Iressa 2nd Line Phase III Study in Japan

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

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.

Study Overview

• Status: Completed
• Conditions: Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: Gefitinib or Docetaxel

• Study Type: Interventional
• Enrollment (Anticipated): 484
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • 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
    • Research Site
  • Aichi
    • Nagoya, Aichi, Japan
      • Research Site
    • Okazaki, Aichi, Japan
      • Research Site
  • Aomori
    • Hirosaki, Aomori, Japan
      • Research Site
  • Chiba
    • Kashiwa, Chiba, Japan
      • Research Site
  • Ehime
    • Matsuyama, Ehime, Japan
      • Research Site
  • Hokkaido
    • Asahikawa, Hokkaido, Japan
      • Research Site
    • Sapporo, Hokkaido, Japan
      • Research Site
  • Hyogo
    • Akashi, Hyogo, Japan
      • Research Site
    • Kobe, Hyogo, Japan
      • Research Site
  • Ibaraki
    • Naka-gun, Ibaraki, Japan
      • Research Site
  • Kanagawa
    • Isehara, Kanagawa, Japan
      • Research Site
    • Sagamihara, Kanagawa, Japan
      • Research Site
    • Yokohama, Kanagawa, Japan
      • Research Site
  • Miyagi
    • Sendai, Miyagi, Japan
      • Research Site
  • Nagasaki
    • Omura, Nagasaki, Japan
      • Research Site
  • Oita
    • Beppu, Oita, Japan
      • Research Site
  • Osaka
    • Habikino, Osaka, Japan
      • Research Site
    • Izumisano, Osaka, Japan
      • Research Site
    • Osakasayama, Osaka, Japan
      • Research Site
    • Sakai, Osaka, Japan
      • Research Site
    • Toyonaka, Osaka, Japan
      • Research Site
  • Shizuoka
    • Iwata, Shizuoka, Japan
      • Research Site
    • Sunto-gun, Shizuoka, Japan
      • Research Site
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan
      • Research Site
    • Chuo, Tokyo, Japan
      • Research Site
    • Kiyose, Tokyo, Japan
      • Research Site
    • Minato-ku, Tokyo, Japan
      • Research Site
    • Shinjuku, Tokyo, Japan
      • Research Site
    • Sumida, Tokyo, Japan
      • Research Site
    • Toshima-ku, Tokyo, Japan
      • Research Site
  • Yamaguchi
    • Ube, Yamaguchi, Japan
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Determine the overall survival with these treatments as the primary outcome.

Secondary Outcome Measures

Outcome Measure
Determine the followings as the secondary outcome variables:
- Progression-free survival (PFS)
- Time to treatment failure (TTF)
- Objective tumour response (CR, PR) and the disease control rate (CR, PR, SD [≥12 weeks]) based on the RECIST guidelines
- Lung cancer subscale (LCS)
- QOL according to FACT-L questionnaire
- Frequency and severity of adverse events.
Determine the followings as the exploratory outcome variables:
- Biomarkers related to expression, activation and dimerisation of EGFR and other ErbB family receptors and associated pathways including downstream signalling pathways
- 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.

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: AstraZeneca Japan Medical Director, MD, AstraZeneca

Publications and helpful links

General Publications

• Maruyama R, Nishiwaki Y, Tamura T, Yamamoto N, Tsuboi M, Nakagawa K, Shinkai T, Negoro S, Imamura F, Eguchi K, Takeda K, Inoue A, Tomii K, Harada M, Masuda N, Jiang H, Itoh Y, Ichinose Y, Saijo N, Fukuoka M. Phase III study, V-15-32, of gefitinib versus docetaxel in previously treated Japanese patients with non-small-cell lung cancer. J Clin Oncol. 2008 Sep 10;26(26):4244-52. doi: 10.1200/JCO.2007.15.0185.

Study record dates

Study Major Dates

• Study Start: September 1, 2003
• Study Completion (Actual): November 1, 2006

Study Registration Dates

• First Submitted: November 14, 2005
• First Submitted That Met QC Criteria: November 14, 2005
• First Posted (Estimate): November 15, 2005

Study Record Updates

• Last Update Posted (Estimate): December 18, 2007
• Last Update Submitted That Met QC Criteria: December 14, 2007
• Last Verified: December 1, 2007

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Protein Kinase Inhibitors; Docetaxel; Gefitinib
• Other Study ID Numbers: D791AL00001; V-15-32