A Phase II Open-Label Multicentre Study Of The Efficacy Of ZD1839 (IRESSA™) In Combination With Irradiation Followed By Chemotherapy In Patients With Inoperable Stage III Non Small Cell Lung Cancer
Phase 2
18 Years
75 Years
18 Years
75 Years
Not Enrolling
Both
Non-Small Cell Lung Cancer
Both
Non-Small Cell Lung Cancer
Trial Information
A Phase II Open-Label Multicentre Study Of The Efficacy Of ZD1839 (IRESSA™) In Combination With Irradiation Followed By Chemotherapy In Patients With Inoperable Stage III Non Small Cell Lung Cancer
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To estimate the objective response rate in patients treated with this drug
Principal Investigator
AstraZeneca France Medical Director, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
1839IL/0530
NCT ID:
NCT00333294
Start Date:
September 2004
Completion Date:
January 2006
Related Keywords:
- Non-Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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