OncoMatch/Clinical Trials/NCT06745908
ResQ201A: Clinical Trial Of N-803 Plus TISLELIZUMAB And DOCETAXEL Versus DOCETAXEL Monotherapy In Participants With Advanced Or Metastatic Non-Small Cell Lung Cancer
Is NCT06745908 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including N-803 and Tislelizumab for nsclc stage iv.
Treatment: N-803 · Tislelizumab · Docetaxel — This is a randomized, open-label, phase 3 clinical trial to compare the efficacy and safety of N-803 plus tislelizumab and docetaxel (experimental arm) versus docetaxel monotherapy (control arm). Enrolled participants will be randomized 2:1 to treatment in the experimental arm or the control arm. Participant 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 \[ALK\] vs OTHER AGA vs No AGA).
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Excluded: ALK fusion
Participants with AGA of ALK.
Allowed: EGFR mutation
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).
Allowed: ROS1 fusion
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).
Allowed: NTRK1 fusion
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).
Allowed: NTRK2 fusion
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).
Allowed: NTRK3 fusion
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).
Allowed: BRAF mutation
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).
Allowed: MET exon 14 skipping
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).
Allowed: RET fusion
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).
Allowed: KRAS mutation
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).
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: anti-PD-L1 therapy — Stage III, IV, or recurrent disease
acquired resistance to an immune checkpoint inhibitor, defined as disease progression immediately following an initial response or stable disease (≥ 6 months duration) to exactly 1 line of anti-PD-L1 or anti-CTLA-4 therapy (for Stage III, IV, or recurrent disease) that was given alone or in combination with chemotherapy.
Must have received: anti-CTLA-4 therapy — Stage III, IV, or recurrent disease
acquired resistance to an immune checkpoint inhibitor, defined as disease progression immediately following an initial response or stable disease (≥ 6 months duration) to exactly 1 line of anti-PD-L1 or anti-CTLA-4 therapy (for Stage III, IV, or recurrent disease) that was given alone or in combination with chemotherapy.
Cannot have received: tyrosine kinase inhibitor
Exception: Participants who have been treated with a prior tyrosine kinase inhibitor (TKI) must receive additional approved targeted therapy, if locally available and clinically appropriate, for the applicable genomic alteration, or the participant will not be allowed in the study.
Participants who have been treated with a prior tyrosine kinase inhibitor (TKI) must receive additional approved targeted therapy, if locally available and clinically appropriate, for the applicable genomic alteration, or the participant will not be allowed in the study.
Lab requirements
Blood counts
Absolute lymphocyte count < institutional ULN; ANC < 1,500/mm3; Platelet count < 100,000/mm3; Hemoglobin < 9.0 g/dL
Kidney function
Serum creatinine > 2.0 mg/dL or 177 μmol/L or creatinine clearance < 40 mL/min
Liver function
Total bilirubin greater than the ULN (unless Gilbert's syndrome); AST or ALT > 1.5 × ULN; ALP > 2.5 × ULN
Inadequate organ function, evidenced by the following laboratory results: Absolute lymphocyte count < institutional upper limit of normal (ULN). Absolute neutrophil count < 1,500 cells/mm3. Platelet count < 100,000 cells/mm3. Total bilirubin greater than the ULN; unless the participant has documented Gilbert's syndrome). Aspartate aminotransferase (AST [serum glutamic-oxaloacetic transaminase; SGOT]) or alanine aminotransferase (ALT [serum glutamic pyruvic transaminase; SGPT]) > 1.5 × ULN. Alkaline phosphatase (ALP) levels > 2.5 × ULN. Hemoglobin < 9.0 g/dL. Serum creatinine > 2.0 mg/dL or 177 μmol/L or creatinine clearance < 40 mL/min (using the Cockcroft-Gault formula below).
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 →
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