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

Phase 2

Completed

• Conditions: NSCLC
• Interventions: Other: Placebo; Drug: Gefitinib

• Registration Number: NCT00259064
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2005-11-25
• Study First Submitted QC: 2005-11-25
• Study First Posted: 2005-11-29
• Primary Completion: 2007-02
• Study Completion: 2016-04
• Status Verified: 2016-05
• Last Update Submitted: 2016-06-01
• Last Update Posted: 2016-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 216

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo + BSC (best supportive care)
Gefitinib	Gefitinib	ZD1839 + BSC (best supportive care)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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 overall survival	Time to death
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

Trial Locations

Locations (1)

Research Site; 🇬🇧 Wolverhampton, United Kingdom