Actively 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
Led by ImmunityBio, Inc. · Updated on 2026-05-05
507
Participants Needed
19
Research Sites
169 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official 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 years or older
- Able to understand and provide signed informed consent
- Pathologically confirmed stage IV non-small cell lung cancer (NSCLC)
- Acquired resistance to approved immune plus platinum-based chemotherapy
- For cohort A, documented actionable genomic alterations with prior targeted therapy as applicable
- ECOG performance status of 0 to 2
- Measurable tumor lesions per RECIST v1.1
- Life expectancy of at least 3 months
- Ability to attend required study visits and follow-up
- Agreement to use effective contraception if of childbearing potential or male
- For participants with HIV, receiving antiretroviral therapy with undetectable viral load within 6 months prior
You will not qualify if you...
- Active systemic autoimmune disease requiring treatment or recent immunosuppression
- History of severe drug-induced skin reactions or immune-mediated reactions
- History of stem cell or organ transplant requiring immunosuppression
- For cohort A, presence of ALK genomic alteration
- Active hepatitis B or C infection unless resolved or well-controlled
- Active infection requiring antibiotic therapy
- Known active CNS metastases or carcinomatous meningitis
- Body weight 40 kg or less at screening
- Treatment with CYP3A4 inhibitors
- Recent live vaccine within 4 weeks prior to study drug
- History of inflammatory bowel disease
- Severe hypersensitivity to docetaxel or related drugs
- Major surgery within 28 days prior to randomization without full recovery
- Inadequate organ function based on lab results including blood counts, liver enzymes, and kidney function
- Cirrhosis with complications or clinically significant ascites
- Participation in another investigational drug study within 21 to 28 days prior
- Pregnant or nursing women
- History of allergic reactions to tislelizumab or prior immunotherapy adverse reactions leading to discontinuation
- Confinement by court order or authority
- History of malignancy other than NSCLC except certain treated cancers (cohort B exclusion)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
T
Tamra Madenwald
CONTACT
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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