Irinotecan Liposome (II) or Etoposide Combined With Adebrelimab and Carboplatin in the Treatment of ES-SCLC

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorGuangzhou Institute of Respiratory Disease

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

Treatment groups

120 Participants
are divided into 2 treatment groups