RecruitingPhase 2NCT06749886

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

Enrollment

22 participants

Start Date

Nov 19, 2024

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is exploring whether re-using an immunotherapy drug called tislelizumab — combined with chemotherapy — can work as a second-line treatment in people with advanced non-small cell lung cancer (NSCLC) whose cancer did not respond well enough to first-line immunotherapy alone. The patients eligible do not have certain driver gene mutations like EGFR or ALK. **You may be eligible if...** - You are 18 or older - You have been diagnosed with Stage IV NSCLC (without bone metastases), confirmed by tissue testing - Your tumor does not have EGFR, ALK, or ROS1 mutations (or relevant targeted therapies are not available) - You previously received immunotherapy (a checkpoint inhibitor) as first-line treatment and had benefit for at least 3 months - You have at least one measurable tumor **You may NOT be eligible if...** - You have never received first-line immunotherapy - Your cancer progressed within 3 months of starting immunotherapy - You have received prior chemotherapy for this cancer - Your general health is too poor to tolerate additional treatment Talk to your doctor to see if this trial is right for you.

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

DRUGDenosumab

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

DRUGtislelizumab

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

DRUGDocetaxel

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

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NCT06749886


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