |
Inclusion Criteria: * Histological or cytological confirmation of NSCLC. * Part A 1. Clinical Stage II-IIIB (N2) treated with presurgical chemoimmunotherapy, with residual tumor present at time of surgery. Patients with a pathologic complete response are not eligible. 2. Pathologic Stag...