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)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Age ≥ 18 years old.
2. Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
3. Pathologically confirmed stage IV NSCLC disease.
4. Have acquired resistance to a regional Health Authority-approved immune plus platinum-based chemotherapy, defined as disease progression immediately following an initial response (of any duration) or stable disease (approximately 6 months duration \[± 2 weeks\]). Participants who received anti-PD-1/anti-PD-L1 mAb as first-line therapy may have received the combination of platinum-based chemotherapy and anti-PD-1/anti-PD-L1 mAb in the second line. Participants must have received platinum chemotherapy to be eligible. Participants must have received anti-PD-1/anti-PD-L1 mAb in their immediate prior line of therapy to be eligible.
5. Participants with AGA must have 1 or more documented AGA(s): EGFR, ROS1, neurotrophic tyrosine receptor kinase (NTRK), B rapidly accelerated fibrosarcoma (BRAF), mesenchymal epithelial transition (MET) exon 14 skipping, rearranged during transfection (RET), Kirsten Rat sarcoma (KRAS) and HER2.
6. Participants with AGA must meet the following criteria for advanced or metastatic NSCLC. Participants who have been treated with 1 or 2 prior lines of applicable targeted therapy that is locally approved (and is standard of care) for the participant's genomic alteration at the time of screening:
7. Participants who have tumors with EGFR L858R or exon 19 deletion mutations must have received prior osimertinib.
8. Participants who received a targeted agent as adjuvant therapy for early-stage disease must have relapsed or progressed while on the treatment or within 6 months of the last dose or received at least one additional course of targeted therapy for the same genomic alteration (which may or may not be same agent used in the adjuvant setting) for relapsed/progressive disease.
9. Participants who have been treated with a prior tyrosine kinase inhibitor (TKI) must receive additional approved targeted therapy, if locally available and clinically appropriate, for the applicable genomic alteration, or the participant will not be allowed in the study.
10. Participants must also meet the inclusion criteria #4 listed above.
11. ECOG performance status of 0 to 2.
12. Measurable tumor lesions according to RECIST v1.1.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (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

💰 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.