Phase II Iressa Versus Vinorelbine (INVITE)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Non-Small-Cell Lung Carcinoma

Intervention / Treatment
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* Drug: Gefitinib
* Drug: Vinorelbine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gefitinib|nan|
|Drug: Vinorelbine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare ZD1839 and vinorelbine in terms of progression free survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Locally advanced or metastatic NSCLC., Stage IIIb or Stage IV lung cancer