Comparison of Teniposide, Cisplatin and Serplulimab Regimen With Etoposide, Cisplatin and Serplulimab Regimen for Treatment of Extensive Stage Small Lung Cancer, a Random, Open Label, Positive Control, Multicenter Study
To compare the efficacy and safety between teniposide, cisplatin and serplulimab regimen and etoposide, cisplatin and serplulimab regimen in the treatment of extensive stage small lung cancer
• Has not received systematic treatment for extensive stage small cell lung cancer in the past
• Extensive stage small cell lung cancer patients who have been pathologically proven to be intolerant to synchronous radiotherapy and chemotherapy
• Patients who have previously received radiotherapy and chemotherapy for limited stage SCLC and have had an untreatable interval of at least 6 months from the end of systemic treatment to SCLC recurrence
• Lesions can only be considered measurable if there is clear progression of a previously irradiated lesion after radiotherapy, and the previously irradiated lesion is not the only one
• Age≥18 years
• ECOG: 0-1
• Expected survival time exceeds 3 months
• Hb≥100g/L; ANC≥1.5×109/L; PLT≥100×109/L; WBC≥3.0×109/L; ALT and AST≤2.5×ULN(with tumor liver metastases, ≤5×ULN); TBIL≤1.5×ULN(with tumor liver metastases,≤3×ULN); Cr≤1.5×ULN or EGFR≥50ml/min; APTT, INR, PT≤1.5×ULN; LVEF≥50%
• Women of childbearing age should agree to use contraceptive measures during the study period and within 6 months after the end of the study. Serum pregnancy test negative within 28 days prior to enrollment in the study, and must be a non lactating subject. Men should be subjects who agree to use contraception during the study period and within 6 months after the end of the study period
• The subjects should sign an informed consent form and had good compliance