Iressa 2nd Line Phase III Study in Japan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00252707
Recruitment Status : Completed
First Posted : November 15, 2005
Last Update Posted : December 18, 2007
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Brief Summary:
In this study, among the patients with non-small cell lung cancer, those with metastasis or recurrence and previous treatment with chemotherapy will receive gefitinib or docetaxel, and we will compare the effectiveness and safety of gefitinib with docetaxel.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: Gefitinib or Docetaxel Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 484 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicentre, Randomised, Open-Label, Parallel-Group, Phase III Post-Marketing Clinical Study to Compare the Overall Survival Between Gefitinib and Docetaxel in Patients With Advanced or Metastatic (Stage IIIB/IV), or Recurrent Non-Small Cell Lung Cancer, Who Have Failed One or Two Chemotherapy Regimens
Study Start Date : September 2003
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Primary Outcome Measures :
  1. Determine the overall survival with these treatments as the primary outcome.

Secondary Outcome Measures :
  1. Determine the followings as the secondary outcome variables:
  2. - Progression-free survival (PFS)
  3. - Time to treatment failure (TTF)
  4. - Objective tumour response (CR, PR) and the disease control rate (CR, PR, SD [≥12 weeks]) based on the RECIST guidelines
  5. - Lung cancer subscale (LCS)
  6. - QOL according to FACT-L questionnaire
  7. - Frequency and severity of adverse events.
  8. Determine the followings as the exploratory outcome variables:
  9. - Biomarkers related to expression, activation and dimerisation of EGFR and other ErbB family receptors and associated pathways including downstream signalling pathways
  10. - Biomarkers related to somatic (non-inheritable) mutation analyses of genes of the ErbB family, their signalling pathways and associated pathways which are thought to be influenced by gefitinib in tumour cells.

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • You are "histologically" or "cytologically" confirmed to have recurrent or metastatic NSCLC
  • You have been treated with chemotherapy including platinums for NSCLC.

Exclusion Criteria:

  • You have received treatment for non-small lung cancer within 4 weeks before your participation in this study (except for specific therapies)
  • You have or had any disease of acute lung injury, idiopathic pulmonary fibrosis, pulmonary pneumonia, or pneumoconiosis evident on the X-ray
  • You have or had any disease of radiation pneumonia or drug-induced pneumonia, which requires treatment with corticosteroids

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00252707

Research Site
Nagoya, Aichi, Japan
Research Site
Okazaki, Aichi, Japan
Research Site
Hirosaki, Aomori, Japan
Research Site
Kashiwa, Chiba, Japan
Research Site
Matsuyama, Ehime, Japan
Research Site
Asahikawa, Hokkaido, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Akashi, Hyogo, Japan
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Kobe, Hyogo, Japan
Research Site
Naka-gun, Ibaraki, Japan
Research Site
Isehara, Kanagawa, Japan
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Sagamihara, Kanagawa, Japan
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Yokohama, Kanagawa, Japan
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Sendai, Miyagi, Japan
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Omura, Nagasaki, Japan
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Beppu, Oita, Japan
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Habikino, Osaka, Japan
Research Site
Izumisano, Osaka, Japan
Research Site
Osakasayama, Osaka, Japan
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Sakai, Osaka, Japan
Research Site
Toyonaka, Osaka, Japan
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Iwata, Shizuoka, Japan
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Sunto-gun, Shizuoka, Japan
Research Site
Bunkyo-ku, Tokyo, Japan
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Chuo, Tokyo, Japan
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Kiyose, Tokyo, Japan
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Minato-ku, Tokyo, Japan
Research Site
Shinjuku, Tokyo, Japan
Research Site
Sumida, Tokyo, Japan
Research Site
Toshima-ku, Tokyo, Japan
Research Site
Ube, Yamaguchi, Japan
Research Site
Fukuoka, Japan
Research Site
Gifu, Japan
Research Site
Kanazawa, Japan
Research Site
Kumamoto, Japan
Research Site
Nagasaki, Japan
Research Site
Niigata, Japan
Research Site
Okayama, Japan
Research Site
Osaka, Japan
Research Site
Yamagata, Japan
Sponsors and Collaborators
Study Director: AstraZeneca Japan Medical Director, MD AstraZeneca

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00252707     History of Changes
Other Study ID Numbers: D791AL00001
First Posted: November 15, 2005    Key Record Dates
Last Update Posted: December 18, 2007
Last Verified: December 2007

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors