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

• Status: RECRUITING
• Trial end date: 2027-06-30

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.

• Phase: PHASE2

Details

• Lead Sponsor: Shanghai Pulmonary Hospital, Shanghai, China
• Treatments: Denosumab; Docetaxel; tislelizumab