Iressa v BSC (Best Supportive Care) in First Line NSCLC

Study Overview
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Brief Summary
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The purpose of the study is to determine if the addition of Iressa to Best Supportive Care treatment will increase the progression free survival of chemo-naïve, poor performance status patients, with stage IIIB or IV NSCLC.

Official Title
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A Phase II Multicentre Randomised, Parallel Group, Double-Blind, Placebo-Controlled Study of ZD1839 (IRESSATM) (250MG Tablet) Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Chemotherapy-Naive Patients With Advanced (Stage IIIB or IV) Non-Small Cell Lung Cancer (NSCLC) and Poor Performance Status

Conditions
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NSCLC

Intervention / Treatment
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* Drug: Gefitinib
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically confirmed NSCLC NSCLC - locally advanced (Stage IIIB) or metastatic (stage IV) disease, not amenable to curative surgery or radiotherapy Not suitable for chemotherapy WHO Performance status 2 or 3 Exclusion Criteria: Newly diagnosed CNS mets Less than 4 weeks since completion of radiotherapy or persistence of any radiotherapy related toxicity Other co-existing malignancies ALT/AST greater than 5 x upper limit of normal ANC less than 1.0 x 109/L or platelets less than 100 x 109/L

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 130 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gefitinib<br>ZD1839 + BSC (best supportive care) | Drug: Gefitinib<br> <br> |
| Placebo Comparator: Placebo<br>Placebo + BSC (best supportive care) | Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare Iressa v best supportive care in terms of progression free survival |  | Progression-free survival | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare Iressa v best supportive care in terms of objective tumour response rate |  | Overall objective tumour response rate (CR and PR) according to the RECIST criteria | 
| To compare Iressa v best supportive care in terms of overall survival |  | Time to death | 
| To compare Iressa v best supportive care in terms of quality of life |  | Improvement in patient-reported functionality as measured by trial outcome index, comprised of the physical and functional well being sections and LCS of FACT-L and quality of life measured by the FACT-L total score | 
| To compare Iressa v best supportive care in terms of tolerability |  | Adverse event profile (type, frequency and severity of adverse events); laboratory parameters and vital signs |