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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06745908 | Clinical Trial of N-803 Plus Tislelizumab or Prior Failed Immune Checkpoint Inhibitor and Docetaxel Versus Docetaxel Monotherapy in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Acquired Resistance to Immune Checkpoint In | PHASE3 | RECRUITING | 507 | — | — | Oct 1, 2025 | Jan 1, 2029 | May 5, 2026 | 19 | United States |
| Arm | Type | Description |
|---|---|---|
| Cohort A: Experimental Arm | EXPERIMENTAL | 3-week cycles. N803, Tislelizumab, and Docetaxel will be administered on Cycle 1 and 2. N803 and Tislelizumab will be administered on Cycle 3 and onward until end of study. |
| Cohort A: Control Arm | ACTIVE_COMPARATOR | The control arm treatment regimen will consist of repeated 3-week cycles with a ± 3-day window for each visit of Docetaxel 75 mg/m2 IV. |
| Cohort B: Experimental Arm | EXPERIMENTAL | 3-week cycles. N803, prior failed checkpoint inhibitor, and Docetaxel will be administered on Cycle 1 and 2. N803 and prior failed checkpoint inhibitor will be administered on Cycle 3 and onward until end of study. |
| Cohort B: Control Arm | ACTIVE_COMPARATOR | The control arm treatment regimen will consist of repeated 3-week cycles with a ± 3-day window for each visit of Docetaxel 75 mg/m2 IV. |
| Name | Type | Description |
|---|---|---|
| N-803 | DRUG | N-803 1.2 mg SC |
| Tislelizumab | DRUG | Tislelizumab 200 mg IV |
| Docetaxel | DRUG | Docetaxel 75 mg/m2 IV |
| Prior failed checkpoint inhibitor | DRUG | Previously failed checkpoint inhibitor |
Eligibility Criteria: Women and men of all races and ethnic groups are eligible for this trial. Cohort A Inclusion Criteria: 1. Age ≥ 18 years old. 2. Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Commit...