Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06448754
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-06-04
Brief Title:
Volrustomig Priming Regimens Exploratory Phase II Platform Study
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Phase II Open-label Study to Evaluate the Safety Tolerability Pharmacokinetics Immunogenicity and Antitumor Activity of Volrustomig Priming Regimens in Combination With Other Anticancer Agents in Participants With Solid Tumors eVOLVE-01
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
eVOLVE-01
Brief Summary:
Purpose of this study is to assess the safety tolerability pharmacokinetics immunogenicity and antitumor activity of volrustomig in combination with other anticancer drugs in participants with specified solid tumors
Detailed Description:
This is a platform randomized open-label multicenter global study
Enrolled participants with Stage IV non-squamous non-small cell lung cancer NSQ NSCLC who are treatment-naïve and have not received previous treatment for advanced or metastatic disease
These participants will be randomized in a 11 ratio to one of the two treatment arms Arm 1A and Arm 1B
Both arms will test a volrustomig dosing in combination with chemotherapy
Enrolled participants with Stage IV non-squamous non-small cell lung cancer NSQ NSCLC who are treatment-naïve and have not received previous treatment for advanced or metastatic disease
These participants will be randomized in a 11 ratio to one of the two treatment arms Arm 1A and Arm 1B
Both arms will test a volrustomig dosing in combination with chemotherapy
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 |
|---|---|---|---|
| 2023-509482-20 | OTHER | EU CT | None |