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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01203917
First received: September 7, 2010
Last updated: June 11, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Caucasian Patients With EGFR Mutation Positive Advanced NSCLC
Drug: Gefitinib
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    % 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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • 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. ] [ Designated as safety issue: Yes ]
    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.


Other Outcome Measures:
  • Disease Control Rate (DCR) (Independent Central Review) [ 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 ] [ Designated as safety issue: No ]
    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 of scans by central review.

  • Objective Response Rate (ORR) (Independent Central Review)) [ 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 ] [ Designated as safety issue: No ]
    % 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 of scans by central review.

  • Progression - Free Survival (PFS) (Independent Central Review) [ 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 ] [ Designated as safety issue: Yes ]
    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 of scans by central review.


Enrollment: 1060
Study Start Date: September 2010
Estimated Study Completion Date: April 2016
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
gefitinib 250mg tablet
Drug: Gefitinib
250mg tablet oral, once daily until objective disease progression is documented or until other discontinuation criterion is met
Other Name: IRESSA™

Detailed 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01203917

  Hide Study Locations
Locations
Bulgaria
Research Site
Plovdiv, Bulgaria
Research Site
Sofia, Bulgaria
Research Site
Stara Zagora, Bulgaria
Research Site
Varna, Bulgaria
Research Site
Vratza, Bulgaria
France
Research Site
ANGERS Cedex 9, France
Research Site
Saint Herblain, France
Greece
Research Site
Athens, Greece
Research Site
Heraklion, Greece
Research Site
Larissa, Greece
Research Site
Thessaloniki, Greece
Hungary
Research Site
Budapest, Hungary
Research Site
Deszk, Hungary
Research Site
Edelény, Hungary
Research Site
Győr, Hungary
Research Site
Mosdós, Hungary
Research Site
Székesfehérvár, Hungary
Italy
Research Site
Ancona, Italy
Research Site
Carpi, Italy
Research Site
Livorno, Italy
Research Site
Perugia, Italy
Norway
Research Site
Oslo, Norway
Research Site
Stavanger, Norway
Research Site
Trondheim, Norway
Poland
Research Site
Gdańsk, Poland
Research Site
Kraków, Poland
Research Site
Lubin, Poland
Research Site
Olsztyn, Poland
Research Site
Otwock, Poland
Research Site
Szczecin, Poland
Research Site
Toruń, Poland
Research Site
Warszawa, Poland
Research Site
Wrocław, Poland
Portugal
Research Site
Coimbra, Portugal
Research Site
Lisboa, Portugal
Research Site
Porto, Portugal
Research Site
Vila Nova de Gaia, Portugal
Romania
Research Site
Brasov, Romania
Research Site
Bucharest, Romania
Research Site
Bucuresti, Romania
Research Site
Cluj Napoca, Romania
Research Site
Constanta, Romania
Spain
Research Site
Lugo, Spain
Research Site
Lérida, Spain
Research Site
Madrid, Spain
Research Site
Majadahonda, Spain
Research Site
Málaga, Spain
Switzerland
Research Site
Basel, Switzerland
Research Site
Chur, Switzerland
Research Site
Rapperswil-Jona, Switzerland
Research Site
Sursee, Switzerland
Turkey
Research Site
Ankara, Turkey
Research Site
Istanbul, Turkey
Research Site
Izmir, Turkey
United Kingdom
Research Site
Aberdeen, United Kingdom
Research Site
Birmingham, United Kingdom
Research Site
Burnley, United Kingdom
Research Site
Cambridge, United Kingdom
Research Site
Dundee, United Kingdom
Research Site
Liverpool, United Kingdom
Research Site
Nottingham, United Kingdom
Research Site
Wolverhampton, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Haiyi Jiang AstraZeneca
  More Information

Additional Information:
No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01203917     History of Changes
Other Study ID Numbers: D791AC00014
Study First Received: September 7, 2010
Results First Received: August 5, 2013
Last Updated: June 11, 2014
Health Authority: France: Haute Autorité de Santé Transparency Commission
Greece: National Organization of Medicines
Italy: The Italian Medicines Agency
Hungary: National Institute of Pharmacy
Norway: Norwegian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: National Pharmacy and Medicines Institute
Romania: National Medicines Agency
Spain: Spanish Agency of Medicines
Switzerland: Swissmedic
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Republic of Bulgaria: Bulgarian Drug Agency

Keywords provided by AstraZeneca:
Gefitinib
EGFR TKI
efficacy
Caucasian patients
EGFR mutation positive advanced NSCLC
safety

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gefitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014