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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

NCT06745908

This study is recruiting at 30 US sites in 15 states, according to its ClinicalTrials.gov record last updated .

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • NSCLC Stage IV

Eligibility basics and study details

Study type
Interventional
Phase
Phase 3
Ages
18 to 90 years
Sex
All
Healthy volunteers
Not accepted
Sponsor
ImmunityBio, Inc.
Last updated on ClinicalTrials.gov
November 2, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

Arkansas · 2

  • Genesis Cancer and Blood Institute · Hot Springs, AR
  • Highlands Oncology Group · Springdale, AR

California · 5

  • Chan Soon-Shiong Institute for Medicine · El Segundo, CA
  • MemorialCare - Orange Coast Medical Center · Fountain Valley, CA
  • Providence Medical Foundation · Fullerton, CA
  • City of Hope · Irvine, CA
  • Hoag Memorial Hospital Presbyterian · Newport Beach, CA

Florida · 6

  • Holy Cross Hospital · Fort Lauderdale, FL
  • The Oncology Institute of Hope and Innovation · Fort Lauderdale, FL
  • Florida Oncology & Hematology · Fort Myers, FL
  • Lee Health · Fort Myers, FL
  • Sylvester Comprehensive Cancer Center at Miami University · Miami, FL
  • Moffit Cancer Center · Tampa, FL

Georgia · 1

  • Emory University - Winship Cancer Institute · Atlanta, GA

Hawaii · 1

  • Hawaii Cancer Care · Honolulu, HI

Indiana · 2

  • Hematology Oncology of Indiana · Indianapolis, IN
  • Baptist Health Floyd · New Albany, IN

Kentucky · 1

  • Baptist Health Louisville · Louisville, KY

Missouri · 2

  • Oncology Hematology Associates · Springfield, MO
  • Barnes-Jewish Hospital - Siteman Cancer Center (Washington University - St. Louis) · St Louis, MO

North Carolina · 1

  • Carolina Oncology Specialists · Hickory, NC

Ohio · 2

  • University of Cincinnati Medical Center · Cincinnati, OH
  • University Hospitals Cleveland Medical Center · Cleveland, OH

South Carolina · 1

  • Medical University of South Carolina · Charleston, SC

Tennessee · 2

  • Tennessee Oncology · Nashville, TN
  • Vanderbilt - Ingram Cancer Center · Nashville, TN

Texas · 1

  • Woodlands Cancer Institute · Shenandoah, TX

Virginia · 2

  • Virginia Cancer Specialists · Fairfax, VA
  • Virginia Commonwealth University · Richmond, VA

Washington · 1

  • Medical Oncology Associates - Summit Cancer Centers · Spokane, WA

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.