Clinical trial NCT01203917: Efficacy, Safety, Tolerability of Gefitinib as 1st Line in Caucasian Patients With EGFR Mutation Positive Advanced NSCLC
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Caucasian Patients With EGFR Mutation Positive Advanced NSCLC
Keywords: Gefitinib
EGFR TKI
efficacy
Caucasian patients
EGFR mutation positive advanced NSCLC
safety
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-09-17
Enrollment: 1060
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Objective Response Rate (ORR) (Investigator)
timeFrame: 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:
measure: Disease Control Rate (DCR) (Investigator)
timeFrame: 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
measure: Progression - Free Survival (PFS) (Investigator)
timeFrame: 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
measure: Overall Survival (OS)
timeFrame: Survival follow up from first dose of gefitinib till death of the patient or till end of study in absence of death.
Other outcomes:
measure: Disease Control Rate (DCR) (Independent Central Review)
timeFrame: 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
measure: Objective Response Rate (ORR) (Independent Central Review))
timeFrame: 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
measure: Progression - Free Survival (PFS) (Independent Central Review)
timeFrame: 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
Locations:
city: Plovdiv
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Stara Zagora
country: Bulgaria
facility: Research Site
city: Varna
country: Bulgaria
facility: Research Site
city: Vratza
country: Bulgaria
facility: Research Site
city: ANGERS Cedex 9
country: France
facility: Research Site
city: Saint Herblain Cedex
country: France
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Heraklion
country: Greece
facility: Research Site
city: Larissa
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Deszk
country: Hungary
facility: Research Site
city: Edelény
country: Hungary
facility: Research Site
city: Győr
country: Hungary
facility: Research Site
city: Mosdós
country: Hungary
facility: Research Site
city: Székesfehérvár
country: Hungary
facility: Research Site
city: Ancona
country: Italy
facility: Research Site
city: Carpi
country: Italy
facility: Research Site
city: Livorno
country: Italy
facility: Research Site
city: Perugia
country: Italy
facility: Research Site
city: Oslo
country: Norway
facility: Research Site
city: Stavanger
country: Norway
facility: Research Site
city: Trondheim
country: Norway
facility: Research Site
city: Gdańsk
country: Poland
facility: Research Site
city: Kraków
country: Poland
facility: Research Site
city: Lubin
country: Poland
facility: Research Site
city: Olsztyn
country: Poland
facility: Research Site
city: Otwock
country: Poland
facility: Research Site
city: Szczecin
country: Poland
facility: Research Site
city: Toruń
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Wrocław
country: Poland
facility: Research Site
city: Coimbra
country: Portugal
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Porto
country: Portugal
facility: Research Site
city: Vila Nova de Gaia
country: Portugal
facility: Research Site
city: Brasov
country: Romania
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site
city: Cluj Napoca
country: Romania
facility: Research Site
city: Constanta
country: Romania
facility: Research Site
city: Lugo
country: Spain
facility: Research Site
city: Lérida
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Majadahonda
country: Spain
facility: Research Site
city: Málaga
country: Spain
facility: Research Site
city: Basel
country: Switzerland
facility: Research Site
city: Chur
country: Switzerland
facility: Research Site
city: Rapperswil-Jona
country: Switzerland
facility: Research Site
city: Sursee
country: Switzerland
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Izmir
country: Turkey
facility: Research Site
city: Aberdeen
country: United Kingdom
facility: Research Site
city: Birmingham
country: United Kingdom
facility: Research Site
city: Burnley
country: United Kingdom
facility: Research Site
city: Cambridge
country: United Kingdom
facility: Research Site
city: Dundee
country: United Kingdom
facility: Research Site
city: Liverpool
country: United Kingdom
facility: Research Site
city: Nottingham
country: United Kingdom
facility: Research Site
city: Wolverhampton
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Haiyi Jiang
role: STUDY_DIRECTOR
References:
citation: 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.