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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


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Caucasian Patients With EGFR Mutation Positive Advanced NSCLC

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate(ORR; confirmed complete response (CR) or partial response (PR) as per the RECIST 1.1 criteria

Outcome Time Frame:

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.

Safety Issue:

No

Principal Investigator

Prof JY Douillard, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre R GauducheauBd J Monod44805 St-Herblain France

Authority:

France: Haute Autorité de Santé Transparency Commission

Study ID:

D791AC00014

NCT ID:

NCT01203917

Start Date:

September 2010

Completion Date:

April 2014

Related Keywords:

  • Caucasian Patients With EGFR Mutation Positive Advanced NSCLC
  • Gefitinib
  • EGFR TKI
  • efficacy
  • Caucasian patients
  • EGFR mutation positive advanced NSCLC
  • safety
  • Carcinoma, Non-Small-Cell Lung

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