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 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 histolog

Trial Details

NCT ID

NCT06745908

Phase

PHASE3

Sponsor

ImmunityBio, Inc.

Status

RECRUITING

Cancer Type

Lung Cancer

Interventions

N-803
Tislelizumab
Docetaxel
Prior failed checkpoint inhibitor

Locations (sample)

Springdale, Arkansas, United States|36.18674,-94.12881
El Segundo, California, United States|33.91918,-118.41647
Fountain Valley, California, United States|33.70918,-117.95367
Glendale, California, United States|34.14251,-118.25508
Los Alamitos, California, United States|33.80307,-118.07256

Key Eligibility Criteria

Age ≥ 18 years old.
Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committe…
Pathologically confirmed stage IV NSCLC disease.
Have acquired resistance to a regional Health Authority-approved immune plus platinum-based chemotherapy, defined as disease progression immediatel…

For full eligibility, visit ClinicalTrials.gov.

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