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Completed

NCT Number: NCT00259064

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

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.

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Key information

Conditions

NSCLC

Age range

18 year–130 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Research Site, Bedford Park, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gefitinib

Drug

Placebo

Other

Primary outcomes

  1. To compare Iressa v best supportive care in terms of progression free survival

    Time frame: Progression-free survival

Secondary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: INSTEP

Important dates

Study start
2004
Primary completion
2007
Study completion
2016
First posted
Nov 29, 2005
Registry last updated
Jun 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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