Clinical Trial of N-803 Plus Tislelizumab or Prior Failed Immune Checkpoint Inhibitor and Docetax… (NCT06745908) | Clinical Trial Compass
RecruitingPhase 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 In
United States507 participantsStarted 2025-10-01
Plain-language summary
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).
Who can participate
Age range18 Years – 90 Years
SexALL
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Inclusion 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 Committee (IEC) guidelines.
✓. Pathologically confirmed stage IV NSCLC disease.
✓. Have acquired resistance to a regional Health Authority-approved immune plus platinum-based chemotherapy, defined as disease progression immediately following an initial response (of any duration) or stable disease (approximately 6 months duration \[± 2 weeks\]). Participants who received anti-PD-1/anti-PD-L1 mAb as first-line therapy may have received the combination of platinum-based chemotherapy and anti-PD-1/anti-PD-L1 mAb in the second line. Participants must have received platinum chemotherapy to be eligible. Participants must have received anti-PD-1/anti-PD-L1 mAb in their immediate prior line of therapy to be eligible.
✓. Participants with AGA must have 1 or more documented AGA(s): EGFR, ROS1, neurotrophic tyrosine receptor kinase (NTRK), B rapidly accelerated fibrosarcoma (BRAF), mesenchymal epithelial transition (MET) exon 14 skipping, rearranged during transfection (RET), Kirsten Rat sarcoma (KRAS) and HER2.
✓. Participants with AGA must meet the following criteria for advanced or metastatic NSCLC. Participants who have been treated with 1 or 2 prior lines of applicable targeted therapy that is locally approved (and is standard of care) for the participant's genomic alteration at the time of screening:
What they're measuring
1
Compare Overall Survival between the experimental and control arms
✓. Participants who have tumors with EGFR L858R or exon 19 deletion mutations must have received prior osimertinib.
✓. Participants who received a targeted agent as adjuvant therapy for early-stage disease must have relapsed or progressed while on the treatment or within 6 months of the last dose or received at least one additional course of targeted therapy for the same genomic alteration (which may or may not be same agent used in the adjuvant setting) for relapsed/progressive disease.
Exclusion criteria
✕. Systemic autoimmune disease currently requiring treatment (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease, or autoimmune disease associated with lymphoma). The participant must have been off treatment for 180 days.
✕. History of any of the following: drug-induced severe cutaneous adverse reaction (SCAR), including, but not limited to Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), or dose-limiting immune-mediated reactions.
✕. History of allogeneic hematopoietic stem cell transplant or organ transplant requiring immunosuppression; or history of pneumonitis or interstitial lung disease requiring treatment with systemic steroids; or a history of receiving systemic steroid therapy or any other immunosuppressive medication ≤ 3 days prior to study initiation. Daily steroid replacement therapy (eg, prednisone or hydrocortisone) and corticosteroids used to manage AEs are permitted.
✕. Participants with AGA of ALK.
✕. History of known active hepatitis B or C infection to be assessed within 6 months prior to enrollment using locally accepted standard of care measurements. (Resolved cases are allowed.)
✕. Active infection requiring antibiotic therapy.
✕. Have known active central nervous system (CNS) metastases, carcinomatous meningitis, and/or spinal cord compression.