OncoMatch/Clinical Trials/NCT06745908
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
Is NCT06745908 recruiting? Yes, currently enrolling (Sep 2026). This Phase 3 trial studies multiple treatments including N-803 and Tislelizumab for nsclc stage iv.
Treatment: N-803 · Tislelizumab · Docetaxel · Prior failed checkpoint inhibitor — 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).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Chemotherapy
Other
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR l858r
Participants who have tumors with EGFR L858R or exon 19 deletion mutations must have received prior osimertinib
Required: EGFR exon 19 deletion
Participants who have tumors with EGFR L858R or exon 19 deletion mutations must have received prior osimertinib
Required: ROS1 gene alteration
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
Required: NTRK1 gene alteration
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
Required: NTRK2 gene alteration
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
Required: NTRK3 gene alteration
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
Required: BRAF gene alteration
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
Required: MET exon 14 skipping
mesenchymal epithelial transition (MET) exon 14 skipping
Required: RET gene alteration
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
Required: KRAS gene alteration
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
Required: HER2 (ERBB2) gene alteration
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
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: platinum-based chemotherapy
Participants must have received platinum chemotherapy to be eligible
Must have received: anti-PD-1 therapy — immediate prior line
Participants must have received anti-PD-1/anti-PD-L1 mAb in their immediate prior line of therapy to be eligible
Must have received: targeted therapy — for actionable genomic alteration
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
Must have received: osimertinib (osimertinib) — for EGFR L858R or exon 19 deletion
Participants who have tumors with EGFR L858R or exon 19 deletion mutations must have received prior osimertinib
Cannot have received: allogeneic hematopoietic stem cell transplant
History of allogeneic hematopoietic stem cell transplant or organ transplant requiring immunosuppression
Cannot have received: organ transplant requiring immunosuppression
History of allogeneic hematopoietic stem cell transplant or organ transplant requiring immunosuppression
Lab requirements
Blood counts
absolute lymphocyte count < LLN; absolute neutrophil count ≤ 1,500 cells/mm3; platelet count ≤ 100,000 cells/mm3; hemoglobin < 9.0 g/dL
Kidney function
serum creatinine > 2.0 mg/dL or 177 μmol/L or creatinine clearance < 40 mL/min (Cockcroft-Gault formula)
Liver function
AST/ALT > 1.5 × ULN; ALP > 2.5 × ULN; total bilirubin > 1.5 × ULN unless Gilbert's syndrome; exclusion if Child-Pugh B or worse, hepatic encephalopathy, or clinically meaningful ascites from cirrhosis
Inadequate organ function, evidenced by the following laboratory results: Absolute lymphocyte count < LLN; absolute neutrophil count ≤ 1,500 cells/mm3; platelet count ≤ 100,000 cells/mm3; hemoglobin < 9.0 g/dL; serum creatinine > 2.0 mg/dL or 177 μmol/L or creatinine clearance < 40 mL/min; AST/ALT > 1.5 × ULN; ALP > 2.5 × ULN; total bilirubin > 1.5 × ULN unless Gilbert's syndrome; exclusion if Child-Pugh B or worse, hepatic encephalopathy, or clinically meaningful ascites from cirrhosis
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Highlands Oncology Group · Springdale, Arkansas
- Chan Soon-Shiong Institute for Medicine · El Segundo, California
- MemorialCare - Orange Coast Medical Center · Fountain Valley, California
- OPN Healthcare INC · Glendale, California
- OPN Healthcare INC/ Cancer and Blood Specialty Clinic · Los Alamitos, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06745908 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior allogeneic hematopoietic stem cell transplant, organ transplant requiring immunosuppression disqualifies patients from enrollment.
Does this trial require EGFR?
Yes, EGFR l858r is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR exon 19 deletion is a required biomarker for enrollment.
Does this trial require ROS1?
Yes, ROS1 gene alteration is a required biomarker for enrollment.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Is there an age limit?
Yes. Patients must be 90 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify