Back to resultsIressa 2nd Line Phase III Study in Japan
Primary Purpose
Non-Small Cell Lung Cancer
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Gefitinib or Docetaxel
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer
Eligibility Criteria
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
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Outcomes
Primary Outcome Measures
Determine the overall survival with these treatments as the primary outcome.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00252707
Brief Title
Iressa 2nd Line Phase III Study in Japan
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 Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
484 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Gefitinib or Docetaxel
Primary Outcome Measure Information:
Title
Determine the overall survival with these treatments as the primary outcome.
Secondary Outcome Measure Information:
Title
Determine the followings as the secondary outcome variables:
Title
- Progression-free survival (PFS)
Title
- Time to treatment failure (TTF)
Title
- Objective tumour response (CR, PR) and the disease control rate (CR, PR, SD [≥12 weeks]) based on the RECIST guidelines
Title
- Lung cancer subscale (LCS)
Title
- QOL according to FACT-L questionnaire
Title
- Frequency and severity of adverse events.
Title
Determine the followings as the exploratory outcome variables:
Title
- Biomarkers related to expression, activation and dimerisation of EGFR and other ErbB family receptors and associated pathways including downstream signalling pathways
Title
- 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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Japan Medical Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Research Site
City
Okazaki
State/Province
Aichi
Country
Japan
Facility Name
Research Site
City
Hirosaki
State/Province
Aomori
Country
Japan
Facility Name
Research Site
City
Kashiwa
State/Province
Chiba
Country
Japan
Facility Name
Research Site
City
Matsuyama
State/Province
Ehime
Country
Japan
Facility Name
Research Site
City
Asahikawa
State/Province
Hokkaido
Country
Japan
Facility Name
Research Site
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Research Site
City
Akashi
State/Province
Hyogo
Country
Japan
Facility Name
Research Site
City
Kobe
State/Province
Hyogo
Country
Japan
Facility Name
Research Site
City
Naka-gun
State/Province
Ibaraki
Country
Japan
Facility Name
Research Site
City
Isehara
State/Province
Kanagawa
Country
Japan
Facility Name
Research Site
City
Sagamihara
State/Province
Kanagawa
Country
Japan
Facility Name
Research Site
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Research Site
City
Sendai
State/Province
Miyagi
Country
Japan
Facility Name
Research Site
City
Omura
State/Province
Nagasaki
Country
Japan
Facility Name
Research Site
City
Beppu
State/Province
Oita
Country
Japan
Facility Name
Research Site
City
Habikino
State/Province
Osaka
Country
Japan
Facility Name
Research Site
City
Izumisano
State/Province
Osaka
Country
Japan
Facility Name
Research Site
City
Osakasayama
State/Province
Osaka
Country
Japan
Facility Name
Research Site
City
Sakai
State/Province
Osaka
Country
Japan
Facility Name
Research Site
City
Toyonaka
State/Province
Osaka
Country
Japan
Facility Name
Research Site
City
Iwata
State/Province
Shizuoka
Country
Japan
Facility Name
Research Site
City
Sunto-gun
State/Province
Shizuoka
Country
Japan
Facility Name
Research Site
City
Bunkyo-ku
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Chuo
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Kiyose
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Minato-ku
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Shinjuku
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Sumida
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Toshima-ku
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Ube
State/Province
Yamaguchi
Country
Japan
Facility Name
Research Site
City
Fukuoka
Country
Japan
Facility Name
Research Site
City
Gifu
Country
Japan
Facility Name
Research Site
City
Kanazawa
Country
Japan
Facility Name
Research Site
City
Kumamoto
Country
Japan
Facility Name
Research Site
City
Nagasaki
Country
Japan
Facility Name
Research Site
City
Niigata
Country
Japan
Facility Name
Research Site
City
Okayama
Country
Japan
Facility Name
Research Site
City
Osaka
Country
Japan
Facility Name
Research Site
City
Yamagata
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
18779611
Citation
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.
Results Reference
derived
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Iressa 2nd Line Phase III Study in Japan
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