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

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00259064

Acronym

INSTEP

Enrollment

216

Registered

2005-11-29

Start date

2004-09-30

Completion date

2016-04-30

Last updated

2016-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NSCLC

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.

Interventions

DRUGGefitinib

OTHERPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 130 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
To compare Iressa v best supportive care in terms of overall survival	Time to death
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
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
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

Other

Measure	Time frame
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.
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.
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

Countries

Australia, Canada, Czechia, Netherlands, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026