Ignite Creation Date:
2024-05-06 @ 1:56 AM
Last Modification Date:
2024-10-26 @ 11:11 AM
Study NCT ID:
NCT01933347
Status:
COMPLETED
Last Update Posted:
2020-02-06
First Post:
2013-08-28
Brief Title:
Third-line Treatment of Gefitinib in NSCLC Patients
Sponsor:
Guangdong Association of Clinical Trials
Organization:
Guangdong Association of Clinical Trials
Study Overview
Official Title:
Third-line Treatment of Gefitinib in NSCLC Patients Who Had Received First-line Gefitinib With EGFR 19delL858R Mutation and Tumor Progression After the Second-line Chemotherapy a Single-arm Prospective and Multi-center Study
Status:
COMPLETED
Status Verified Date:
2018-04
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:
The purpose of this study is to evaluate the disease control rate DCR of gefitinib as third-line retreatment in stage IIIBIV NSCLC with EGFR 19delL858R positive mutation patients who had benefited from first-line gefitinib treatment with EGFR 19delL858R positive mutation and tumor progression after the second-line chemotherapy
Detailed Description:
Primary Study Objective To evaluate the disease control rate DCR of gefitinib as third-line retreatment in stage IIIBIV NSCLC with EGFR 19delL858R positive mutation patients who had benefited from first-line gefitinib treatment with EGFR 19delL858R positive mutation and tumor progression after the second-line chemotherapy
Secondary Study Objectives To evaluate objective response rate ORR progressive-free survival PFS overall survivalOS and quality of life QoL of gefitinib as third-line retreatment in NSCLC patients To evaluate the safety of gefitinib as third-line treatment in NSCLC patients
Exploratory analyses To dynamically monitor EGFR mutation status and explore the relationship with clinical outcome
Secondary Study Objectives To evaluate objective response rate ORR progressive-free survival PFS overall survivalOS and quality of life QoL of gefitinib as third-line retreatment in NSCLC patients To evaluate the safety of gefitinib as third-line treatment in NSCLC patients
Exploratory analyses To dynamically monitor EGFR mutation status and explore the relationship with clinical outcome
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None