NCT06969612

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• NSCLC (Advanced Non-small Cell Lung Cancer)

Interventions

Type	Name	Description
DRUG	Tislelizumab	200 mg, intravenously on Day 1, every 3 weeks
DRUG	Pemetrexed	administered via IV infusion
DRUG	Cisplatin	administered via IV infusion
DRUG	Carboplatin	administered via IV infusion
DRUG	Paclitaxel	administered via IV infusion
DRUG	Albumin Paclitaxel	administered via IV infusion
DRUG	Golidocitinib	75mg, once a day orally

Timeline

• Start date: 2025-05-15
• Primary completion: 2027-05-01
• Completion: 2028-05-01
• First posted: 2025-05-14
• Last updated: 2025-06-06

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study