Phase II Iressa + Irradiation Followed by Chemo in NSCLC
Phase 2
Completed
- Conditions
- Non-Small Cell Lung Cancer
- Registration Number
- NCT00333294
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
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.
Read More
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.
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To estimate the objective response rate in patients treated with this drug
- Secondary Outcome Measures
Name Time Method Determine the safety and toxicity of this drug in these patients
Trial Locations
- Locations (2)
Research Site
🇫🇷Nantes, France
Research SIte
🇫🇷Paris, France