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Study identifier: NCT06745908 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: NSCLC Stage IV  ·  Sponsor: ImmunityBio, Inc.

PhasePhase 3
Planned participants507
Who can joinAll sexes, 18 Years to 90 Years
Healthy volunteersNo

About this study

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).

This description comes directly from the study's public registry record.

Talk to the study team

Phillip Trieu  ·  856-739-5609  ·  Phillip.Trieu@immunitybio.com

Tamra Madenwald  ·  Tamra.Madenwald@immunitybio.com

Always discuss trial participation with your own doctor first.

Locations (36)

Highlands Oncology GroupSpringdale, Arkansas, United StatesRecruiting
Chan Soon-Shiong Institute for MedicineEl Segundo, California, United StatesRecruiting
MemorialCare - Orange Coast Medical CenterFountain Valley, California, United StatesRecruiting
OPN Healthcare INCGlendale, California, United StatesCompleted
OPN Healthcare INC/ Cancer and Blood Specialty ClinicLos Alamitos, California, United StatesCompleted
Holy Cross HospitalFort Lauderdale, Florida, United StatesRecruiting
The Oncology Institute of Hope and InnovationFort Lauderdale, Florida, United StatesRecruiting
Moffit Cancer CenterTampa, Florida, United StatesRecruiting
Emory University - Winship Cancer InstituteAtlanta, Georgia, United StatesRecruiting
Barnes-Jewish Hospital - Siteman Cancer Center (Washington University - St. Louis)St Louis, Missouri, United StatesRecruiting
Carolina Oncology SpecialistsHickory, North Carolina, United StatesRecruiting
University of Cincinnati Medical CenterCincinnati, Ohio, United StatesRecruiting

+ 24 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06745908