Third-line Treatment of Gefitinib in NSCLC Patients
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|ClinicalTrials.gov Identifier: NCT01933347|
Recruitment Status : Unknown
Verified February 2017 by Guangdong Association of Clinical Trials.
Recruitment status was: Active, not recruiting
First Posted : September 2, 2013
Last Update Posted : February 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer||Drug: Gefitinib||Phase 2|
- Primary Study Objective: To evaluate the disease control rate (DCR) of gefitinib as third-line retreatment in stage IIIB/IV NSCLC with EGFR 19del/L858R positive mutation patients who had benefited from first-line gefitinib treatment with EGFR 19del/L858R positive mutation and tumor progression after the second-line chemotherapy
- Secondary Study Objectives: To evaluate objective response rate (ORR), progressive-free survival (PFS), overall survival(OS) 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Third-line Treatment of Gefitinib in NSCLC Patients Who Had Received First-line Gefitinib With EGFR 19del/L858R Mutation and Tumor Progression After the Second-line Chemotherapy: a Single-arm, Prospective and Multi-center Study|
|Actual Study Start Date :||April 7, 2014|
|Actual Primary Completion Date :||October 10, 2016|
|Estimated Study Completion Date :||December 31, 2017|
Experimental: Gefitinib 250mg/d
Subjects will receive the oral administration of gefitinib 250mg/d until the tumor progression, perform scheduled visits in investigational sites at interview day and complete related examinations during follow-up period.
Subjects will receive the oral administration of gefitinib 250mg/d until the tumor progression.
Other Name: Iressa
- Disease Control Rate (DCR) [ Time Frame: week 8 ]
- objective response rate (ORR), progressive-free survival (PFS), overall survival(OS) [ Time Frame: until the death of last subject or 2 years after enrollment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01933347
|Nanjing General Hospital of Nanjing Military Command|
|Nanjing, Jiangsu, China, 210002|
|Principal Investigator:||Yong Song, Ph.D||Nanjing PLA General Hospital|