Phase II Iressa + Irradiation Followed by Chemo in NSCLC

AstraZeneca

Status and phase

Completed

Phase 2

Conditions

Non-Small Cell Lung Cancer

Treatments

Drug: Cisplatin

Drug: Vinorelbine

Drug: Gefitinib

Procedure: Radiation therapy

Study type

Interventional

Funder types

Industry

Identifiers

NCT00333294

1839IL/0530

Details and patient eligibility

About

The objective of this study is to determine wether the ZD1839 associated with a radiotherapy, before the beginning of chemotherapy is effective in the treatment of your disease and to evaluate the tolerance of these treatments.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Signed informed consent.
18 to 75 years inclusive.
At least one measurable lesions histologically confirmed inoperable stage III NSCLC.
WHO performance status of 0 to 2 inclusive.
Adequate pulmonary function, pulmonary dose volume histogram less than or equal to 40 %.
Life expectancy of at least 6 months.
Using secure contraceptives precautions.

Exclusion criteria

Any previous anti cancer therapy for NSCLC.
Known severe hypersensitivity to these products
Any evidence of clinically active interstitial lung disease
Other co-existing malignancies, symptomatic metastases.
Abnormal blood test
Weight loss of over 15% in the 3 months before the start of the study.
Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.