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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07524257 | Phase 3 Study of Nogapendekin Alfa Inbakicept Plus Standard of Care vs Standard of Care in First-Line Advanced or Metastatic NSCLC | PHASE3 | NOT YET_RECRUITING | 494 | — | — | May 29, 2026 | Dec 30, 2029 | May 4, 2026 | - | — |
PFS is defined as the time from randomization to the first documentation of disease progression per RECIST v1.1 by blinded independent central review (BICR) or death from any cause, whichever occurs first.
| Arm | Type | Description |
|---|---|---|
| Experimental: NAI + Pembrolizumab + Chemotherapy | EXPERIMENTAL | First-line stage IV NSCLC; induction (≤4 cycles) with pembrolizumab + platinum + nab-paclitaxel (squamous) or pemetrexed (nonsquamous) plus NAI, followed by maintenance pembrolizumab ± pemetrexed plus NAI. |
| Active Comparator: Pembrolizumab + Chemotherapy | ACTIVE_COMPARATOR | First-line standard-of-care chemoimmunotherapy per pembrolizumab + platinum doublet regimens, histology-specific. |
| Name | Type | Description |
|---|---|---|
| Drug: Nogapendekin alfa inbakicept (NAI) | DRUG | 1.2 mg SC q3 weeks (15 μg/kg SC if ≥100 kg), up to 35 cycles. |
| Pembrolizumab | DRUG | 200 mg IV q3 weeks. |
| Cisplatin or Carboplatin | DRUG | Cisplatin 75 mg/m² IV q3w OR carboplatin AUC 5-6 IV q3w (per label). |
| Nab-paclitaxel (squamous) OR Pemetrexed (nonsquamous) | DRUG | Squamous: nab-paclitaxel 100 mg/m² IV on Days 1, 8, 15 of cycles 1-4. Nonsquamous: pemetrexed 500 mg/m² IV Day 1 q3w, up to 35 cycles. |
| Nab-paclitaxel OR Paclitaxel OR Docetaxel (squamous) | DRUG | Nab-paclitaxel 100 mg/m² IV D1, 8, 15 or paclitaxel 175 mg/m² IV D1 or docetaxel 75 mg/m² IV D1 (per RHA label/local guidelines) for cycles 1-4 in squamous participants. |
| Pemetrexed (nonsquamous) | DRUG | First-line standard-of-care chemoimmunotherapy per pembrolizumab + platinum doublet regimens, histology-specific. |
Inclusion Criteria: * Age ≥18 years. * Pathologically confirmed stage IV NSCLC (squamous or nonsquamous). * No prior systemic chemotherapy for advanced/metastatic NSCLC. * Tumor lacks an actionable genomic alteration with approved first-line targeted therapy (EGFR, ALK etc.; AGA status from local o...