Efficacy, Safety, Tolerability of Gefitinib as 1st Line in Caucasian Patients With EGFR Mutation Positive Advanced NSCLC
IFUM
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
1 other identifier
interventional
1,060
13 countries
61
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2010
Longer than P75 for phase_4
61 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 7, 2010
CompletedFirst Posted
Study publicly available on registry
September 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedResults Posted
Study results publicly available
October 14, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedJanuary 2, 2017
November 1, 2016
1.9 years
September 7, 2010
August 5, 2013
November 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR) (Investigator)
% 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.
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 (3)
Disease Control Rate (DCR) (Investigator)
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)
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)
Survival follow up from first dose of gefitinib till death of the patient or till end of study in absence of death.
Other Outcomes (3)
Disease Control Rate (DCR) (Independent Central Review)
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
Objective Response Rate (ORR) (Independent Central Review))
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) (Independent Central Review)
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
Study Arms (1)
1
OTHERgefitinib 250mg tablet
Interventions
250mg tablet oral, once daily until objective disease progression is documented or until other discontinuation criterion is met
Eligibility Criteria
You may qualify if:
- 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 )
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (61)
Research Site
Plovdiv, Bulgaria
Research Site
Sofia, Bulgaria
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Stara Zagora, Bulgaria
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Varna, Bulgaria
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Vratsa, Bulgaria
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Angers, France
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Saint-Herblain, France
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Athens, Greece
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Heraklion, Greece
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Larissa, Greece
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Thessaloniki, Greece
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Budapest, Hungary
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Deszk, Hungary
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Edelény, Hungary
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Győr, Hungary
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Mosdós, Hungary
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Székesfehérvár, Hungary
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Ancona, Italy
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Carpi, Italy
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Livorno, Italy
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Perugia, Italy
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Oslo, Norway
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Stavanger, Norway
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Trondheim, Norway
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Gdansk, Poland
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Krakow, Poland
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Lubin, Poland
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Olsztyn, Poland
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Otwock, Poland
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Szczecin, Poland
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Torun, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Coimbra, Portugal
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Lisbon, Portugal
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Porto, Portugal
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Vila Nova de Gaia, Portugal
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Brasov, Romania
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Bucharest, Romania
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Cluj-Napoca, Romania
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Constanța, Romania
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Lleida, Spain
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Lugo, Spain
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Madrid, Spain
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Majadahonda, Spain
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Málaga, Spain
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Basel, Switzerland
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Chur, Switzerland
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Rapperswil-Jona, Switzerland
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Sursee, Switzerland
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Ankara, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Izmir, Turkey (Türkiye)
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Aberdeen, United Kingdom
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Birmingham, United Kingdom
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Burnley, United Kingdom
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Cambridge, United Kingdom
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Dundee, United Kingdom
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Liverpool, United Kingdom
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Nottingham, United Kingdom
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Wolverhampton, United Kingdom
Related Publications (1)
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.
PMID: 24263064DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Haiyi Jiang
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Haiyi Jiang
AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2010
First Posted
September 17, 2010
Study Start
September 1, 2010
Primary Completion
August 1, 2012
Study Completion
June 1, 2016
Last Updated
January 2, 2017
Results First Posted
October 14, 2013
Record last verified: 2016-11