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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07355205 | First-Line Ipilimumab Plus Nivolumab and Nogapendekin Alfa Inbakicept (N-803) in Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer | PHASE2 | NOT YET_RECRUITING | 26 | — | — | Jun 30, 2026 | Jun 30, 2032 | May 22, 2026 | 1 | United States |
PFS is defined as the duration of time from the start date of study treatment to the date of earliest progression or death, whichever occurs first. Patients who neither progress nor die by the data cutoff date will be censored at the last follow up date.
| Arm | Type | Description |
|---|---|---|
| Ipilimumab plus Nivolumab and Nogapendekin alfa inbakicept (N-803) | EXPERIMENTAL | Consenting and eligible patients will receive nivolumab intravenously (IV) on Days 1 and 22, ipilimumab IV on Day 1, and nogapendekin alfa inbakicept subcutaneously (SC) on Days 1 and 22 of each cycle for Cycles 1 through 4; ipilimumab will be discontinued after Cycle 4 and patients will continue to receive nivolumab and nogapendekin alfa inbakicept on the same schedule for up to 2 years. Cycles are 42 days (6 weeks). |
| Name | Type | Description |
|---|---|---|
| Ipilimumab | DRUG | Ipilimumab will be given intravenously at a dose of 1mg/kg. |
| Nivolumab | DRUG | Nivolumab will be given intravenously at a dose of 360mg. |
| Nogapendekin alfa inbakicept | DRUG | Nogapendekin alfa inbakicept will be given subcutaneously at a dose of 15 μg/kg. |
Inclusion Criteria: * Histologically or cytologically confirmed, previously untreated or recurrent metastatic NSCLC. * Availability of archival biopsy tissue or willingness to undergo a biopsy prior to C1D1 for biomarker analysis, including PD-L1 by IHC using a CLIA-certified test. Results of the P...