Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
Study NCT ID:
NCT05245994
Status:
UNKNOWN
Last Update Posted:
2022-02-18
First Post:
2022-01-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Open Label, Multicenter Phase 2 Study of Durvalumab (MEDI4736) + Olaparib as Maintenance Therapy in Chinese
Sponsor:
Li Zhang, MD
Organization:
Study Overview
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:
UNKNOWN
Status Verified Date:
2022-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: