First Line IRESSA™ Versus Carboplatin/Paclitaxel in Asia

Condition(s) targeted: Non-Small Cell Lung Cancer

Intervention: Gefitinib (Drug); Carboplatin (Drug); Paclitaxel (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Nick Botwood, MD, Study Director, Affiliation: AstraZeneca

The purpose of this study is to compare gefitinib with carboplatin / paclitaxel doublet chemotherapy given as first line treatment in terms of progression free survival in selected NSCLC patients.

Official title: Open Label, Randomised, Parallel Group, Multicentre, Ph III Study To Assess Efficacy, Safety & Tolerability Of Gefitinib (IRESSA™) Versus Carboplatin/Paclitaxel DC As 1st-Line Treatment In Selected Patients With Stage IIIB / IV NSCLC In Asia

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: To compare gefitinib with carboplatin/paclitaxel doublet chemotherapy given as first line treatment in terms of progression free survival.

Secondary outcome:

To compare Iressa v carboplatin/paclitaxel in terms of overall survival

To compare Iressa carboplatin/paclitaxel in terms of objective tumour response rate

To compare the safety and tolerability profile of Iressa v carboplatin/paclitaxel

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Locally advanced Stage IIIB not amenable to local therapy or Stage IV (metastatic)

NSCLC with adenocarcinoma histology.

- Never smokers or light ex-smokers.(ceased smoking at least 15 years before Day 1 of

study treatment and 10 pack-years or fewer)

Exclusion Criteria:

- Had prior chemotherapy, biological (including targeted therapies such as EGFR and

vascular epidermal growth factor (VEGF) inhibitors) or immunological therapy.

- Pre-existing idiopathic pulmonary fibrosis evidence by CT scan at baseline.

Research Site, Beijing, China

Research Site, CHENGDU, China

Research Site, SHANGHAI, China

Research Site, HANGZHOU, China

Research Site, Hong Kong, Hong Kong

Research Site, Yogyakarta, Indonesia

Research Site, Jakarta, Indonesia

Research Site, Solo, Indonesia

Research Site, Surabaya, Indonesia

Research Site, Fukuoka, Japan

Research Site, Kumamoto, Japan

Research Site, Okayama, Japan

Research Site, Osaka, Japan

Research Site, Kuala Lumpur, Malaysia

Research Site, Nilai, Malaysia

Research Site, Penang, Malaysia

Research Site, Petaling Jaya, Malaysia

Research Site, Cebu City, Philippines

Research Site, Manila, Philippines

Research Site, Quezon City, Philippines

Research Site, Singapore, Singapore

Research Site, Changhua, Taiwan

Research Site, Kaohsiung, Taiwan

Research Site, Taipei, Taiwan

Research Site, Tao-Yuan, Taiwan

Research Site, Bangkok, Thailand

Research Site, Chiang Mai, Thailand

Research Site, Khon Kaen, Thailand

Research Site, Songkla, Thailand

Research Site, Nagoya, Aichi, Japan

Research Site, Okazaki, Aichi, Japan

Research Site, KASHIWA, CHIBA, Japan

Research Site, Semarang, Central Java, Indonesia

Research Site, Malang, East Java, Indonesia

Research Site, Matsuyama, Ehime, Japan

Research Site, FUZHOU, FUJIAN, China

Research Site, Guangzhou, Guangdong, China

Research Site, WUHAN, HUBEI, China

Research Site, Sapporo, Hokkaido, Japan

Research Site, Akashi, Hyogo, Japan

Research Site, Kobe, Hyogo, Japan

Research Site, Kanazawa, Ishikawa, Japan

Research Site, NANJING, JIANGSU, China

Research Site, Yokohama, Kanagawa, Japan

Research Site, Dalian, LIAO NING, China

Research Site, Omura, Nagasaki, Japan

Research Site, Izumisano, Osaka, Japan

Research Site, Osakasayama, Osaka, Japan

Research Site, Sakai, Osaka, Japan

Research Site, CHONGQING, SICHUAN, China

Research Site, Kota Kinabalu, Sabah, Malaysia

Research Site, Sunto-gun, Shizuoka, Japan

Research Site, Bunkyo-ku, Tokyo, Japan

Research Site, Koto-ku, Tokyo, Japan

Research Site, Shinjuku, Tokyo, Japan

Research Site, Ube, Yamaguchi, Japan

AstraZeneca Clinical Trial Information - Outside US

Starting date: March 2006
Ending date: July 2009
Last updated: June 12, 2008