drugset / Trial / NCT07004712

Efficacy and Biomarkers of the Second-line Treatment of Adebelizumab Combined With Irinotecan Liposome in Advanced Small Cell Lung Cancer

NCT07004712

Phase 2 Not yet recruiting 46 enrolled Peking University Cancer Hospital & Institute
NaSingle-groupOpen-labelTreatment

Summary

This study is an open, single-arm, single-center phase II clinical study, which aims to evaluate the efficacy and safety of adebelizumab combined with irinotecan liposome in the second-line treatment of advanced small cell lung cancer, explore biomarkers to predict the efficacy, and further select the dominant population in immunotherapy. In this study, 46 patients with extensive SCLC who had previously received immunotherapy combined with chemotherapy were enrolled. Subjects who met the enrollment conditions will be given adebelizumab combined with irinotecan liposome at the same time. After 4-6 cycles of treatment, if their condition has not progressed, they will be treated with adebelizumab until the disease progresses, toxicity can not be tolerated or other reasons specified in the scheme can be terminated. Subjects who finish the treatment will enter the follow-up period for safety follow-up and survival follow-up.

Timeline

Start
2025-06-01
Primary completion
2028-03-01
Completion
2028-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Adebelizumab Unknown 1200 mg Intravenous
Subject Irinotecan Small molecule 80 mg/m2 Intravenous