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

NCT07524257 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 494

Last updated 2026-05-04

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Drug: Nogapendekin alfa inbakicept (NAI)

1.2 mg SC q3 weeks (15 μg/kg SC if ≥100 kg), up to 35 cycles.

DRUG

Pembrolizumab

200 mg IV q3 weeks.

DRUG

Cisplatin or Carboplatin

Cisplatin 75 mg/m² IV q3w OR carboplatin AUC 5-6 IV q3w (per label).

DRUG

Nab-paclitaxel (squamous) OR Pemetrexed (nonsquamous)

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.

DRUG

Nab-paclitaxel OR Paclitaxel OR Docetaxel (squamous)

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.

DRUG

Pemetrexed (nonsquamous)

First-line standard-of-care chemoimmunotherapy per pembrolizumab + platinum doublet regimens, histology-specific.

Sponsors & Collaborators

  • ImmunityBio, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-29
Primary Completion
2029-05-15
Completion
2029-12-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07524257 on ClinicalTrials.gov