Phase II Iressa Versus Vinorelbine (INVITE)

A Randomised, Open Label, Parallel Group, Multi-Centre, Phase II Study of Progression Free Survival Comparing ZD1839 (IRESSA™) (250 MG Tablet) Versus Vinorelbine (30 MG/M2 Infusion) in Chemonaive, Elderly Patients With Locally Advanced (Stage IIIB) or Metastatic (Stage IV) NSCLC

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00256711

Enrollment

192

Registered

2005-11-22

Start date

2004-07-31

Completion date

2006-02-28

Last updated

2009-04-23

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

Conditions

Non-Small-Cell Lung Carcinoma

Keywords

Locally advanced or metastatic NSCLC., Stage IIIb or Stage IV lung cancer

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.

Interventions

DRUGGefitinib

DRUGVinorelbine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

70 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To compare ZD1839 and vinorelbine in terms of progression free survival	—

Secondary

Measure	Time frame
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 objective tumour response rate (complete response and partial response) 6 weekly to progression.	—
To compare ZD1839 and vinorelbine in terms of overall survival (time to death) continuous monitoring	—

Countries

Australia, Brazil, Czechia, France, Germany, Italy, South Africa, South Korea, Taiwan, United Kingdom

Outcome results

None listed

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