This study is a prospective, randomized, parallel, multicenter phase II study aimed at evaluating the efficacy and safety of irinotecan liposome (II) or etoposide combined with adebrelimab and carboplatin as first-line treatment for extensive stage small cell lung cancer. The primary endpoint of the study was the 1-year overall survival rate.
Pathologically confirmed small cell lung cancer (SCLC), staged as extensive-stage SCLC (ES-SCLC) according to the VALG staging system;
No prior systemic treatment received;
At least a 6-month interval between the last treatment (radiation therapy and chemotherapy) and diagnosis of extensive-stage SCLC;
Showing at least one target lesion (RECIST 1.1) that has not been previously irradiated;
Histologically or cytologically confirmed mixed small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC);
Previous treatment with immune checkpoint inhibitors, or treatment with irinotecan or other DNA topoisomerase inhibitors;
Use of a strong CYP3A4 inducer within 2 weeks prior to the first dose of the investigational drug, or a strong CYP3A4 inhibitor or UGT1A1 inhibitor within 1 week prior to the first dose;
Presence of clinically symptomatic brain metastasis, leptomeningeal metastasis, or spinal cord compression;
Parallel
Irinotecan liposome (II) combined with adebrelimab and carboplatin
DrugIrinotecan liposome (II) + adebrelimab + carboplatin
etoposide combined with adebrelimab and carboplatin
Drugetoposide + adebrelimab + carboplatin
1-year OS rate
The proportion of patients who are still alive after one year of treatment.
Progression-free survival (PFS)
Time from start of patient's treatment to disease progression or death from any cause.
Overall survival (OS)
Time from patient randomization to patient death from any cause.
Objective response rate (ORR)
Proportion of patients whose tumor volume shrinks to a pre-specified value and who can maintain the minimum timeframe requirement, as the sum of the proportion in complete and partial remission.
Disease control rate（DCR）
Number of cases in remission (PR+CR) and stable lesions (SD) after treatment as a percentage of evaluable cases.
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