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

June 1, 2016 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

216

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • 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, Australia
        • Research Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Research Site
      • Edmonton, Alberta, Canada
        • Research Site
    • British Columbia
      • Kelowna, British Columbia, Canada
        • Research Site
      • Surrey, British Columbia, Canada
        • Research Site
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Research Site
    • New Brunswick
      • Moncton, New Brunswick, Canada
        • Research Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Research Site
    • Ontario
      • Barrie, Ontario, Canada
        • Research Site
      • Hamilton, Ontario, Canada
        • Research Site
      • Kingston, Ontario, Canada
        • Research Site
      • London, Ontario, Canada
        • Research Site
      • Mississauga, Ontario, 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
      • Thunder Bay, Ontario, Canada
        • Research Site
      • Toronto, Ontario, Canada
        • Research Site
  • Czech Republic
      • Nova Ves pod Plesi, Czech Republic
        • Research Site
  • Netherlands
      • Amsterdam, Netherlands
        • Research Site
      • Den Bosch, Netherlands
        • Research Site
      • Den Haag, Netherlands
        • Research Site
      • Eindhoven, Netherlands
        • Research Site
      • Zutphen, Netherlands
        • Research Site
  • United Kingdom
      • Abergavenny, United Kingdom
        • Research Site
      • Birmingham, United Kingdom
        • Research Site
      • Cardiff, United Kingdom
        • Research Site
      • Leeds, United Kingdom
        • Research Site
      • Wolverhampton, United Kingdom
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 130 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gefitinib
ZD1839 + BSC (best supportive care)
Drug: Gefitinib
Placebo Comparator: Placebo
Placebo + BSC (best supportive care)
Other: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To compare Iressa v best supportive care in terms of progression free survival
Time Frame: Progression-free survival
Progression-free survival

Secondary Outcome Measures

Outcome Measure
Time Frame
To compare Iressa v best supportive care in terms of objective tumour response rate
Time Frame: Overall objective tumour response rate (CR and PR) according to the RECIST criteria
Overall objective tumour response rate (CR and PR) according to the RECIST criteria
To compare Iressa v best supportive care in terms of overall survival
Time Frame: Time to death
Time to death
To compare Iressa v best supportive care in terms of quality of life
Time Frame: 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
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
To compare Iressa v best supportive care in terms of tolerability
Time Frame: Adverse event profile (type, frequency and severity of adverse events); laboratory parameters and vital signs
Adverse event profile (type, frequency and severity of adverse events); laboratory parameters and vital signs

Other Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 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
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
To compare gefitinib + BSC versus Placebo + BSC in terms of Health Resource Utilisation
Time Frame: 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.
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.
To compare gefitinib + BSC versus Placebo + BSC in terms of changes in pain and fatigue
Time Frame: Changes in pain and fatigue as measured by the single items from the FACT-L physical well being domain.
Changes in pain and fatigue as measured by the single items from the FACT-L physical well being domain.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: AstraZeneca Iressa Medical Science Director, MD, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

November 25, 2005

First Submitted That Met QC Criteria

November 25, 2005

First Posted (Estimate)

November 29, 2005

Study Record Updates

Last Update Posted (Estimate)

June 2, 2016

Last Update Submitted That Met QC Criteria

June 1, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1839IL/0711
  • D7913C00711

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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