OncoMatch/Clinical Trials/NCT06749886
An Exploratory Study of Tislelizumab in Combination with Chemotherapy in Immuno-experienced Patients with EGFR/ALK/ROS1-negative Advanced NSCLC in the Second-line Setting
Is NCT06749886 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Denosumab and tislelizumab for lung cancer.
Treatment: Denosumab · tislelizumab · Docetaxel — The goal of this clinical trial is to explore the efficacy and safety of denosumab in combination with tislelizumab and chemotherapy in the second-line treatment of immuno-experienced patients with EGFR/ALK/ROS1-negative advanced NSCLC. Primary endpoint: progression-free survival (PFS) assessed by investigators according to RECIST 1.1; Secondary endpoint: 1. Overall survival (OS) assessed by investigators according to RECIST 1.1; 2. Objective response rate (ORR) assessed by investigators according to RECIST 1.1; 3. Disease control rate (DCR) assessed by investigators according to RECIST 1.1; 4. Duration of response (DOR) assessed by investigators according to RECIST 1.1; Exploratory endpoint: bone metastasis-free survival. Participants will receive denosumab combined with tislelizumab and docetaxel.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: ALK wild-type
Required: EGFR wild-type
Required: ROS1 wild-type
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: checkpoint inhibitor — first-line
first-line treatment with immune checkpoint inhibitors and clinical benefit (PFS ≥ 3 months)
Cannot have received: docetaxel (docetaxel)
Patients on first-line docetaxel chemotherapy
Lab requirements
Blood counts
absolute neutrophil count ≥1.5×10^9/L, platelet count ≥ 80×10^9/L, hemoglobin ≥ 90g/L (no history of blood transfusion within 7 days, not corrected with G-CSF and other hematopoietic stimulating factors)
Kidney function
creatinine clearance ≥50ml/min (Cockcroft-Gault formula)
Liver function
total bilirubin levels ≤1.5 times the upper limit of normal (ULN) and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 times ULN, or for patients with liver metastases, AST and ALT levels ≤ 5 times ULN
Adequate hematologic function, defined as absolute neutrophil count ≥1.5×10^9/L, platelet count ≥ 80×10^9/L, hemoglobin ≥ 90g/L (no history of blood transfusion within 7 days, not corrected with G-CSF and other hematopoietic stimulating factors); adequate liver function, defined as total bilirubin levels ≤1.5 times the upper limit of normal (ULN) and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 times ULN, or for patients with liver metastases, AST and ALT levels ≤ 5 times ULN; adequate renal function, defined as creatinine clearance ≥50ml/min (Cockcroft-Gault formula); Adequate coagulation function, defined as the international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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