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
2 other identifiers
interventional
484
1 country
40
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 nonsmall-cell-lung-cancer
Started Sep 2003
Shorter than P25 for phase_3 nonsmall-cell-lung-cancer
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
November 14, 2005
CompletedFirst Posted
Study publicly available on registry
November 15, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedDecember 18, 2007
December 1, 2007
November 14, 2005
December 14, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
Determine the overall survival with these treatments as the primary outcome.
Secondary Outcomes (10)
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)
- +5 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- You are "histologically" or "cytologically" confirmed to have recurrent or metastatic NSCLC
- You have been treated with chemotherapy including platinums for NSCLC.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (40)
Research Site
Nagoya, Aichi-ken, Japan
Research Site
Okazaki, Aichi-ken, Japan
Research Site
Hirosaki, Aomori, Japan
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Kashiwa, Chiba, Japan
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Matsuyama, Ehime, Japan
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Fukuoka, Fukuoka, Japan
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Gifu, Gifu, Japan
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Asahikawa, Hokkaido, Japan
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Sapporo, Hokkaido, Japan
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Akashi, Hyōgo, Japan
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Kobe, Hyōgo, Japan
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Naka-gun, Ibaraki, Japan
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Isehara, Kanagawa, Japan
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Sagamihara, Kanagawa, Japan
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Yokohama, Kanagawa, Japan
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Kumamoto, Kumamoto, Japan
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Sendai, Miyagi, Japan
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Nagasaki, Nagasaki, Japan
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Ōmura, Nagasaki, Japan
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Niigata, Niigata, Japan
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Beppu, Oita Prefecture, Japan
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Okayama, Okayama-ken, Japan
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Habikino, Osaka, Japan
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Izumisano, Osaka, Japan
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Osaka, Osaka, Japan
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Sakai, Osaka, Japan
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Sayama, Osaka, Japan
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Toyonaka, Osaka, Japan
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Iwata, Shizuoka, Japan
Research Site
Sunto-gun, Shizuoka, Japan
Research Site
Bunkyo-ku, Tokyo, Japan
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Chūō, Tokyo, Japan
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Kiyose, Tokyo, Japan
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Minato-ku, Tokyo, Japan
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Shinjuku, Tokyo, Japan
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Sumida City, Tokyo, Japan
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Toshima-ku, Tokyo, Japan
Research Site
Yamagata, Yamagata, Japan
Research Site
Ube, Yamaguchi, Japan
Research Site
Kanazawa, Japan
Related Publications (1)
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.
PMID: 18779611DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Japan Medical Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 14, 2005
First Posted
November 15, 2005
Study Start
September 1, 2003
Study Completion
November 1, 2006
Last Updated
December 18, 2007
Record last verified: 2007-12