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

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

Official Title
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An Open-label, Multi-centre Study to Evaluate Efficacy and Safety of Gefitinib as the First-line Treatment for Locally Advanced (IIIB), Metastatic (IV) or Recurrent Pulmonary Adenocarcinoma Patients With Epidermal Growth Factor Receptor (EGFR) Mutation.

Conditions
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Pulmonary Cancer

Intervention / Treatment
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* Drug: Gefitinib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gefitinib<br>Gefitinib 250mg tablet once daily | Drug: Gefitinib<br>* 250mg tablet oral tablet once daily<br>* Other names: IRESSA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Had an Objective Response Rate(ORR) Based on Response Evaluation Criteria In Solid Tumors (RECIST) Criteria. | 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 | baseline to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival (PFS) | 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. | baseline to 4 months | 
| Overall Survival (OS) | 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. | baseline to 12 months | 
| Safety Profile: Participants With Adverse Events | Safety profile as defined by adverse events and serious adverse events throughtout the study period. Details listed in the SAE and Other AE section. | baseline to end of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Locally advanced (IIIB) pulmonary adenocarcinoma with EGFR mutation, Metastatic (IV) pulmonary adenocarcinoma with EGFR mutation, Recurrent pulmonary adenocarcinoma with EGFR mutation