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

September 7, 2010
June 11, 2014
September 2010
August 2012   (final data collection date for primary outcome 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 ] [ 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.
Objective response rate(ORR; confirmed complete response (CR) or partial response (PR) as per the RECIST 1.1 criteria [ 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. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01203917 on ClinicalTrials.gov Archive Site
  • 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.
  • Disease control rate (DCR; CR, PR, stable disease (SD)), Progression-Free Survival (PFS) [ Time Frame: from start of study treatment until disease progression. The median progression free survival is expected to be about 9.5 months. ] [ Designated as safety issue: No ]
  • Safety data (Adverse events, Serious adverse events , incidence of and reason for study drug dose interruptions and discontinuations, laboratory assessments, vital signs) [ Time Frame: from start of treatment until 30 days after discontinuation of study treatment. The median progression free survival is expected to be about 9.5 months. ] [ Designated as safety issue: Yes ]
    The main discontinuation criterion is objective disease progression. Patients who met other discontinuation criteria would discontinue treatment earlier.
  • Overall Survival (OS) [ Time Frame: from start of study treatment during the entire study. Patients will be followed for overall survival for the entire recruitment period (which is expected to be 17 months) and until 6 months after last subject started study treatment. ] [ Designated as safety issue: No ]
  • 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.
Not Provided
 
Efficacy, Safety, Tolerability of Gefitinib as 1st Line in Caucasian Patients With EGFR Mutation Positive Advanced NSCLC
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

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.

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
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Caucasian Patients With EGFR Mutation Positive Advanced NSCLC
Drug: Gefitinib
250mg tablet oral, once daily until objective disease progression is documented or until other discontinuation criterion is met
Other Name: IRESSA™
1
gefitinib 250mg tablet
Intervention: Drug: Gefitinib
Douillard JY, Ostoros G, Cobo M, Ciuleanu T, McCormack R, Webster A, Milenkova T. First-line gefitinib in Caucasian EGFR mutation-positive NSCLC patients: a phase-IV, open-label, single-arm study. Br J Cancer. 2014 Jan 7;110(1):55-62. doi: 10.1038/bjc.2013.721. Epub 2013 Nov 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1060
April 2016
August 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   France,   Greece,   Hungary,   Italy,   Norway,   Poland,   Portugal,   Romania,   Spain,   Switzerland,   Turkey,   United Kingdom
 
NCT01203917
D791AC00014
No
AstraZeneca
AstraZeneca
Not Provided
Study Director: Haiyi Jiang AstraZeneca
AstraZeneca
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP