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);
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Lead sponsor
Dizal (Jiangsu) Pharmaceutical Co., Ltd.
Collaborator