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
Shanghai Pulmonary Hospital, Shanghai, China
22 participants
Nov 19, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Denosumab, 120 mg subcutaneous injection, every 21-28 days a cycle, given on the first day, a loading dose is given on d8 of the first cycle, and continued use
Tislelizumab, 200 mg intravenous infusion, every 21 days a cycle, given on the first day, and continued use
Docetaxel, 60 mg/m2 intravenous infusion, every 21 days a cycle, given on the first day, and continued use.
Locations(1)
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NCT06749886