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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02152631 | A Study of Abemaciclib (LY2835219) in Participants With Previously Treated KRAS Mutated Lung Cancer | PHASE3 | ACTIVE NOT_RECRUITING | 453 | — | — | Oct 3, 2014 | Dec 1, 2026 | Feb 6, 2026 | 231 | United States, Argentina +19 |
| NCT02779751 | A Study of Abemaciclib (LY2835219) in Participants With Non-Small Cell Lung Cancer or Breast Cancer | PHASE1 | ACTIVE NOT_RECRUITING | 100 | — | — | Nov 14, 2016 | Dec 1, 2026 | Jan 26, 2026 | 24 | United States, Belgium +5 |
OS defined as from randomization date to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.
| Arm | Type | Description |
|---|---|---|
| Abemaciclib | EXPERIMENTAL | 200 milligrams (mg) abemaciclib administered, orally, every 12 hours plus best supportive care (BSC) on Days 1 to 28 (28 day cycles). |
| Erlotinib | ACTIVE_COMPARATOR | 150 mg erlotinib administered, orally, every 24 hours plus BSC on Days 1 to 28 (28 day cycles). |
| NSCLC KRAS mt, PD-L1+ | EXPERIMENTAL | Abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle in combination with pembrolizumab given intravenously (IV) on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met. |
| NSCLC Squamous | EXPERIMENTAL | Abemaciclib given orally Q12H on days 1 to 21 of each 21 day cycle in combination with pembrolizumab given IV on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met. |
| HR+, HER2- Metastatic Breast Cancer | EXPERIMENTAL | Abemaciclib given orally Q12H on days 1 to 21 of each 21 day cycle in combination with pembrolizumab given IV on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met. |
| HR+, HER2- Locally Advanced or Metastatic Breast Cancer | EXPERIMENTAL | Abemaciclib given orally Q12H on days 1 to 21 of each 21 day cycle in combination with pembrolizumab given IV on day 1 of each 21 day cycle and anastrozole given orally Q24H on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met. |
| Name | Type | Description |
|---|---|---|
| Abemaciclib | DRUG | Administered orally |
| Erlotinib | DRUG | Administered orally |
| Pembrolizumab | DRUG | Administered IV |
| Anastrozole | DRUG | Administered orally |
Inclusion Criteria: * Have confirmed diagnosis of stage IV non-small cell lung cancer (NSCLC) according to the American Joint Committee on Cancer Staging Handbook. * Determined to have detectable mutations in codons 12 or 13 of the kirsten rat sarcoma (KRAS) oncogene by an investigational assay at ...