Iressa vs Placebo as Maintenance Therapy in Locally Advanced NSCLC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

490 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2007-08-31

Brief Summary

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The aim of the study if to determine if Iressa can prolong the period of time without any disease worsening (Time to progression) in patients previously treated with combined therapy such as surgery and chemotherapy with or without radiotherapy or chemotherapy and radiotherapy

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Detailed Description

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Conditions

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Non Small Cell Lung Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Iressa (Gefitinib)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically Confirmed Non Small Cell Lung Cancer.
* Locally advanced disease previously treated with combined therapy (chemotherapy and surgery with or without radiotherapy, or chemotherapy and radiotherapy).
* Chemotherapy with regimens containing cisplatin or carboplatin is mandatory
* Response to combined therapy

Exclusion Criteria

* No previous treatment with ZD1839 or any other EGFR-targeted therapy
* No progressive disease after combined therapy for locally advanced NSCLC
* No presence of metastatic disease
* No other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
* Any unresolved chronic toxicity from previous anticancer therapy.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No