First-line Treatment for Adenocarcinoma Patients With Epidermal Growth Factor Receptor (EGFR) Mutation

Phase 2

Completed

• Conditions: Pulmonary Cancer
• Interventions: Drug: Gefitinib

• Registration Number: NCT00344773
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to evaluate the overall objective tumor response rate (ORR) of Gefitinib.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-06-26
• Study First Submitted QC: 2006-06-26
• Study First Posted: 2006-06-27
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Results First Submitted: 2008-12-19
• Results First Submitted QC: 2010-05-11
• Status Verified: 2010-06
• Results First Posted: 2010-06-04
• Last Update Submitted: 2010-06-24
• Last Update Posted: 2010-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Patients require histological biopsy and paraffin block more than 5mg from the original tumour or metastatic site to perform EGFR mutational analysis
• WHO Performance Status 0-2
• No prior chemotherapy, biological or immunological therapy/surgery

Exclusion Criteria

• Any evidence of clinically active interstitial lung disease
• Newly diagnosed CNS metastases that have not yet been definitively treated with surgery /radiation
• Patients with previously diagnosed and treated CNS metastases or spinal cord compression

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gefitinib	Gefitinib	Gefitinib 250mg tablet once daily

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Had an Objective Response Rate(ORR) Based on Response Evaluation Criteria In Solid Tumors (RECIST) Criteria.	baseline to 12 months	Objective Response Rate (ORR) is defined as participants who had complete response (CR) or partial response(PR) divided by the total number of patients.; RECIST criteria: CR = disappearance of all target lesions PR = 30% decrease in the sum of the longest diameter of target lesions PD = 20% increase in the sum of the longest diameter of target lesions SD (stable disease) = small changes that do not meet above criteria

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	baseline to 4 months	Progression free survival calculated using Kaplan-Meier Product Limit. Median PFS was not able to be calculated because the rate of PFS was below 50% at the end of follow-up period. Therefore, PFS percentage at 4 months is provided.
Safety Profile: Participants With Adverse Events	baseline to end of study	Safety profile as defined by adverse events and serious adverse events throughtout the study period. Details listed in the SAE and Other AE section.
Overall Survival (OS)	baseline to 12 months	Median Overal survival was not able to be calculated because the rate of OS was below 50% at the end of follow-up period. Therefore, OS percentage at 12 months is provided.

Trial Locations

Locations (1)

Research Site; 🇰🇷 Seoul, Korea, Republic of