Combined Simvastatin and Irinotecan in Treating ES-SCLC Patients Relapsed From 1st Chemotherapy
Status:
Not yet recruiting
Trial end date:
2023-08-01
Target enrollment:
Participant gender:
Summary
This Phase II study was designed to evaluate the safety and efficacy of irinotecan in
combination with simvastatin compared with treatment with irinotecan alone in ES-SCLC
patients relapsed from first-line chemotherapy. Participants will be divided in a 1:1 ratio
to receive either irinotecan (4 cycles) + simvastatin (10 months) or irinotecan (4 cycles)
until progressive disease (PD) as assessed by the investigator using Response Evaluation
Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Treatment can be continued until
persistent radiographic PD or symptomatic deterioration.