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
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• Be able to provide the informed consent form with signatures and signing dates, including compliance with the requirements and restrictions listed in the informed consent Form (ICF) and this protocol;

• At the time of signing the ICF, the age must be at least 18 years old, with no gender restrictions.

• The ECOG score is 0 or 1.

• Life expectancy ≥ 3 months;

• Histological or cytological examination confirms that the newly diagnosed NSCLC is locally advanced (IIIB/C) or metastatic (stage IV) that cannot undergo radical surgery or radiotherapy;

• PD-L1(22C3) ≥1%;

• At least one measurable lesion (RECIST v1.1);

• The bone marrow reserve and organ system functional reserve are sufficient, which can be summarized as follows:

• \- Under the condition of not receiving growth factor support, the absolute neutrophil count (ANC) was ≥ 1.5×109/L.

• \- Under the condition of not receiving growth factor support or blood transfusion, platelet count ≥ 100×109/L.

• \- In the absence of blood transfusion or reception of erythropoietin, hemoglobin ≥ 9 g/dL.

⁃ Total bilirubin ≤ 1.5 × ULN; If one has Gilbert syndrome (unconjured hyperbilirubinemia), the total bilirubin should be ≤ 3 × ULN.

⁃ ALT and AST≤ 2.5 × ULN. For patients with recorded liver metastases, the levels of AST and ALT are ≤ 5 × ULN.

⁃ Blood creatinine ≤ 1.5 × ULN, or creatinine clearance rate calculated by the Cockcroft-Gault method ≥ 50 mL/min, or urine creatinine clearance rate measured within 24 hours ≥ 50 mL/min.

• For patients with central nervous system metastases, the following conditions must be met before they can be enrolled:

• \- No neurological symptoms or stable symptoms for at least 2 weeks after local treatment, no need to use corticosteroids or antiepileptic drugs, and hormone therapy should be discontinued within 3 days before the administration of the first study drug;

⁃ If the brain metastases have received local treatment (radiotherapy or surgery), there should be a time window of ≥2 weeks before the first administration of the study treatment to ensure that the adverse events related to local treatment have been reduced to CTCAE ≤ grade 1.

⁃ Women of Childbearing Potential (WOCBP) must undergo a urine and/or serum (if the urine test cannot be confirmed as negative) pregnancy test within 7 days before the first medication, and the result must be negative; WOCBP or the male and his WOCBP partner should agree to take effective contraceptive measures from the date of signing the ICF until 6 months after using the last dose of the study drug.

Locations
Other Locations
China
Peking University Cancer Hospital & Institute
RECRUITING
Beijing
Contact Information
Primary
Minglei Zhuo
reyiza1993@126.com
+86 88196456
Time Frame
Start Date: 2025-05-15
Estimated Completion Date: 2028-05
Participants
Target number of participants: 21
Treatments
Experimental: Golidocitinib combined with tislelizumab and chemotherapy
Take tislelizumab and chemotherapy for 2 cycles; and then take tislelizumab for 2 cycles and golidocitinib for 6 weeks; after cycle 5, patients receive tislelizumab and chemotherapy until the patients were intolerant or the disease progressed.
Sponsors
Leads: Peking University Cancer Hospital & Institute

This content was sourced from clinicaltrials.gov