RecruitingPhase 3NCT06745908

Clinical Trial of N-803 Plus Tislelizumab or Prior Failed Immune Checkpoint Inhibitor and Docetaxel Versus Docetaxel Monotherapy in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Acquired Resistance to Immune Checkpoint In

ResQ201A-NSCLC: Phase 3 Clinical Trial of N-803 Plus Tislelizumab or Prior Failed Immune Checkpoint Inhibitor 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

Sponsor

ImmunityBio, Inc.

Enrollment

507 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

NSCLC Stage IV

Summary

This is a randomized, two-cohort, open-label, phase 3, clinical trial to compare the efficacy and safety of N-803 plus tislelizumab and docetaxel (cohort A) or prior failed Health Authority-approved antiprogrammed death-1 (PD-1) or anti-programmed death-ligand 1 (PD-L1) CPI and docetaxel (cohort B) versus docetaxel monotherapy (cohorts A and B). For each cohort, enrolled participants will be randomized 2:1 to treatment in the experimental arm or the control arm. For cohort A, the 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 \[ALK\]/ROS proto-oncogene 1, receptor tyrosine kinase \[ROS1\] vs Other AGA vs No AGA). For cohort B, the randomization will be stratified by geographical region (Americas vs Asia Pacific \[PAC\] vs Other), NSCLC histology (squamous vs nonsquamous), and actionable genomic alteration (AGA) (Yes vs No).

Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study (ResQ201A) tests whether combining N-803 (an immune-boosting drug) and tislelizumab (an immunotherapy drug) with docetaxel (standard chemotherapy) works better than docetaxel alone for people with advanced non-small cell lung cancer (NSCLC) whose cancer progressed after responding to immunotherapy. **You may be eligible if...** - You are 18 or older - You have confirmed Stage IV NSCLC - Your cancer initially responded to immunotherapy (PD-L1 or CTLA-4 inhibitor) but then progressed - You are in reasonably good physical condition (ECOG 0–2) - You have measurable disease on imaging - Your blood counts, liver, and kidney function are adequate **You may NOT be eligible if...** - You have an ALK gene rearrangement - You have active autoimmune disease currently requiring treatment - You have had organ transplant or received immunosuppressive therapy recently - You have active hepatitis B or C, or active infection requiring antibiotics - You have had a prior severe allergic reaction to docetaxel - You are pregnant or breastfeeding - You have a history of severe reaction to prior immunotherapy requiring its permanent discontinuation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGN-803

N-803 1.2 mg SC

DRUGTislelizumab

Tislelizumab 200 mg IV

DRUGDocetaxel

Docetaxel 75 mg/m2 IV

DRUGPrior failed checkpoint inhibitor

Previously failed checkpoint inhibitor

Locations(19)

Highlands Oncology Group

Springdale, Arkansas, United States

Chan Soon-Shiong Institute for Medicine

El Segundo, California, United States

MemorialCare - Orange Coast Medical Center

Fountain Valley, California, United States

OPN Healthcare INC

Glendale, California, United States

OPN Healthcare INC/ Cancer and Blood Specialty Clinic

Los Alamitos, California, United States

Holy Cross Hospital

Fort Lauderdale, Florida, United States

The Oncology Institute of Hope and Innovation

Fort Lauderdale, Florida, United States

Moffit Cancer Center

Tampa, Florida, United States

Emory University - Winship Cancer Institute

Atlanta, Georgia, United States

Barnes-Jewish Hospital - Siteman Cancer Center (Washington University - St. Louis)

St Louis, Missouri, United States

Carolina Oncology Specialists

Hickory, North Carolina, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Tennessee Oncology

Nashville, Tennessee, United States

Vanderbilt - Ingram Cancer Center

Nashville, Tennessee, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Medical Oncology Associates - Summit Cancer Centers

Spokane, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT06745908

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