Actively Recruiting
A Study on the Efficacy and Safety of Golidocitinib Combined With Tislelizumab and Chemotherapy as First-line Treatment for Advanced NSCLC
Led by Peking University Cancer Hospital & Institute · Updated on 2025-06-06
21
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study on the Efficacy and Safety of Golidocitinib Combined With Tislelizumab and Chemotherapy as First-line Treatment for Advanced NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide signed informed consent
- At least 18 years old with no gender restrictions
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
- Newly diagnosed locally advanced (stage IIIB/C) or metastatic (stage IV) NSCLC not suitable for surgery or radiotherapy
- PD-L1 expression of 1% or higher
- At least one measurable tumor lesion
- Adequate bone marrow and organ function including:
- Absolute neutrophil count of at least 1.5 x 10^9/L without growth factor support
- Platelet count of at least 100 x 10^9/L without transfusion or growth factor support
- Hemoglobin level of at least 9 g/dL without transfusion or erythropoietin
- Total bilirubin less than or equal to 1.5 times upper limit of normal (ULN), or up to 3 times ULN if diagnosed with Gilbert syndrome
- ALT and AST less than or equal to 2.5 times ULN, or up to 5 times ULN if liver metastases are present
- Blood creatinine less than or equal to 1.5 times ULN, or creatinine clearance of at least 50 mL/min
- If central nervous system metastases are present, neurological symptoms must be stable or absent for at least 2 weeks after local treatment, with no corticosteroids or antiepileptic drugs needed
- Women of childbearing potential must have a negative pregnancy test within 7 days prior to first dose and agree to effective contraception along with their male partners until 6 months after last dose
You will not qualify if you...
- Presence of EGFR 19 deletion, L858R mutation, or ALK/ROS-1 fusion gene mutations in lung adenocarcinoma
- Prior systemic chemotherapy, biological therapy, targeted therapy, or immunotherapy for advanced NSCLC
- Existing interstitial pneumonia, immune pneumonia, or interstitial lung changes
- Known meningeal, brainstem, spinal cord metastases, or active central nervous system metastases
- Current participation in other intervention clinical trials or recent palliative radiotherapy within 2 weeks
- Use of drugs or supplements affecting CYP3A that cannot be stopped before treatment
- History of solid organ or blood system transplants, or recent blood transfusions within 120 days
- Severe pulmonary function decline with FEV1 or DLCO less than 60% predicted
- Active autoimmune disease requiring systemic treatment within 2 years
- Immune deficiency or recent systemic immunosuppressive therapy (except low dose glucocorticoids)
- Other malignancies within 5 years except certain skin cancers
- Recent live vaccine administration within 30 days prior to treatment
- Active tuberculosis or positive tuberculosis tests without completed treatment
- Active infections including hepatitis B, hepatitis C, or HIV
- Allergy to study drugs or components
- Digestive system diseases or surgeries affecting drug absorption
- Any condition deemed unsuitable for study participation by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Peking University Cancer Hospital & Institute
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
Research Team
M
Minglei Zhuo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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