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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05502237 | Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer | PHASE3 | ACTIVE NOT_RECRUITING | 1,021 | — | — | Oct 12, 2022 | Jan 1, 2029 | Jan 30, 2026 | 186 | United States, Argentina +21 |
OS is defined as the time from the date of randomization to the date of death from any cause.
| Arm | Type | Description |
|---|---|---|
| Zimberelimab (ZIM) +Domvanalimab (DOM) + Chemotherapy | EXPERIMENTAL | Participants will receive ZIM 360 mg + DOM 1200 mg (up to 35 doses) with chemotherapy every 3 weeks (Q3W) on Day 1 of each 21-day cycle. Choice of chemotherapy is dependent on histology. * Participants with nonsquamous histology will receive cisplatin 75 mg/m\^2 or carboplatin area under the concentration versus time curve (AUC)5 + pemetrexed 500 mg/m\^2 Q3W for first 4 cycles. After the completion of the first 4 cycles, participants with nonsquamous histology may continue with maintenance pemetrexed 500 mg/m\^2 Q3W until disease progression or intolerable toxicities. * Participants with squamous histology will receive carboplatin AUC 6 Q3W with paclitaxel 200 mg/m\^2 Q3W or nab-paclitaxel 100 mg/m\^2 weekly (QW) for first 4 cycles. |
| Pembrolizumab (PEMBRO) + Chemotherapy | ACTIVE_COMPARATOR | Participants will receive PEMBRO 200 mg (up to 35 doses) with chemotherapy Q3W on Day 1 of each 21-day cycle. Choice of chemotherapy is dependent on histology. * Participants with nonsquamous histology will receive cisplatin 75 mg/m\^2 or carboplatin AUC 5 + pemetrexed 500 mg/m\^2 Q3W for first 4 cycles. After the completion of the first 4 cycles, participants with nonsquamous histology may continue with maintenance pemetrexed 500 mg/m\^2 Q3W until disease progression or intolerable toxicities. * Participants with squamous histology will receive carboplatin AUC 6 Q3W with paclitaxel 200 mg/m\^2 Q3W or nab-paclitaxel 100 mg/m\^2 weekly (QW) for first 4 cycles. |
| Zimberelimab (ZIM) + Chemotherapy | EXPERIMENTAL | Participants will receive ZIM 360 mg (up to 35 doses) with chemotherapy Q3W on Day 1 of each 21-day cycle. Choice of chemotherapy is dependent on histology. * Participants with nonsquamous histology will receive cisplatin 75 mg/m\^2 or carboplatin AUC 5 + pemetrexed 500 mg/m\^2 Q3W for first 4 cycles After the completion of the first 4 cycles, participants with nonsquamous histology may continue with maintenance pemetrexed 500 mg/m\^2 Q3W until disease progression or intolerable toxicities. * Participants with squamous histology will receive carboplatin AUC 6 Q3W with paclitaxel 200 mg/m\^2 Q3W or nab-paclitaxel 100 mg/m\^2 weekly (QW) for first 4 cycles. |
| Name | Type | Description |
|---|---|---|
| Zimberelimab | DRUG | Administered intravenously |
| Domvanalimab | DRUG | Administered intravenously |
| Pembrolizumab | DRUG | Administered intravenously |
| Carboplatin | DRUG | Administered intravenously |
| Cisplatin | DRUG | Administered intravenously |
| Paclitaxel | DRUG | Administered intravenously |
| Nab-paclitaxel | DRUG | Administered intravenously |
| Pemetrexed | DRUG | Administered intravenously |
Key Inclusion Criteria: * Life expectancy ≥ 3 months. * Pathologically documented NSCLC that meets both of the criteria below: * Have documented evidence of Stage IV NSCLC disease at the time of enrollment (based on American Joint Committee on Cancer (AJCC), Eighth Edition). * Have documented ...