NCT06745908

ResQ201A: Clinical Trial Of N-803 Plus TISLELIZUMAB And DOCETAXEL Versus DOCETAXEL Monotherapy In Participants With Advanced Or Metastatic Non-Small Cell Lung Cancer

ResQ201A: Randomized, Open-Label, Phase 3 Clinical Trial of N-803 Plus Tislelizumab and Docetaxel Versus Docetaxel Monotherapy in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Acquired Resistance to Immune Checkpoint Inhibitor Therapy

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 460 (estimated)
• Sponsor: ImmunityBio, Inc. · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, open-label, phase 3 clinical trial to compare the efficacy and safety of N-803 plus tislelizumab and docetaxel (experimental arm) versus docetaxel monotherapy (control arm). Enrolled participants will be randomized 2:1 to treatment in the experimental arm or the control arm. Participant randomization will be stratified by geographical region (North America vs Europe vs ASIA vs Other), NSCLC histology (squamous vs nonsquamous), and actionable genomic alteration (AGA); (epidermal growth factor receptor \[EGFR\]/anaplastic lymphoma kinase \[ALK\] vs OTHER AGA vs No AGA).

Conditions

• NSCLC Stage IV

Interventions

Type	Name	Description
DRUG	N-803	N-803 1.2 mg SC
DRUG	Tislelizumab	Tislelizumab 200 mg IV
DRUG	Docetaxel	Docetaxel 75 mg/m2 IV

Timeline

• Start date: 2025-10-01
• Primary completion: 2028-09-01
• Completion: 2029-01-01
• First posted: 2024-12-20
• Last updated: 2026-04-15

Locations

19 sites across 1 country: United States

Regulatory

• FDA-regulated drug study