Ignite Creation Date:
2024-07-17 @ 11:15 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06480136
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-25
Brief Title:
SHR-A1921 Combined With Adebrelimab in the Treatment of Advanced NSCLC Who Failed the Previous Standard First-line Treatment
Sponsor:
Shanghai Pulmonary Hospital Shanghai China
Organization:
Shanghai Pulmonary Hospital Shanghai China
Study Overview
Official Title:
An Exploratory Clinical Study of SHR-A1921 Combined With Adebrelimab in the Treatment of Advanced NSCLC Who Failed the Previous Standard First-line Treatment
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
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:
This is a Phase II clinical study to evaluate the efficacy and safety of SHR-A1921 conbined with adebrelimab in advanced NSCLC who failed the previous first-line standard therapy Subjects in this study were treated with SHR-A1921 in combination with adebrelimab until disease progression intolerable toxicity occurs informed consent is withdrawn or other conditions requiring termination of medication whichever occurred first The maximum treatment time of adebrelimab is 35 cycles or 2 years whichever comes first and subjects can continue to be treated with SHR-A1921 until disease progression intolerable toxicity occurs informed consent is withdrawn or other conditions requiring termination of medication Primary objective of this study was to evaluate the efficacy of SHR-A1921 combined with adebrelimab in advanced NSCLC who failed the previous first-line standard therapy Secondary objective of this study was to evaluate the safety of SHR-A1921 combined with adebrelimab in advanced NSCLC who failed the previous first-line standard therapy Exploratory objective of this study was to evaluate the biomarker changes during treatment with SHR-A1921 combined with adebrelimab in patients with advanced NSCLC who failed the previous first-line standard therapy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None