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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02944396 | Study of Veliparib in Combination With Nivolumab and Platinum Doublet Chemotherapy in Participants With Metastatic or Advanced Non-Small Cell Lung Cancer (NSCLC) | PHASE1 | COMPLETED | 25 | — | — | Dec 23, 2016 | Oct 2, 2019 | Oct 23, 2019 | 6 | United States |
PFS is defined as the number of days from the date of randomization to the date of earliest disease progression (radiographic progression per RECIST version 1.1 or clinical disease progression) or death. If the participant does not experience disease progression or death, then the data will be censored at the date of the last disease assessment.
| Arm | Type | Description |
|---|---|---|
| Veliparib and nivolumab with platinum doublet chemotherapy | EXPERIMENTAL | Veliparib and nivolumab in combination with platinum doublet chemotherapy (carboplatin/paclitaxel or carboplatin/pemetrexed) |
| Veliparib with platinum doublet chemotherapy | EXPERIMENTAL | Veliparib in combination with platinum doublet chemotherapy (carboplatin/paclitaxel or carboplatin/pemetrexed) |
| Name | Type | Description |
|---|---|---|
| pemetrexed | DRUG | intravenous; administered on Day 1 via infusion in a 21-day cycle |
| nivolumab | DRUG | intravenous; administered on Day 1 via infusion in a 21-day cycle |
| paclitaxel | DRUG | intravenous; administered on Day 1 via infusion in a 21-day cycle |
| veliparib | DRUG | oral capsule; varying doses administered on Days -2 to 5 in a 21-day cycle |
| carboplatin | DRUG | intravenous; administered on Day 1 via infusion in a 21-day cycle |
Inclusion Criteria: * Participant must have a life expectancy greater than 12 weeks, * Participant must have cytologically or histologically confirmed Non-small Cell Lung Cancer (NSCLC). * Participant must have metastatic or advanced NSCLC (Stage IIIB or IV) that is not amenable to surgical resecti...