NIPH Clinical Trials Search

UMIN ID: UMIN000002014

Registered date:19/06/2009

Phase III study of gefitinib versus erlotinib in patients with previously treated lung adeno carcinoma

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedPreviously treated lung adeno carcinoma
Date of first enrollment2009/06/01
Target sample size560
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)A: Reference arm Erlotinib monotherapy B: Experimental arm Gefitinib monotherapy


Primary OutcomeProgression free survival
Secondary OutcomeOverall survival, Response rate, disease control rate, Toxicity, Time to treatment failure,

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1)History of obvious and widely distributed interstitial pneumonia or pulmonary fibrosis detected by chest CT 2)History of drug induced interstitial pneumonia 3)History of severe drug allergy 4)History of radiation therapy for mediastinum or lung within 14 days at the time of entry. (Radiation therapy for other parts is not adapted for this exclusion cliteria.) 5)History of poorly controlled pleural effusion, pericardial effusion or ascites necessitating drainage 6)History of active infection 7)History of persistent watery diarrhea 8)History of ileus 9)Patients who are not take in drug orally 10)History of symptomatic brain metastases. 11)History of active double cancer 12)History of poorly controlled cardiac diseases. 13)History of active psychological disease. 14) History of pregnancy or lactation 15) Patients whose participation in the trial is judged to be inappropriate by the attending doctor

Related Information


public contact
Name Shinichiro Nakamura
Address Namba Plaza Bldg.3F 1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN Japan
Telephone 06-6633-7400
Affiliation West Japan Oncology Group WJOG datacenter
scientific contact
Name Yoshiko Urata
Address 13-70 Kitaoji –cho, Akasi-city, Hyogo. Japan
Telephone 078-929-1151
Affiliation Hyogo Cancer Center Thoracic Oncology