Actively Recruiting
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
Led by Peking University Cancer Hospital & Institute · Updated on 2025-06-06
21
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether the combination of golidocitinib with tislelizumab and chemotherapy can improve progression-free survival in patients with advanced non-small cell lung cancer (NSCLC) who have a PD-L1 expression level of 1% or higher. This phase 1B clinical study focuses on patients newly diagnosed with locally advanced or metastatic NSCLC who cannot undergo surgery or radiotherapy. The study is sponsored by the Peking University Cancer Hospital & Institute and aims to understand the efficacy and safety of this combination as a first-line treatment. Participants will first receive two cycles of tislelizumab and chemotherapy, followed by two cycles of tislelizumab combined with golidocitinib taken orally daily for six weeks. After completing these five cycles, patients will continue treatment with tislelizumab and chemotherapy until they either cannot tolerate it or their disease progresses. Chemotherapy drugs used may include pemetrexed, cisplatin, carboplatin, paclitaxel, or albumin paclitaxel, delivered via intravenous infusion, while tislelizumab is given intravenously every three weeks. During the study, participants will be closely monitored with assessments including measurable tumor lesions and organ function tests. The main outcome measured is progression-free survival up to about 24 months. Secondary outcomes include response rates, duration and timing of responses, overall survival up to 60 months, and adverse events over approximately two years. Participants will be followed regularly throughout the treatment and evaluation periods to track these outcomes and ensure safety.
CONDITIONS
Brief 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
- Aged 18 years or older
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- Life expectancy of at least 3 months
- Newly diagnosed locally advanced (IIIB/C) or metastatic (stage IV) NSCLC not suitable for surgery or radiotherapy
- PD-L1 expression of 1% or higher by 22C3 test
- At least one measurable lesion according to RECIST v1.1
- Adequate bone marrow and organ function including specified blood counts and liver/kidney function tests
- For those with central nervous system metastases: stable or no neurological symptoms for at least 2 weeks after local treatment and no corticosteroid or antiepileptic use
- Women of childbearing potential must have a negative pregnancy test and agree to effective contraception until 6 months after last dose
You will not qualify if you...
- Presence of EGFR 19 deletion, L858R mutation, ALK or ROS-1 fusion gene mutations in lung adenocarcinoma
- Prior systemic chemotherapy, biological therapy, targeted therapy or immunotherapy for advanced NSCLC
- Known interstitial or immune pneumonia or interstitial lung changes
- Active central nervous system metastases including meningeal, brainstem, or spinal cord metastases
- Participation in other intervention clinical trials or recent palliative radiotherapy within specified time frames
- Use of drugs affecting CYP3A enzyme that cannot be discontinued before treatment
- History of solid organ or blood system transplant
- Severe pulmonary function decline or active interstitial lung disease
- Active autoimmune disease requiring systemic treatment within past 2 years
- Immune deficiency or recent systemic immunosuppressive therapy
- Other malignancies within 5 years except certain skin cancers
- Recent live vaccine administration
- Active infections including hepatitis B, hepatitis C, or HIV unless controlled
- Allergy to study drugs or their components
- Conditions affecting drug absorption such as severe digestive diseases or surgeries
- Any other conditions that the researcher deems unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 24 months
Participants receive tislelizumab and chemotherapy for 2 cycles; then receive tislelizumab for 2 cycles combined with golidocitinib for 6 weeks; after cycle 5, participants continue receiving tislelizumab and chemotherapy until they are intolerant or the disease progresses.
Infusions every 3 weeks with daily oral medication during the golidocitinib phase
Trial Site Locations
Total: 1 location
1
Peking University Cancer Hospital & Institute
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
Research Team
M
Minglei Zhuo
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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