An Open Label, Multicenter Phase 2 Study of Durvalumab (MEDI4736) + Olaparib as Maintenance Therapy in Chinese

Lung Cancer Clinical Trial

Official title: An Open Label, Multicenter Phase 2 Study of Durvalumab (MEDI4736) + Olaparib as Maintenance Therapy in Patients With Extensive Stage Small-Cell Lung Cancer

Status Recruiting

Clinical Trial Summary

The purpose of this study was to evaluate the efficacy and safety of combining durvalumab with EP followed by durvalumab + olaparib maintenance therapy as first-line treatment in patients with extensive-disease small-cell lung cancer (SCLC).

Clinical Trial Description

This study is planned to enroll approximately 60 eligible patients in China. Patients who fulfill all the inclusion criteria and none of the exclusion criteria will receive 4 cycles of EP with durvalumab, then durvalumab + olaparib will be administered post-chemotherapy until confirmed progressive disease (PD).Tumor assessments will be performed at Screening as baseline with follow-up at Week 6 ±1 week from the date of the first cycle treatment, at Week 12 ±1 week from the date of the first cycle treatment, and then every 8 weeks ±1 week until confirmed objective disease progression. The primary endpoint is APF12, which is defined as the Proportion of patients alive and progression free at 12 months from the first date of the first-line treatment. ;

Related Conditions & MeSH terms

• Durvalumab
• Lung Cancer
• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

• NCT number: NCT05245994
• Study type: Interventional
• Source: Sun Yat-sen University
• Contact: LI ZHANG
• Phone: 020-87343533
• Email: zhangli@sysucc.org.cn
• Status: Recruiting
• Phase: Phase 2
• Start date: August 21, 2021
• Completion date: November 2023