NIPH Clinical Trials Search

UMIN ID: C000000035

Registered date:04/09/2005

A Randomized Phase III trial of chemotherapy alone versus chemotherapy followed by gefitinib in stage IIIB/IV non-small cell lung cancer

Basic Information

Recruitment status Complete: follow-up continuing
Health condition(s) or Problem(s) studiedStage IIIB/IV Non-small cell lung cancer
Date of first enrollment2004/04/01
Target sample size600
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Platinum doublet chemotherapy more than 3 cycles up to 6 cycles. Platinum doublet chemotherapy 3 cycles followed by gefitinib except PD cases.


Primary OutcomeOverall survival
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
GenderMale and Female
Include criteria
Exclude criteriaPregnancy or breast feeding Past history of drug hypersensitivity SVC syndrome Pleural or pericardial effusion that required drainage Active infection Interstitial pneumonia or active lung fibrosis Symptomatic brain metastasis Active concomitant malignancy Uncontrolled diabetes Uncontrolled heart disease

Related Information


public contact
Address Japan
Affiliation West Japan Thoracic Oncology Group (WJTOG) West Japan Thoracic Oncology Group (WJTOG)
scientific contact
Name Toyoaki Hida
Address 1-1 Kanokoden, Chikusa-ku, Nagoya Japan
Affiliation Aichi cancer center hospital Department of Thoracic Oncology