Clinical trial NCT00252707: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-11-15
Enrollment: 484
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Determine the overall survival with these treatments as the primary outcome.
Secondary outcomes:
measure: Determine the followings as the secondary outcome variables:
measure: - Progression-free survival (PFS)
measure: - Time to treatment failure (TTF)
measure: - Objective tumour response (CR, PR) and the disease control rate (CR, PR, SD [≥12 weeks]) based on the RECIST guidelines
measure: - Lung cancer subscale (LCS)
measure: - QOL according to FACT-L questionnaire
measure: - Frequency and severity of adverse events.
measure: Determine the followings as the exploratory outcome variables:
measure: - Biomarkers related to expression, activation and dimerisation of EGFR and other ErbB family receptors and associated pathways including downstream signalling pathways
measure: - 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.
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Research Site
state: Aichi
city: Okazaki
country: Japan
facility: Research Site
state: Aichi
city: Hirosaki
country: Japan
facility: Research Site
state: Aomori
city: Kashiwa
country: Japan
facility: Research Site
state: Chiba
city: Matsuyama
country: Japan
facility: Research Site
state: Ehime
city: Asahikawa
country: Japan
facility: Research Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Research Site
state: Hokkaido
city: Akashi
country: Japan
facility: Research Site
state: Hyogo
city: Kobe
country: Japan
facility: Research Site
state: Hyogo
city: Naka-gun
country: Japan
facility: Research Site
state: Ibaraki
city: Isehara
country: Japan
facility: Research Site
state: Kanagawa
city: Sagamihara
country: Japan
facility: Research Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Research Site
state: Kanagawa
city: Sendai
country: Japan
facility: Research Site
state: Miyagi
city: Omura
country: Japan
facility: Research Site
state: Nagasaki
city: Beppu
country: Japan
facility: Research Site
state: Oita
city: Habikino
country: Japan
facility: Research Site
state: Osaka
city: Izumisano
country: Japan
facility: Research Site
state: Osaka
city: Osakasayama
country: Japan
facility: Research Site
state: Osaka
city: Sakai
country: Japan
facility: Research Site
state: Osaka
city: Toyonaka
country: Japan
facility: Research Site
state: Osaka
city: Iwata
country: Japan
facility: Research Site
state: Shizuoka
city: Sunto-gun
country: Japan
facility: Research Site
state: Shizuoka
city: Bunkyo-ku
country: Japan
facility: Research Site
state: Tokyo
city: Chuo
country: Japan
facility: Research Site
state: Tokyo
city: Kiyose
country: Japan
facility: Research Site
state: Tokyo
city: Minato-ku
country: Japan
facility: Research Site
state: Tokyo
city: Shinjuku
country: Japan
facility: Research Site
state: Tokyo
city: Sumida
country: Japan
facility: Research Site
state: Tokyo
city: Toshima-ku
country: Japan
facility: Research Site
state: Tokyo
city: Ube
country: Japan
facility: Research Site
state: Yamaguchi
city: Fukuoka
country: Japan
facility: Research Site
city: Gifu
country: Japan
facility: Research Site
city: Kanazawa
country: Japan
facility: Research Site
city: Kumamoto
country: Japan
facility: Research Site
city: Nagasaki
country: Japan
facility: Research Site
city: Niigata
country: Japan
facility: Research Site
city: Okayama
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Yamagata
country: Japan
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Japan Medical Director, MD
role: STUDY_DIRECTOR
References:
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.