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RECRUITING
NCT06749886
PHASE2

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

Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

22

Start Date

2024-11-19

Completion Date

2027-06-30

Last Updated

2024-12-27

Healthy Volunteers

No

Conditions

Interventions

DRUG

Denosumab

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

DRUG

tislelizumab

Tislelizumab, 200 mg intravenous infusion, every 21 days a cycle, given on the first day, and continued use

DRUG

Docetaxel

Docetaxel, 60 mg/m2 intravenous infusion, every 21 days a cycle, given on the first day, and continued use.

Locations (1)

Shanghai Pulmonary Hospital

Shanghai, China