NCT01933347

Third-line Treatment of Gefitinib in NSCLC Patients

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Guangdong Association of Clinical Trials · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is 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

Detailed description

* 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

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Gefitinib	Subjects will receive the oral administration of gefitinib 250mg/d until the tumor progression.

Timeline

• Start date: 2014-04-07
• Primary completion: 2017-04-10
• Completion: 2018-04-10
• First posted: 2013-09-02
• Last updated: 2020-02-06

Locations

1 site across 1 country: China