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
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
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate(ORR; confirmed complete response (CR) or partial response (PR) as per the RECIST 1.1 criteria
Via RECIST 1.1 assessed from start of study treatment until disease progression.The median progression free survival is expected to be about 9.5 months.
No
Prof JY Douillard, MD, PhD
Principal Investigator
Centre R GauducheauBd J Monod44805 St-Herblain France
France: Haute Autorité de Santé Transparency Commission
D791AC00014
NCT01203917
September 2010
April 2014
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