Phase II Iressa Versus Vinorelbine (INVITE)

Phase 2

Completed

• Conditions: Non-Small-Cell Lung Carcinoma

• Registration Number: NCT00256711
• Lead Sponsor: AstraZeneca

Brief Summary

This is a randomized, open label, parallel group, multi-centre, phase II study of progression free survival, comparing oral ZD1839 (IRESSA™) (250 mg tablet once daily) to vinorelbine 30 mg/m2 infusion on days 1 and 8 of a 21-day cycle) in chemonaïve, elderly patients with locally advanced (stage IIIB) or metastatic (stage IV) non-small cell lung cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2005-11-20
• Study First Submitted QC: 2005-11-20
• Study First Posted: 2005-11-22
• Study Completion: 2006-02
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-22
• Last Update Posted: 2009-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

• Histologically confirmed NSCLC and willing to provide paraffin embedded tumour tissue
• NSCLC - locally advanced (Stage IIIB) or metastatic (stage IV) disease, not amenable to curative surgery or radiotherapy chemonaïve, life expectancy of 12 weeks
• WHO Performance status <= 2

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Exclusion Criteria

• Newly diagnosed CNS metastases
• Less than 4 weeks since completion of radiotherapy or persistence of any radiotherapy related toxicity.
• Hypersensitivity to ZD1839 or intravenous vinorelbine
• Prior treatment with EGFR inhibitors
• Other co-existing malignancies
• ALT/AST >2.5 x ULRR
• ANC < 2.0 x 10^9/L or platelets < 100 x 10^9/L

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To compare ZD1839 and vinorelbine in terms of progression free survival

Secondary Outcome Measures

Name	Time	Method
To compare ZD1839 and vinorelbine in terms of overall objective tumour response rate (complete response and partial response) 6 weekly to progression.
To compare ZD1839 and vinorelbine in terms of pulmonary symptom improvement weekly for 18 weeks.
To compare ZD1839 and vinorelbine in terms of quality of life 3 weekly for 18 weeks then 6 weekly.
To compare ZD1839 and vinorelbine in terms of adverse event profile continuous monitoring.
To compare ZD1839 and vinorelbine in terms of overall survival (time to death) continuous monitoring

Trial Locations

Locations (1)

Research Site; 🇬🇧 Sheffield, United Kingdom