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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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT06749886
Lead Sponsor Shanghai Pulmonary Hospital, Shanghai, China
Conditions
(from sponsor)		 Lung Cancer
Related terms Lung Neoplasms
Enrollment 22 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov