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

Study Timeline

• Study Start: 2004-09
• Study Completion: 2006-01
• Study First Submitted: 2006-06-02
• Study First Submitted QC: 2006-06-02
• Study First Posted: 2006-06-05
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-16
• Last Update Posted: 2007-12-19

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.

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.

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