Phase II Iressa + Irradiation Followed by Chemo in NSCLC

Non-Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00333294
• Other study ID #: 1839IL/0530
• Status: Completed
• Phase: Phase 2
• First received: June 2, 2006
• Last updated: December 16, 2007
• Start date: September 2004
• Est. completion date: January 2006

Study information

• Verified date: December 2007
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-Small Cell Lung Cancer

Intervention

Drug:
• Gefitinib

Procedure:
• Radiation therapy

Drug:
• Cisplatin

• Vinorelbine

Locations

Country	Name	City	State
France	Research Site	Clermont Ferrand
France	Research Site	Grenoble
France	Research Site	Nantes
France	Research SIte	Paris

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To estimate the objective response rate in patients treated with this drug
Secondary	Determine the safety and toxicity of this drug in these patients