Phase II Iressa + Irradiation Followed by Chemo in NSCLC

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: June 2, 2006
Last updated: December 16, 2007
Last verified: December 2007

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.

Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: Gefitinib
Procedure: Radiation therapy
Drug: Cisplatin
Drug: Vinorelbine
Phase 2

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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To estimate the objective response rate in patients treated with this drug

Secondary Outcome Measures:
  • Determine the safety and toxicity of this drug in these patients

Estimated Enrollment: 50
Study Start Date: September 2004
Study Completion Date: January 2006

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts 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.
  Contacts and Locations
Please refer to this study by its identifier: NCT00333294

Research Site
Clermont Ferrand, France
Research Site
Grenoble, France
Research Site
Nantes, France
Research SIte
Paris, France
Sponsors and Collaborators
Study Director: AstraZeneca France Medical Director, MD AstraZeneca
  More Information

No publications provided Identifier: NCT00333294     History of Changes
Other Study ID Numbers: 1839IL/0530
Study First Received: June 2, 2006
Last Updated: December 16, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 15, 2014