This is an open-label, single-arm, phase 2 study to evaluate the safety and efficacy of golidocitinib with PD-1 inhibitors as maintenance treatment in patients with previously untreated extensive-stage small cell lung cancer.
Able to provide a signed and dated informed consent form, including compliance with the requirements and restrictions listed in the ICF and this protocol;
Subjects are ≥ 18 years old when signing the ICF;
Subjects have an ECOG performance status score of 0 or 1 and have not deteriorated in the past 2 weeks;
Life expectancy ≥ 3 months;
Histopathological confirmation of the presence of mixed NSCLC and SCLC components;
The presence of spinal cord compression or meningeal metastasis;
Systemic treatment with Chinese patent medicines with anti-lung cancer indications or immunomodulatory drugs (including thymosin, interferon, interleukin, excluding local use for the control of pleural effusion) within 2 weeks before the first dose;
Currently participating in interventional clinical research treatment, or receiving other research drugs or using research devices within 4 weeks before the first dose; any drug still in the development stage needs to be washed out for 5 half-lives (or discussed with the research team);
Single group
golidocitinib with PD-1 inhibitors
DrugDose escalation: 75/150mg golidocitinib with PD-1 inhibitors as maintenance treatment after 4 cycles of PD-1 inhibitors and chemotherapy. Dose expansion: Selected dose (75mg or 150mg) of golidocitinib with PD-1 inhibitors as maintenance treatment after 4 cycles of PD-1 inhibitors and chemotherapy.
Progression-Free Survival (PFS)
Time from the subject started treatment to disease progression or death due to any cause based on the investigators' evaluation
Overall Survival (OS)
Time from the subject started treatment to death due to any cause based on the investigators' evaluation
Safety and Tolerability
Incidence, nature, and severity of adverse events (AEs), graded according to NCI-CTCAE v5.0, including immune-related AEs and serious AEs
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Lead sponsor
Dizal (Jiangsu) Pharmaceutical Co., Ltd.
Collaborator
