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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04205812 | Platinum-Based Chemotherapy With/Without INCMGA00012, an Anti-PD-1 Antibody, in Non-Small Cell Lung Cancer | PHASE3 | ACTIVE NOT_RECRUITING | 583 | — | — | Sep 11, 2020 | Aug 28, 2026 | Mar 31, 2026 | 140 | United States, Brazil +15 |
Overall survival was defined as the time between the date of randomization and the date of death due to any cause.
| Arm | Type | Description |
|---|---|---|
| INCMGA00012 + chemotherapy (nonsquamous NSCLC) | EXPERIMENTAL | INCMGA00012 with pemetrexed + cisplatin OR carboplatin followed by INCMGA00012 plus pemetrexed until progression. |
| Placebo + chemotherapy (nonsquamous NSCLC) | ACTIVE_COMPARATOR | Placebo with pemetrexed + cisplatin OR carboplatin followed by placebo plus pemetrexed until progression. Participants assigned to placebo + chemotherapy will have the option of receiving open-label monotherapy INCMGA00012 in a crossover period after documentation of progressive disease. |
| INCMGA00012 + chemotherapy (squamous NSCLC) | EXPERIMENTAL | INCMGA00012 with carboplatin + paclitaxel OR nab-paclitaxel followed by INCMGA00012 until progression. |
| Placebo + chemotherapy (squamous NSCLC) | ACTIVE_COMPARATOR | Placebo with carboplatin + paclitaxel OR nab-paclitaxel followed by placebo until progression. Participants assigned to placebo + chemotherapy will have the option of receiving open-label monotherapy INCMGA00012 in a crossover period after documentation of progressive disease. |
| Name | Type | Description |
|---|---|---|
| Retifanlimab | DRUG | INCMGA00012 administered intravenously every 3 weeks on Day 1 of each cycle for up to 35 cycles. |
| Placebo | DRUG | Placebo administered intravenously every 3 weeks on Day 1 of each cycle for up to 35 cycles. |
| Pemetrexed | DRUG | Pemetrexed administered intravenously every 3 weeks on Day 1 of each cycle. |
| Cisplatin | DRUG | Cisplatin administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles. |
| Carboplatin | DRUG | Carboplatin administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles. |
| Paclitaxel | DRUG | Paclitaxel administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles. |
| nab-Paclitaxel | DRUG | nab-Paclitaxel administered intravenously every 3 weeks on Days 1, 8, and 15 of each cycle for 4 cycles. |
Inclusion Criteria: * Histologically or cytologically confirmed NSCLC (either nonsquamous or squamous) that is Stage IV (AJCC v8). * No prior systemic treatment for the advanced/metastatic NSCLC * Able to provide a formalin-fixed archival tumor tissue sample during screening, or a fresh tumor biops...