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NCT07524257

PHASE3

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.

View on ClinicalTrials.gov

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.

Official title: Phase 3, Randomized, Open-Label Study of Nogapendekin Alfa Inbakicept in Combination With Standard of Care Versus Standard of Care as First-Line Treatment for Patients With Advanced or Metastatic Non-Small Cell Lung Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-05-29

Completion Date

2029-12-30

Last Updated

2026-06-22

Healthy Volunteers

Conditions

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

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.

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 or central testing; ctDNA acceptable if tissue unavailable). * PD L1 result available before randomization: TPS ≥1%, \<1%, or unknown. * ECOG performance status 0-1. * At least one measurable lesion per RECIST v1.1. * Able to attend visits and follow-up. * Contraception requirements for women of childbearing potential and nonsterile males, with 7 month post-last-dose window. Exclusion Criteria: * Body weight \<40 kg. * Serious uncontrolled concomitant disease. * Certain prior malignancies (exceptions: adequately treated or nonmetastatic, as per protocol). * Active autoimmune disease requiring systemic treatment (exceptions: autoimmune thyroiditis, etc.). * Prior organ transplant requiring immunosuppression. * Prior pneumonitis/interstitial lung disease requiring active systemic treatment. * Prior systemic chemotherapy or immunotherapy within 3 years. * Requirement for other anticancer therapy while on study (palliative RT allowed). * Known CNS metastases, carcinomatous meningitis, and/or spinal cord compression (with specified exceptions for treated or asymptomatic brain mets). * HIV infection or active/uncontrolled HBV/HCV not meeting the protocol's controlled criteria. * Active infection requiring IV therapy. * Inadequate organ function: * ANC \<1,500/mm³; platelets \<100,000/mm³; Hgb \<9 g/dL. * Total bilirubin \>1.5×ULN (with defined Gilbert's exception). * AST/ALT \>1.5×ULN (or \>5×ULN with liver mets). * ALP \>2.5×ULN (or \>5×ULN with bone mets). * Creatinine clearance \<40 mL/min (Cockcroft-Gault). * Significant cardiovascular disease (uncontrolled HTN, recent MI, stroke, CHF ≥NYHA II, serious arrhythmia). * Known hypersensitivity to study drugs. * Concomitant medications known to interact adversely with study drugs. * Participation in another investigational drug/device study (except hormone-lowering therapy). * Pregnancy or breastfeeding. * Confinement by court order/authority. * Any condition or noncompliance that, in Investigator judgment, precludes participation.

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria