Clinical trialNCT06745908RecruitingPhase 3Interventional

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

SponsorImmunityBio, Inc.Enrollment507NSCLC Stage IV

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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).

clinicaltrials.gov ↗

Investigators

No overall officials are registered on this study record. Site-level investigators, where published, appear with their sites below. Why? →

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

36 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada

Vancouver Coastal Health
North Vancouver, British Columbia, Canada
Puneet Bains, MD, FRCPC
Recruiting
Horizon Health Network - Saint John Regional Hospital (sjrh)
Saint John, New Brunswick, Canada
James Michael, BSc, MD, MA, FRCPC
Recruiting
William Osler Health System - Brampton Civic Hospital
Brampton, Ontario, Canada
Kristin Perdrizet, MD
Recruiting
Waterloo Regional Health Network - Midtown
Kitchener, Ontario, Canada
Mario Valdes, MD. FRCPC
Recruiting
London Health Sciences Centre - Verspeeten Family Cancer Centre
London, Ontario, Canada
Daniel Breadner, MD. FRCPC, MSc, Bsc
Recruiting
Southlake Regional Health Centre
Newmarket, Ontario, Canada
Shaqil Kassam, MSc, MD, FRCPC
Recruiting
University of Windsor
Windsor, Ontario, Canada
Deepro Chowdhury, B.A., MD, FRCPC
Recruiting

United Kingdom

Belfast Health and Social Care Trust - Belfast City Hospital
Belfast, Antrim, United Kingdom
Lynn Campbell, MB ChB, MRCP
Recruiting
Royal Cornwall Hospitals Nhs Trust - Royal Cornwall Hospital
Truro, Cornwall, United Kingdom
Grant Stewart, MBBS, MRCP, FRCR
Recruiting
Betsi Cadwaladr University Health Board - Glan Clwyd Hospital
Bodelwyddan, Denbighshire, United Kingdom
Angel Garcia, LMS
Recruiting
Velindre Nhs Trust - Velindre Cancer Centre Vcc
Cardiff, Glamorgan, United Kingdom
Paul Shaw, FRCP, FRCR, PhD
Recruiting
Royal London Hospital
London, Greater London, United Kingdom
Ekaterini Boleti, MD, PhD, FRCP
Recruiting
Southampton General Hospital, Southampton University Hospital National Health Service Trust
Southampton, Hampshire, United Kingdom
Judith Cave, MRCP, MD, FRCP
Recruiting
Nrs South-East Cancer Research Network
Edinburgh, Midlothian, United Kingdom
Colin Barrie, MBBS, MRCP
Recruiting
Royal Surrey County Hospital Nhs Foundation Trust - St Lukes Cancer Centre
Guildford, Surrey, United Kingdom
Ajay Mehta, MBBS, MS, FACS
Recruiting
University Hospital Birmingham Nhs Trust
Birmingham, West Midlands, United Kingdom
Shobhit Baijal, MBBS, MRCP
Recruiting
Betsi Cadwaladr University Health Board Wrexham Maelor Hospital
Wrexham, Wrexham, United Kingdom
Simon Gollins, BMBCh DPhil MRCP FRCR
Recruiting

United States

Highlands Oncology Group
Springdale, Arkansas, United States
Eric Schaefer, MD
Recruiting
Chan Soon-Shiong Institute for Medicine
El Segundo, California, United States
Tara Seery, MD
Recruiting
Memorialcare - Orange Coast Medical Center
Fountain Valley, California, United States
Amol Rao
Recruiting
Opn Healthcare Inc
Glendale, California, United States
Completed
Opn Healthcare Inc/ Cancer and Blood Specialty Clinic
Los Alamitos, California, United States
Completed
Holy Cross Hospital
Fort Lauderdale, Florida, United States
Georges Azzi, MD
Recruiting
the Oncology Institute of Hope and Innovation
Fort Lauderdale, Florida, United States
Edward S Santos, MD
Recruiting
Moffit Cancer Center
Tampa, Florida, United States
Andreas Saltos, MD
Recruiting
Emory University - Winship Cancer Institute
Atlanta, Georgia, United States
Jennifer Carlisle, MD
Recruiting
Barnes-Jewish Hospital - Siteman Cancer Center (washington University - St. Louis)
St Louis, Missouri, United States
Daniel Morgensztern →
Recruiting
Carolina Oncology Specialists
Hickory, North Carolina, United States
Justin Favaro, MD
Recruiting
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Kerri McGovern, MD
Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Matthew Mirsky, MD
Recruiting
Medical University of South Carolina
Charleston, South Carolina, United States
Mariam Alexander, MD
Recruiting
Tennessee Oncology
Nashville, Tennessee, United States
Wade Iams, MDD
Recruiting
Vanderbilt - Ingram Cancer Center
Nashville, Tennessee, United States
Shuai Wang, MD
Recruiting
Virginia Cancer Specialists
Fairfax, Virginia, United States
Alexander Spira, MD
Recruiting
Virginia Commonwealth University
Richmond, Virginia, United States
Jonathan Berkman, MD
Recruiting
Medical Oncology Associates - Summit Cancer Centers
Spokane, Washington, United States
Arvind Chaudhry, MD
Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Docetaxel →N-803 →Prior failed checkpoint inhibitor →Tislelizumab →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 1 Oct 2025
Primary completion: 30 Sept 2028
Completion: 31 Jan 2029
Last update posted: 27 Jul 2026
Registered enrollment: 507
Registry id: NCT06745908

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.