Non-Small Cell Lung Cancer
Conditions
Brief summary
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.
Interventions
DRUGGefitinib
PROCEDURERadiation therapy
DRUGCisplatin
DRUGVinorelbine
Sponsors
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To estimate the objective response rate in patients treated with this drug | — |
Secondary
| Measure | Time frame |
|---|---|
| Determine the safety and toxicity of this drug in these patients | — |
Countries
France
Outcome results
None listed