Phase 3 Study of Nogapendekin Alfa Inbakicept Plus Standard of Care vs Standard of Care in First-Line Advanced or Metastatic NSCLC

Sponsor
ImmunityBio, Inc.
Study ID
NCT07524257
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Metastatic NSCLC
  • NSCLC (Advanced Non-small Cell Lung Cancer)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

This is a randomized, open-label, phase 3 study evaluating nogapendekin alfa inbakicept (NAI) plus chemoimmunotherapy containing pembrolizumab and platinum-based chemotherapy versus chemoimmunotherapy alone as first-line treatment in patients with stage IV squamous or nonsquamous non-small cell lung cancer (NSCLC) without actionable genomic alterations. Primary endpoint is progression-free survival by RECIST v1.1 based on blinded independent central review.

Key Dates

Start date
May 29, 2026
Status verified
Apr 2026
Primary completion
May 15, 2029
Completion
Dec 30, 2029

Study Design

Enrollment
494 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: NAI + Pembrolizumab + Chemotherapy
    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: Active Comparator: Pembrolizumab + Chemotherapy
    First-line standard-of-care chemoimmunotherapy per pembrolizumab + platinum doublet regimens, histology-specific.

Primary Outcome Measure

Progression-Free Survival (PFS) by BICR (RECIST v1.1) [ Time Frame: Imaging every 9 weeks (±7 days) from first dose (after initial assessments at week 6 and week 12) until treatment discontinuation; final PFS analysis with follow-up through 156 weeks (3 years) from first dose. ]

Central Contacts

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