Iressa 2nd Line Phase III Study in Japan

Non-Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00252707
• Other study ID #: D791AL00001
• Secondary ID: V-15-32
• Status: Completed
• Phase: Phase 3
• First received: November 14, 2005
• Last updated: December 14, 2007
• Start date: September 2003
• Est. completion date: November 2006

Study information

• Verified date: December 2007
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 484
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-Small Cell Lung Cancer

Intervention

Drug:
• Gefitinib or Docetaxel

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

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

External Links

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