Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04870112
Status:
TERMINATED
Last Update Posted:
2024-03-08
First Post:
2021-04-16
Brief Title:
A Study to Evaluate Subcutaneous Durvalumab in Patients With Non-Small Cell Lung Cancer and Small Cell Lung Cancer
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Phase 12a Open-label Multicenter Study to Evaluate the Safety Pharmacokinetics and Preliminary Efficacy of Subcutaneous Durvalumab in Patients With Non-Small Cell and Small Cell Lung Cancer - SCope-D1
Status:
TERMINATED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
AstraZeneca has decided to stop further enrollment and the study was terminated when all patients in Part 1 completed their last study visit No safety issues or clinical concerns however have been identified for this study Part 2 was not initiated
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCope-D1
Brief Summary:
This study has 2 parts dose finding and dose confirmatory
In Part 1 the dose finding phase of the study there will be 3 or more dosing levels to find out what dose of durvalumab administered as an infusion under the skin acts similarly to durvalumab administered into a vein 24 participants with Non-Small Cell Lung Cancer will be enrolled for a 12 month treatment period and 3 months follow up
In Part 2 the dose confirmation phase of the study participants will receive the dose of durvalumab identified in Part 1 of the study The goal of Part 2 will be to learn more about the way that the body processes durvalumab when administered as an infusion under the skin Approximately 90 participants with Non-Small Cell Lung Cancer will be enrolled additionally up to 10 participants with Small Cell Lung Cancer who will receive concurrent chemotherapy will be enrolled for a 12 treatment period and a 3 month follow-up period
AstraZeneca has decided to stop further enrollment and the study was terminated when all patients in Part 1 Phase I completed their last study visit No safety issues or clinical concerns however have been identified for this study Part 2 Phase II was not initiated
In Part 1 the dose finding phase of the study there will be 3 or more dosing levels to find out what dose of durvalumab administered as an infusion under the skin acts similarly to durvalumab administered into a vein 24 participants with Non-Small Cell Lung Cancer will be enrolled for a 12 month treatment period and 3 months follow up
In Part 2 the dose confirmation phase of the study participants will receive the dose of durvalumab identified in Part 1 of the study The goal of Part 2 will be to learn more about the way that the body processes durvalumab when administered as an infusion under the skin Approximately 90 participants with Non-Small Cell Lung Cancer will be enrolled additionally up to 10 participants with Small Cell Lung Cancer who will receive concurrent chemotherapy will be enrolled for a 12 treatment period and a 3 month follow-up period
AstraZeneca has decided to stop further enrollment and the study was terminated when all patients in Part 1 Phase I completed their last study visit No safety issues or clinical concerns however have been identified for this study Part 2 Phase II was not initiated
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-006041-18 | EUDRACT_NUMBER | None | None |