Phase II Iressa & Carbo/Gem in NSCLC

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2008-06-30

Brief Summary

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The primary objective is to demonstrate in chemotherapy naïve patients with advanced (Stage IIIB or IV) NSCLC and ECOG PS 2 non-inferiority in progression free survival (PFS) for ZD1839 compared to gemcitabine/carboplatin.

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Detailed Description

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Conditions

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Carcinoma, Non-Small-Cell Lung

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Gemcitabine + Carboplatin

Group Type ACTIVE_COMPARATOR

Gemcitabine

Intervention Type DRUG

intravenous injection

Carboplatin

Intervention Type DRUG

intravenous injection

2

Gefitinib

Group Type EXPERIMENTAL

Gefitinib

Intervention Type DRUG

oral tablet

Interventions

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Gefitinib

oral tablet

Intervention Type DRUG

Gemcitabine

intravenous injection

Intervention Type DRUG

Carboplatin

intravenous injection

Intervention Type DRUG

Other Intervention Names

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IRESSA ZD1839 Gemzar CBDCA

Eligibility Criteria

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Inclusion Criteria

* Advanced Non Small cell Lung Cell Lung cancer
* Never received chemotherapy
* Up and about 50% of waking hours

Exclusion Criteria

* Spread of lung cancer to the brain
* Low level of white blood cells
* Radiotherapy within 4 weeks

Patients were entered to this study, initiated in 2004, before the significance of predictive factors such as smoking history, adenocarcinoma histology and mutation status was described.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No