Phase II Iressa Versus Vinorelbine (INVITE)

• Status: Completed
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Gefitinib; Vinblastine; Vinorelbine

Criteria

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

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