This study is a single-arm clinical trial designed to evaluate the safety and efficacy of golidocitinib in patients with refractory, immune-related hematologic toxicity in advanced lung cancer.
Able to provide a signed and dated informed consent form, including compliance with the Informed Consent Form (ICF) and the requirements and limitations listed in this protocol.
The subject is ≥18 years of age at the time of signing the ICF.
Has not experienced disease progression in the past two weeks and has a Eastern Cooperative Oncology Group (ECOG) score of 0-2, with a predicted survival of ≥12 weeks.
Pathologically or cytologically confirmed locally advanced (American Joint Committee on Cancer, AJCC 8th edition IIIB and IIIC stages) or metastatic (stage IV) non-small cell lung cancer, or extensive-stage small cell lung cancer (AJCC 8th edition TNM staging of lung cancer stage IV, or T3-4 disease caused by multiple pulmonary nodules with excessive disease spread, or tumor/nodule size too large for a tolerable radiation therapy plan).
Currently participating in an interventional clinical trial, or having received other investigational drugs or used investigational devices within 4 weeks prior to the first dose; any drug still in development requires a 5-half-life washout (or discussion with the research team);
Underwent major surgery (excluding diagnostic or biopsy, excluding vascular access) within 4 weeks prior to the first dose, or is expected to undergo major surgery during the study;
Received palliative radiation therapy within 2 weeks prior to the first dose;
Have experienced a serious arterial/venous thrombotic event within 6 months prior to the first dose, including cerebrovascular accidents (e.g., history of stroke or intracranial hemorrhage), deep vein thrombosis, and pulmonary embolism;
Single group
golidocitinib
DrugGolidocitinib treatment can be discontinued once clinical remission is achieved, with a maximum maintenance period of 12 weeks.
Clinical remission rate of immune-related hematologic toxicities
The proportion of subjects who achieved clinical remission of immune-related hematologic toxicities treated with golidocitinib (clinical remission is defined as a degraded hematologic toxicity grade within 1 week of golidocitinib use, a hematologic toxicity grade ≤1 within 2 weeks, and no relapse before discontinuation of treatment). This was assessed by the investigator based on laboratory indicators and the subject's clinical condition.
Negative conversion rate of SSA/Ro52 antibody
The proportion of subjects whose SSA/Ro52 antibody test results changed from positive to negative. This was assessed by the investigator based on laboratory indicators and the subjects' clinical condition.
Progression free survival
The duration from the start of immunotherapy to disease progression or death from any cause as determined by RECIST 1.1, regardless of whether the subject discontinued the investigational drug or received other anticancer treatments before disease progression. This assessment is conducted by the investigator based on the subject's imaging and clinical condition.
Overall survival
The time from the start of immunotherapy to the subject's death from any cause, regardless of whether the subject received other anticancer treatments. Assessed by the investigator based on the subject's clinical condition.
Adverse events
Incidence of adverse events/serious adverse events, severity as assessed by CTCAE v5.0, and relevance to the investigational drug.
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This trial is not recruiting at the moment. You can still explore other options:
