Actively Recruiting
Randomized Phase 3 Trial of N-803 Plus Tislelizumab or Prior Failed Checkpoint Inhibitor and Docetaxel Versus Docetaxel Alone in Advanced or Metastatic Non-Small Cell Lung Cancer Resistant to Checkpoint Inhibitor Therapy
Led by ImmunityBio, Inc. · Updated on 2026-05-05
507
Participants Needed
19
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for adults with advanced or metastatic non-small cell lung cancer (NSCLC) who have developed resistance to immune checkpoint inhibitor therapy. This randomized, open-label phase 3 trial compares the combination of N-803 plus tislelizumab and docetaxel or N-803 plus a prior failed immune checkpoint inhibitor and docetaxel against docetaxel alone. The study aims to compare overall survival between these treatment approaches in two separate participant groups, called cohorts A and B. Participants will be assigned to one of two cohorts based on their prior treatments and genomic alterations. In cohort A, participants receive N-803, tislelizumab, and docetaxel for the first two 3-week cycles, followed by N-803 and tislelizumab alone from cycle 3 onward until the study ends. Cohort B participants receive N-803, the prior failed checkpoint inhibitor, and docetaxel for the first two cycles, then continue with N-803 and the prior failed checkpoint inhibitor alone. Control groups in both cohorts receive docetaxel monotherapy every 3 weeks. Treatment continues in cycles with specific dosing schedules until the study concludes. During the trial, participants will have regular visits every 3 weeks to receive treatments and undergo evaluations. Researchers will monitor tumor response using imaging and measure overall survival approximately 12 months after treatment. Participants must be able to attend all required visits and follow-ups. Safety and response will be closely tracked throughout the study, which is expected to run until early 2029.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 90 years
- Able to provide informed consent
- Pathologically confirmed stage IV NSCLC
- Acquired resistance to immune plus platinum-based chemotherapy
- Received platinum chemotherapy and anti-PD-1/PD-L1 antibody in immediate prior therapy
- For participants with actionable genomic alterations, must meet specified prior targeted therapy requirements
- ECOG performance status of 0 to 2
- Measurable tumor lesions per RECIST v1.1
- Life expectancy of at least 3 months
- Ability to attend study visits and follow-ups
- Agreement to use effective contraception if applicable
- Participants with HIV must be on antiretroviral therapy with undetectable viral load
You will not qualify if you...
- Systemic autoimmune disease requiring treatment or within specified washout period
- History of severe drug-induced skin reactions or immune-mediated reactions
- History of stem cell or organ transplant requiring immunosuppression
- Presence of CNS metastases or spinal cord compression
- Body weight 40 kg or less
- Active infection requiring antibiotics
- Recent live vaccine within 4 weeks prior to study drug
- History of severe hypersensitivity to docetaxel or related drugs
- Major surgery or serious illness within 28 days prior to randomization
- Inadequate organ function based on laboratory tests
- Pregnant or nursing women
- Prior adverse reactions to immunotherapy leading to discontinuation
- Participation in other investigational drug studies within specified timeframes
- Other criteria assessed by investigator affecting protocol compliance or safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to approximately 12 months
Participants receive treatment in repeated 3-week cycles. Experimental arms receive combinations of N-803, Tislelizumab or prior failed checkpoint inhibitor, and Docetaxel in the first two cycles, followed by N-803 with Tislelizumab or prior failed checkpoint inhibitor from Cycle 3 onward. Control arms receive Docetaxel monotherapy every 3 weeks.
3-week cycles with treatments administered on Cycle 1 and 2 and continued treatments on Cycle 3 and onward
Trial Site Locations
Total: 19 locations
1
Highlands Oncology Group
Springdale, Arkansas, United States, 72762
Actively Recruiting
2
Chan Soon-Shiong Institute for Medicine
El Segundo, California, United States, 90245
Actively Recruiting
3
MemorialCare - Orange Coast Medical Center
Fountain Valley, California, United States, 92708
Actively Recruiting
4
OPN Healthcare INC
Glendale, California, United States, 91203
Actively Recruiting
5
OPN Healthcare INC/ Cancer and Blood Specialty Clinic
Los Alamitos, California, United States, 90720
Actively Recruiting
6
Holy Cross Hospital
Fort Lauderdale, Florida, United States, 33308
Actively Recruiting
7
The Oncology Institute of Hope and Innovation
Fort Lauderdale, Florida, United States, 33316
Actively Recruiting
8
Moffit Cancer Center
Tampa, Florida, United States, 33612-9497
Actively Recruiting
9
Emory University - Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
10
Barnes-Jewish Hospital - Siteman Cancer Center (Washington University - St. Louis)
St Louis, Missouri, United States, 63110
Actively Recruiting
11
Carolina Oncology Specialists
Hickory, North Carolina, United States, 28602
Actively Recruiting
12
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267
Actively Recruiting
13
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
14
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
15
Tennessee Oncology
Nashville, Tennessee, United States, 37203
Actively Recruiting
16
Vanderbilt - Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
17
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
18
Virginia Commonwealth University
Richmond, Virginia, United States, 23219
Actively Recruiting
19
Medical Oncology Associates - Summit Cancer Centers
Spokane, Washington, United States, 99208
Actively Recruiting
Research Team
P
Phillip Trieu
T
Tamra Madenwald
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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