Overview

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