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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00259064
Recruitment Status : Completed
First Posted : November 29, 2005
Last Update Posted : June 2, 2016
Information provided by (Responsible Party):

Brief 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.

Condition or disease Intervention/treatment Phase
NSCLC Drug: Gefitinib Other: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : September 2004
Actual Primary Completion Date : February 2007
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Gefitinib

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

Primary Outcome Measures :
  1. To compare Iressa v best supportive care in terms of progression free survival [ Time Frame: Progression-free survival ]

Secondary Outcome Measures :
  1. 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 ]
  2. To compare Iressa v best supportive care in terms of overall survival [ Time Frame: Time to death ]
  3. 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 ]
  4. 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 ]

Other Outcome Measures:
  1. 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 ]
  2. 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. ]
  3. 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. ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00259064

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Research Site
Bedford Park, Australia
Research Site
Chermside, Australia
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Concord, Australia
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Melbourne, Australia
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Newcastle, Australia
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Prahran, Australia
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Randwick, Australia
Canada, Alberta
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
Canada, British Columbia
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Kelowna, British Columbia, Canada
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Surrey, British Columbia, Canada
Canada, Manitoba
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Winnipeg, Manitoba, Canada
Canada, New Brunswick
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Moncton, New Brunswick, Canada
Canada, Nova Scotia
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Halifax, Nova Scotia, Canada
Canada, Ontario
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Barrie, Ontario, Canada
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Hamilton, Ontario, Canada
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Kingston, Ontario, Canada
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London, Ontario, Canada
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Mississauga, Ontario, Canada
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Newmarket, Ontario, Canada
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Oshawa, Ontario, Canada
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Ottawa, Ontario, Canada
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Sault Ste. Marie, Ontario, Canada
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Thunder Bay, Ontario, Canada
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Toronto, Ontario, Canada
Czech Republic
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Nova Ves pod Plesi, Czech Republic
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Amsterdam, Netherlands
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Den Bosch, Netherlands
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Den Haag, Netherlands
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Eindhoven, Netherlands
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Zutphen, Netherlands
United Kingdom
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Abergavenny, United Kingdom
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Birmingham, United Kingdom
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Cardiff, United Kingdom
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Leeds, United Kingdom
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Wolverhampton, United Kingdom
Sponsors and Collaborators
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Study Director: AstraZeneca Iressa Medical Science Director, MD AstraZeneca

Additional Information:
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Responsible Party: AstraZeneca Identifier: NCT00259064    
Other Study ID Numbers: 1839IL/0711
First Posted: November 29, 2005    Key Record Dates
Last Update Posted: June 2, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action