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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06396065 | Phase III Study of AK112 for NSCLC Patients | PHASE3 | ACTIVE NOT_RECRUITING | 420 | — | — | May 4, 2023 | Dec 31, 2026 | Mar 24, 2026 | 74 | United States, Canada +4 |
Progression-free survival (PFS) assessed by IRC per RECIST v1.1 in the ITT population.
| Arm | Type | Description |
|---|---|---|
| AK112 in combination with Pemetrexed and Carboplatin | EXPERIMENTAL | Subjects will receive AK112 Plus Pemetrexed and Carboplatin via intravenous infusion (IV) Q3W, up to 4 cycles. Afterward, AK112 Plus Pemetrexed will be used for maintenance treatment (administered on Day 1 of each cycle, Q3W) up to 2 years. |
| Placebo in combination with Pemetrexed and Carboplatin | ACTIVE_COMPARATOR | Subjects will receive Placebo Plus Pemetrexed and Carboplatin via intravenous infusion (IV) Q3W, up to 4 cycles in treatment periods per the randomization schedule. Afterward, Placebo Plus Pemetrexed will be used for maintenance treatment (administered on Day 1 of each cycle, Q3W) up to 2 years. |
| Name | Type | Description |
|---|---|---|
| AK112 Injection | DRUG | Subjects will receive AK112 Plus Pemetrexed and Carboplatin via intravenous infusion (IV) Q3W, up to 4 cycles. Afterward, AK112 Plus Pemetrexed will be used for maintenance treatment (administered on Day 1 of each cycle, Q3W) up to 2 years. |
| Placebo Injection | DRUG | Subjects will receive Placebo Plus Pemetrexed and Carboplatin via intravenous infusion (IV) Q3W, up to 4 cycles in treatment periods per the randomization schedule. Afterward, Placebo Plus Pemetrexed will be used for maintenance treatment (administered on Day 1 of each cycle, Q3W) up to 2 years. |
Inclusion Criteria: 1. Ability to understand and voluntarily sign a written informed consent form (ICF), which must be signed before the specified study procedures required for the study are performed. 2. Males or females aged ≥ 18 to ≤ 75 years at the time of signing informed consent. (For patient...