Overview

This trial is active, not recruiting.

Condition caucasian patients with egfr mutation positive advanced nsclc
Treatment gefitinib
Phase phase 4
Target EGFR
Sponsor AstraZeneca
Start date September 2010
End date August 2012
Trial size 1060 participants
Trial identifier NCT01203917, D791AC00014

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
gefitinib 250mg tablet
gefitinib IRESSA™
250mg tablet oral, once daily until objective disease progression is documented or until other discontinuation criterion is met

Primary Outcomes

Measure
Objective Response Rate (ORR) (Investigator)
time frame: 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 Outcomes

Measure
Disease Control Rate (DCR) (Investigator)
time frame: 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)
time frame: 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)
time frame: Survival follow up from first dose of gefitinib till death of the patient or till end of study in absence of death.

Eligibility Criteria

Male or female participants from 18 years up to 130 years old.

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.

Additional Information

Official title 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
Description 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
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.