Iressa v BSC (Best Supportive Care) in First Line NSCLC

NSCLC Clinical Trial

— INSTEP  

Official title:

A Phase II Multicentre Randomised, Parallel Group, Double-Blind, Placebo-Controlled Study of ZD1839 (IRESSATM) (250MG Tablet) Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Chemotherapy-Naive Patients With Advanced (Stage IIIB or IV) Non-Small Cell Lung Cancer (NSCLC) and Poor Performance Status

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00259064
• Other study ID #: 1839IL/0711
• Secondary ID: D7913C00711
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 25, 2005
• Last updated: June 1, 2016
• Start date: September 2004
• Est. completion date: April 2016

Study information

• Verified date: May 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to determine if the addition of Iressa to Best Supportive Care treatment will increase the progression free survival of chemo-naïve, poor performance status patients, with stage IIIB or IV NSCLC.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: April 2016
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 130 Years

Eligibility

Inclusion Criteria:

• Histologically or cytologically confirmed NSCLC

• NSCLC - locally advanced (Stage IIIB) or metastatic (stage IV) disease, not amenable to curative surgery or radiotherapy

• Not suitable for chemotherapy

• WHO Performance status 2 or 3

Exclusion Criteria:

• Newly diagnosed CNS mets

• Less than 4 weeks since completion of radiotherapy or persistence of any radiotherapy related toxicity

• Other co-existing malignancies

• ALT/AST greater than 5 x upper limit of normal

• ANC less than 1.0 x 109/L or platelets less than 100 x 109/L

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• NSCLC

Intervention

Drug:
• Gefitinib

Other:
• Placebo

Locations

Country	Name	City	State
Australia	Research Site	Bedford Park
Australia	Research Site	Chermside
Australia	Research Site	Concord
Australia	Research Site	Melbourne
Australia	Research Site	Newcastle
Australia	Research Site	Prahran
Australia	Research Site	Randwick
Canada	Research Site	Barrie	Ontario
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Edmonton	Alberta
Canada	Research Site	Halifax	Nova Scotia
Canada	Research Site	Hamilton	Ontario
Canada	Research Site	Kelowna	British Columbia
Canada	Research Site	Kingston	Ontario
Canada	Research Site	London	Ontario
Canada	Research Site	Mississauga	Ontario
Canada	Research Site	Moncton	New Brunswick
Canada	Research Site	Newmarket	Ontario
Canada	Research Site	Oshawa	Ontario
Canada	Research Site	Ottawa	Ontario
Canada	Research Site	Sault Ste. Marie	Ontario
Canada	Research Site	Surrey	British Columbia
Canada	Research Site	Thunder Bay	Ontario
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Winnipeg	Manitoba
Czech Republic	Research Site	Nova Ves pod Plesi
Netherlands	Research Site	Amsterdam
Netherlands	Research Site	Den Bosch
Netherlands	Research Site	Den Haag
Netherlands	Research Site	Eindhoven
Netherlands	Research Site	Zutphen
United Kingdom	Research Site	Abergavenny
United Kingdom	Research Site	Birmingham
United Kingdom	Research Site	Cardiff
United Kingdom	Research Site	Leeds
United Kingdom	Research Site	Wolverhampton

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Australia,  Canada,  Czech Republic,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To investigate the correlation of the expression of biomarkers in tumour tissue obtained prior to gefitinib therapy with gefitinib clinical efficacy and to determine a set of biomarkers to enable patient selection for therapy.		Efficacy (objective response rate and progression free survival), toxicity, EGFR signalling pathways markers, RNA expression profile, gene polymorphisms of pre specified germline and tumour genes, DNA methylation, plasma and urine proteomics	Yes
Other	To compare gefitinib + BSC versus Placebo + BSC in terms of Health Resource Utilisation		The use of selected items of resource and concomitant medications including: number of in patient days, number of out patient visits, number of invasive procedures, pallative radiotherapy, concomitant medications.	No
Other	To compare gefitinib + BSC versus Placebo + BSC in terms of changes in pain and fatigue		Changes in pain and fatigue as measured by the single items from the FACT-L physical well being domain.	No
Primary	To compare Iressa v best supportive care in terms of progression free survival		Progression-free survival	No
Secondary	To compare Iressa v best supportive care in terms of objective tumour response rate		Overall objective tumour response rate (CR and PR) according to the RECIST criteria	No
Secondary	To compare Iressa v best supportive care in terms of overall survival		Time to death	No
Secondary	To compare Iressa v best supportive care in terms of quality of life		Improvement in patient-reported functionality as measured by trial outcome index, comprised of the physical and functional well being sections and LCS of FACT-L and quality of life measured by the FACT-L total score	No
Secondary	To compare Iressa v best supportive care in terms of tolerability		Adverse event profile (type, frequency and severity of adverse events); laboratory parameters and vital signs	No

External Links

•   CSR-1839IL-0711.pdf