About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Irinotecan liposome (II) combined with adebrelimab and carboplatin
- etoposide combined with adebrelimab and carboplatin