Phase II Iressa & Carbo/Gem in NSCLC

AstraZeneca38 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

GefitinibDRUG

oral tablet

GemcitabineDRUG

intravenous injection

CarboplatinDRUG

intravenous injection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Research Site

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

Progression Free Survival (PFS)

Interval between date of randomization and earliest date of objective disease progression per RECIST criteria or death due to any cause in the absence of progression

Time frame: Date of randomization to earliest date of objective disease progression

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.