Combined Simvastatin and Albumin Paclitaxel in Treating ES-SCLC Patients Relapsed From 1st Chemotherapy
Status:
Recruiting
Trial end date:
2022-12-30
Target enrollment:
Participant gender:
Summary
This Phase II study was designed to evaluate the safety and efficacy of albumin paclitaxel in
combination with simvastatin compared with treatment with albumin paclitaxel alone in ES-SCLC
patients relapsed from first-line chemotherapy. Participants will be divided in a 1:1 ratio
to receive either albumin paclitaxel (4 cycles) + simvastatin (10 months) or albumin
paclitaxel (4 cycles) until progressive disease (PD) as assessed by the investigator using
Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or symptomatic
deterioration.