Phase 3 Study Comparing N-803 Plus Tislelizumab or Prior Failed Immune Checkpoint Inhibitor and Docetaxel Versus Docetaxel Alone in Adults With Advanced or Metastatic Non-Small Cell Lung Cancer Resistant to Immune Checkpoint Therapy

What this Trial Is About

Researchers are conducting a randomized, open-label phase 3 clinical trial to compare the effectiveness and safety of two treatment combinations with docetaxel alone in people with advanced or metastatic non-small cell lung cancer NSCLC who have developed resistance to immune checkpoint inhibitor therapy. The study includes two groups one receiving N-803 plus tislelizumab and docetaxel, and the other receiving N-803 plus a prior failed checkpoint inhibitor and docetaxel. The trial explores how these combinations perform compared to docetaxel by itself in this specific patient population. Participants are divided into two cohorts and randomized to either the experimental treatments or docetaxel monotherapy. Treatments are given in repeated 3-week cycles. In cohort A, N-803, tislelizumab, and docetaxel are given during the first two cycles, followed by N-803 and tislelizumab alone from cycle 3 onward until the study ends. In cohort B, N-803, the prior failed checkpoint inhibitor, and docetaxel are administered in the first two cycles, then N-803 with the prior checkpoint inhibitor continue from cycle 3 onward. The control groups in both cohorts receive docetaxel alone every 3 weeks. Participants will attend regular study visits aligned with the treatment cycles, during which researchers will assess overall survival and monitor safety. The main measurement focuses on comparing survival between the experimental and control arms over approximately 12 months. The study involves follow-up visits and safety monitoring throughout the treatment period. The trial is sponsored by ImmunityBio, Inc. and plans to enroll adults aged 18 to 90 with confirmed stage IV NSCLC who meet specific health and treatment history criteria.

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