A Study on the Efficacy and Safety of Golidocitinib Combined With Tislelizumab and Chemotherapy as First-line Treatment for Advanced NSCLC
NCT06969612 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21
Last updated 2025-06-06
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
- DRUG
-
Tislelizumab
200 mg, intravenously on Day 1, every 3 weeks
- DRUG
-
Pemetrexed
administered via IV infusion
- DRUG
-
administered via IV infusion
- DRUG
-
administered via IV infusion
- DRUG
-
administered via IV infusion
- DRUG
-
Albumin Paclitaxel
administered via IV infusion
- DRUG
-
Golidocitinib
75mg, once a day orally
Sponsors & Collaborators
-
Peking University Cancer Hospital & Institute
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-05-15
- Primary Completion
- 2027-05-31
- Completion
- 2028-05-31
- FDA Drug
- Yes
Countries
- China
Study Locations
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