Efficacy, Safety, Tolerability of Gefitinib as 1st Line in Caucasian Patients With EGFR Mutation Positive Advanced NSCLC

Study Overview
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Brief Summary
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This study is carried out to see how Caucasian patients with lung cancer which has EGFR mutation will respond to gefitinib (IRESSA™) as a first line treatment. Safety data will also be collected and analysed to confirm that treatment with gefitinib is safe and well tolerated.

Detailed Description
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An Open Label, Multicentre, Single Arm Study to Characterise the Efficacy, Safety and Tolerability of Gefitinib 250 mg (IRESSA™) as First line Treatment in Caucasian Patients, who have Epidermal Growth Factor Receptor (EGFR) Mutation Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Official Title
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An Open Label, Multicentre, Single Arm Study to Characterise the Efficacy, Safety and Tolerability of Gefitinib 250 mg (IRESSA™) as First Line Treatment in Caucasian Patients, Who Have Epidermal Growth Factor Receptor (EGFR) Mutation Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Conditions
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Caucasian Patients With EGFR Mutation Positive Advanced NSCLC

Intervention / Treatment
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* Drug: Gefitinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Locally advanced or metastatic non-small cell lung cancer (i.e. cancer that has spread from where it started) which is EGFR mutation positive Caucasian female or male patients aged 18 years or over Measurable disease, i.e. at least one lesion, not previously irradiated, as ≥ 10 mm in the longest diameter (≥ 15 mm in short axis for lymph node ) Exclusion Criteria: Prior adjuvant chemotherapy or other systemic anti-cancer treatment less than 6 month, or palliative radiotherapy less than 4 weeks prior to start of study treatment. Brain metastases or spinal cord compression, unless treated and stable without steroids Any clinically significant illness, which will jeopardize the patients' safety and their participation in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 130 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>gefitinib 250mg tablet | Drug: Gefitinib<br>* 250mg tablet oral, once daily until objective disease progression is documented or until other discontinuation criterion is met<br>* Other names: IRESSA™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) (Investigator) | % of patients in the Full analysis set who have a complete response [CR] or partial response [PR] confirmed by repeat imaging at least 4 weeks later with no evidence of progression between confirmation visits (as defined by Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1)). CR: disappearance of all target lesions (TLs) & non-target lesions (NTLs). PR: >= 30% decrease in the sum of diameters compared to baseline (with no evidence of progression) and the NTLs are at least stable with no evidence of new lesions. Outcome is based on measurements made at site by investigator. | Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Control Rate (DCR) (Investigator) | DCR is calculated as the % of the FAS patient population with a best visit response of CR, PR (a visit response of CR or PR which is confirmed at least 4 weeks later) or stable disease (SD). SD is defined as no evidence of CR, PR or progression and must have occurred at a minimum of 6 weeks after first dose of study treatment. (progression is defined as ≥20% increase in the sum of the diameters of target lesions from minimum; clinically significant progression in non-target lesions; the presence of a new lesion or death). Outcome is based on measurements made at site by investigator. | Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months | 
| Progression - Free Survival (PFS) (Investigator) | PFS was defined as the time from the first dose of gefitinib study treatment until objective disease progression as defined by RECIST 1.1 (≥20% increase in the sum of the diameters of target lesions from minimum, clinically significant progression in non-target lesions or the presence of a new lesion) or death (by any cause in the absence of progression). Progression is based on measurements made at site by investigator. | Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months | 
| Overall Survival (OS) | OS was defined as the time from first dose of gefitinib study treatment until death by any cause. Patients who had not died at the time of analysis were censored at the last date the patient was known to be alive. | Survival follow up from first dose of gefitinib till death of the patient or till end of study in absence of death. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gefitinib, EGFR TKI, efficacy, Caucasian patients, EGFR mutation positive advanced NSCLC, safety