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
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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).
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 18 lat lub więcej
- •Potwierdzona histopatologicznie czwarta faza raka płuc (zaawansowana lub z przerzutami)
- •Uzyskanie oporu na leczenie po uprzedniej odpowiedzi na immunoterapię łączoną z chemioterapią
- •Wcześniejsze leczenie chemioterapią na bazie platyny
- •Bezpośrednio poprzednia terapia musiała zawierać leki anty-PD-1 lub anty-PD-L1
- •U pacjentów z mutacjami genetycznymi - wcześniejsze leczenie lekami celowanymi zgodnie ze standardami
- •Zdolność do zrozumienia i podpisania świadomej zgody na uczestnictwo w badaniu
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 90 Years
- Last updated (source)
- July 27, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (36)
Highlands Oncology Group
Springdale, United States
Chan Soon-Shiong Institute for Medicine
El Segundo, United States
MemorialCare - Orange Coast Medical Center
Fountain Valley, United States
OPN Healthcare INC
Glendale, United States
OPN Healthcare INC/ Cancer and Blood Specialty Clinic
Los Alamitos, United States
Holy Cross Hospital
Fort Lauderdale, United States
The Oncology Institute of Hope and Innovation
Fort Lauderdale, United States
Moffit Cancer Center
Tampa, United States
Emory University - Winship Cancer Institute
Atlanta, United States
Barnes-Jewish Hospital - Siteman Cancer Center (Washington University - St. Louis)
St Louis, United States
Carolina Oncology Specialists
Hickory, United States
University of Cincinnati Medical Center
Cincinnati, United States
University Hospitals Cleveland Medical Center
Cleveland, United States
Medical University of South Carolina
Charleston, United States
Tennessee Oncology
Nashville, United States
Vanderbilt - Ingram Cancer Center
Nashville, United States
Virginia Cancer Specialists
Fairfax, United States
Virginia Commonwealth University
Richmond, United States
Medical Oncology Associates - Summit Cancer Centers
Spokane, United States
Vancouver Coastal Health
North Vancouver, Canada
Horizon Health Network - Saint John Regional Hospital (SJRH)
Saint John, Canada
William Osler Health System - Brampton Civic Hospital
Brampton, Canada
Waterloo Regional Health Network - Midtown
Kitchener, Canada
London Health Sciences Centre - Verspeeten Family Cancer Centre
London, Canada
Southlake Regional Health Centre
Newmarket, Canada
University of Windsor
Windsor, Canada
Belfast Health and Social Care Trust - Belfast City Hospital
Belfast, United Kingdom
Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital
Truro, United Kingdom
Betsi Cadwaladr University Health Board - Glan Clwyd Hospital
Bodelwyddan, United Kingdom
Velindre NHS Trust - Velindre Cancer Centre VCC
Cardiff, United Kingdom
Royal London Hospital
London, United Kingdom
Southampton General Hospital, Southampton University Hospital National Health Service Trust
Southampton, United Kingdom
NRS South-East Cancer Research Network
Edinburgh, United Kingdom
Royal Surrey County Hospital NHS Foundation Trust - St Lukes Cancer Centre
Guildford, United Kingdom
University Hospital Birmingham NHS Trust
Birmingham, United Kingdom
Betsi Cadwaladr University Health Board Wrexham Maelor Hospital
Wrexham, United Kingdom
Trial contact
Phillip Trieu
Tamra Madenwald
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/28/2026.
You can help another person
We fund the Radar, this site, and the development of our Grosz dla Życia fundraising platform from donations and our own resources. Every contribution, even a small one, really helps.