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 (NCT06745908)
Randomized, Two-Cohort, Open-Label, 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
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: Review the eligibility criteria below.
Location: Highlands Oncology Group — Springdale, Arkansas
Age range: 18 Years to 90 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (36 Sites)
Showing the first 25 of 36 sites.
- Highlands Oncology Group — Springdale, Arkansas
- Chan Soon-Shiong Institute for Medicine — El Segundo, California
- MemorialCare - Orange Coast Medical Center — Fountain Valley, California
- OPN Healthcare INC — Glendale, California
- OPN Healthcare INC/ Cancer and Blood Specialty Clinic — Los Alamitos, California
- Holy Cross Hospital — Fort Lauderdale, Florida
- The Oncology Institute of Hope and Innovation — Fort Lauderdale, Florida
- Moffit Cancer Center — Tampa, Florida
- Emory University - Winship Cancer Institute — Atlanta, Georgia
- Barnes-Jewish Hospital - Siteman Cancer Center (Washington University - St. Louis) — St Louis, Missouri
- Carolina Oncology Specialists — Hickory, North Carolina
- University of Cincinnati Medical Center — Cincinnati, Ohio
- University Hospitals Cleveland Medical Center — Cleveland, Ohio
- Medical University of South Carolina — Charleston, South Carolina
- Tennessee Oncology — Nashville, Tennessee
- Vanderbilt - Ingram Cancer Center — Nashville, Tennessee
- Virginia Cancer Specialists — Fairfax, Virginia
- Virginia Commonwealth University — Richmond, Virginia
- Medical Oncology Associates - Summit Cancer Centers — Spokane, Washington
- Vancouver Coastal Health — North Vancouver, British Columbia
- Horizon Health Network - Saint John Regional Hospital (SJRH) — Saint John, New Brunswick
- William Osler Health System - Brampton Civic Hospital — Brampton, Ontario
- Waterloo Regional Health Network - Midtown — Kitchener, Ontario
- London Health Sciences Centre - Verspeeten Family Cancer Centre — London, Ontario
- Southlake Regional Health Centre — Newmarket, Ontario
📞 Contact the Study Coordinator
Phone: (856) 739-5609
Email: Phillip.Trieu@immunitybio.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.