NCT05245994

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Li Zhang, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Lung Cancer
• Small Cell Lung Cancer
• Durvalumab

Interventions

Type	Name	Description
DRUG	Durvalumab, etoposide, and cisplatin/carboplatin followed by durvalumab and olaparib	Durvalumab 1500 mg intravenous infusion, started to be used simultaneously with chemotherapy at week 0 and continued after chemotherapy. Starting from week 0, the dose of etoposide + carboplatin or cisplatin in the study will not exceed the dose for specific indications in the product instructions (etoposide \[80 to 100mg/m2\] via intravenous infusion and carboplatin \[ The area under the curve (AUC) is 5-6\] by intravenous infusion or cisplatin \[75-80 mg/m2\] by intravenous infusion), using up to 4 cycles. The choice of platinum drugs is at the discretion of the investigator. The initial dose of olaparib is 300mg twice daily. Olaparib tablets should be taken at the same time each day, approximately 12 hours apart with one glass of water. The tablets should be swallowed whole and not chewed, crushed, dissolved or divided. Olaparib tablets can be taken with or without food.

Timeline

• Start date: 2021-08-21
• Primary completion: 2023-05-01
• Completion: 2023-11-01
• First posted: 2022-02-18
• Last updated: 2022-02-18

Locations

1 site across 1 country: China