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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05014815 | Ociperlimab With Tislelizumab and Chemotherapy in Participants With Untreated Metastatic Non-Small Cell Lung Cancer | PHASE2 | COMPLETED | 272 | — | — | Nov 16, 2021 | Sep 4, 2024 | Sep 16, 2025 | 64 | United States, Australia +6 |
PFS was defined as the time from randomization to the first objectively documented disease progression as assessed by the investigator per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) or death from any cause, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method.
| Arm | Type | Description |
|---|---|---|
| Arm A (O+T+C) | EXPERIMENTAL | During the induction phase, participants received ociperlimab (O) 900 mg IV, tislelizumab (T) 200 mg IV, and histology-based chemotherapy (C) every 21 days for 4-6 cycles. For squamous NSCLC, chemotherapy included carboplatin AUC 5 or 6 (on Day 1) + paclitaxel 175 or 200 mg/m² (Day 1) or nab-paclitaxel 100 mg/m² (Days 1, 8, 15) every 3 weeks. For non-squamous NSCLC, chemotherapy included cisplatin 75 mg/m² or carboplatin AUC 5 (Day 1) + pemetrexed (P) 500 mg/m² IV (Day 1), every 3 weeks. In the maintenance phase, non-squamous NSCLC participants received O 900 mg IV, T 200 mg IV, and pemetrexed 500 mg/m² IV every 3 weeks. Squamous NSCLC participants received O 900 mg IV and T 200 mg IV every 3 weeks until toxicity, consent withdrawal, or investigator-determined lack of benefit. |
| Arm B (P+T+C) | PLACEBO_COMPARATOR | During the induction phase, participants received placebo (P) 900 mg IV, tislelizumab (T) 200 mg IV, and histology-based chemotherapy (C) every 21 days for 4-6 cycles. For squamous NSCLC, chemotherapy included carboplatin AUC 5 or 6 (Day 1) + paclitaxel 175 or 200 mg/m² (Day 1) or nab-paclitaxel 100 mg/m² (Days 1, 8, 15) every 3 weeks. For non-squamous NSCLC, chemotherapy included cisplatin 75 mg/m² or carboplatin AUC 5 (Day 1) + pemetrexed (P) 500 mg/m² IV (Day 1), every 3 weeks. In the maintenance phase, non-squamous NSCLC participants received placebo 900 mg IV, T 200 mg IV, and pemetrexed 500 mg/m² IV every 3 weeks. Squamous NSCLC participants received placebo IV and T 200 mg IV every 3 weeks until toxicity, consent withdrawal, or investigator-determined lack of benefit. |
| Name | Type | Description |
|---|---|---|
| Ociperlimab | DRUG | 900 mg intravenously (IV) once every 3 weeks (Q3W) |
| Tislelizumab | DRUG | 200 mg IV Q3W |
| Carboplatin | DRUG | Area under the concentration-time curve (AUC) of 5 or 6, administered on Day 1 of each 21-day cycle |
| Paclitaxel | DRUG | 75 or 200 mg per square meter (mg/m²) of body surface area, administered on Day 1 of each 21-day cycle |
| Nab paclitaxel | DRUG | 100 mg/m², administered intravenously on Days 1, 8, and 15 of each 21-day cycle |
| Cisplatin | DRUG | 75 mg/m², administered intravenously on Day 1 of each 21-day cycle |
| Pemetrexed | DRUG | 500 mg/m² administered intravenously on Day 1 of each 21-day cycle |
| Placebo | DRUG | Administered intravenously Q3W to match ociperlimab |
Key Inclusion Criteria: 1. Participants had histologically or cytologically confirmed locally advanced or recurrent non-small cell lung cancer (NSCLC) that was not eligible for curative surgical resection and/or definitive radiotherapy, with or without chemotherapy. Alternatively, participants had ...