RecruitingPhase 1NCT06969612

A Study on the Efficacy and Safety of Golidocitinib Combined With Tislelizumab and Chemotherapy as First-line Treatment for Advanced NSCLC

A Prospective, Phase IB Clinical Study on the Efficacy and Safety of Golidocitinib Combined With Tislelizumab and Chemotherapy as First-line Treatment for Advanced NSCLC


Sponsor

Peking University Cancer Hospital & Institute

Enrollment

21 participants

Start Date

May 15, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn if golidocitinib combined with tislelizumab and chemotherapy works in advanced NSCLC with PD-L1≥1%. The main question it aims to answer is: Does the combination of golidocitinib with tislelizumab and chemotherapy can prolong the progression-free survival of patients with advanced NSCLC? Participants will: Take tislelizumab and chemotherapy for 2 cycles; and then take tislelizumab and golidocitinib for 2 cycles; after cycle 5, patients receive tislelizumab and chemotherapy until the patients were intolerant or the disease progressed.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three drugs — golidocitinib (a JAK inhibitor), tislelizumab (an immunotherapy drug), and standard chemotherapy — as a first-line treatment for people with advanced non-small cell lung cancer (NSCLC) whose tumors express a protein called PD-L1. **You may be eligible if...** - You are 18 or older with newly diagnosed, locally advanced, or metastatic NSCLC - Your tumor expresses PD-L1 (at least 1% of tumor cells) - You have not previously received chemotherapy, immunotherapy, or targeted therapy for advanced disease - You have at least one measurable tumor on scans - Your overall health and organ function are adequate **You may NOT be eligible if...** - Your lung cancer has a specific EGFR, ALK, or ROS-1 gene mutation (if you have lung adenocarcinoma) - You have active autoimmune disease or are on immune-suppressing medications - You have previously had a lung transplant or bone marrow transplant - You have active tuberculosis, hepatitis B, hepatitis C, or HIV - You are pregnant or breastfeeding 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

DRUGTislelizumab

200 mg, intravenously on Day 1, every 3 weeks

DRUGPemetrexed

administered via IV infusion

DRUGCisplatin

administered via IV infusion

DRUGCarboplatin

administered via IV infusion

DRUGPaclitaxel

administered via IV infusion

DRUGAlbumin Paclitaxel

administered via IV infusion

DRUGGolidocitinib

75mg, once a day orally


Locations(1)

Peking University Cancer Hospital & Institute

Beijing, Beijing Municipality, China

View Full Details on ClinicalTrials.gov

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NCT06969612


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