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
Public ClinicalTrials.gov record NCT06745908. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Randomized, Two-Cohort, Open-Label, Phase 3 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT06745908
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 507 participants
Conditions and interventions
Conditions
Interventions
- N-803 Drug
- Tislelizumab Drug
- Docetaxel Drug
- Prior failed checkpoint inhibitor Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 90 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2025
- Primary completion
- Aug 31, 2028
- Completion
- Dec 31, 2028
- Last update posted
- Jul 26, 2026
2025 – 2029
United States locations
- U.S. sites
- 19
- U.S. states
- 11
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Highlands Oncology Group | Springdale | Arkansas | 72762 | Recruiting |
| Chan Soon-Shiong Institute for Medicine | El Segundo | California | 90245 | Recruiting |
| MemorialCare - Orange Coast Medical Center | Fountain Valley | California | 92708 | Recruiting |
| OPN Healthcare INC | Glendale | California | 91203 | Completed |
| OPN Healthcare INC/ Cancer and Blood Specialty Clinic | Los Alamitos | California | 90720 | Completed |
| Holy Cross Hospital | Fort Lauderdale | Florida | 33308 | Recruiting |
| The Oncology Institute of Hope and Innovation | Fort Lauderdale | Florida | 33316 | Recruiting |
| Moffit Cancer Center | Tampa | Florida | 33612-9497 | Recruiting |
| Emory University - Winship Cancer Institute | Atlanta | Georgia | 30322 | Recruiting |
| Barnes-Jewish Hospital - Siteman Cancer Center (Washington University - St. Louis) | St Louis | Missouri | 63110 | Recruiting |
| Carolina Oncology Specialists | Hickory | North Carolina | 28602 | Recruiting |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45267 | Recruiting |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | Recruiting |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | Recruiting |
| Tennessee Oncology | Nashville | Tennessee | 37203 | Recruiting |
| Vanderbilt - Ingram Cancer Center | Nashville | Tennessee | 37232 | Recruiting |
| Virginia Cancer Specialists | Fairfax | Virginia | 22031 | Recruiting |
| Virginia Commonwealth University | Richmond | Virginia | 23219 | Recruiting |
| Medical Oncology Associates - Summit Cancer Centers | Spokane | Washington | 99208 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 17 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06745908, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 26, 2026 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06745908 live on ClinicalTrials.gov.