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OpenTrials
Completed

NCT Number: NCT00333294

Phase II Iressa + Irradiation Followed by Chemo in NSCLC

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Clermont-Ferrand, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gefitinib

Drug

Radiation Therapy

Procedure

Cisplatin

Drug

Vinorelbine

Drug

Primary outcomes

  1. To estimate the objective response rate in patients treated with this drug

Secondary outcomes

  1. Determine the safety and toxicity of this drug in these patients

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2004
Study completion
2006
First posted
Jun 5, 2006
Registry last updated
Dec 19, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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