NIPH Clinical Trials Search

UMIN ID: UMIN000001509

Registered date:16/11/2008

Phase II study of erlotinib monotherapy for relapsed patients with non-small-cell lung cancer who do not possess any active EGFR gene mutations

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedrelapsed non-small-cell lung cancer
Date of first enrollment2008/01/01
Target sample size30
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Single agent chemotherapy with Erlotinib


Primary OutcomeAnti-tumor activity
Secondary OutcomeAdverse events, overall survival, progression-free survival, questionnaire about participation in this study, and molecular analysis using tumor samples (MET gene amplification, PTEN expression, K-ras gene mutation, methylation anlaysis for serum MGMT, RARB, p16, DAPK, RASSF1A, and EGFR)

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteriaPatients without adequate tumor samples for assessing EGFR mutation status Those with severe co-morbidity including uncontrollable cardiac, cerebral and infectious disease and diabetes mellitus Those with symptomatic cerebral metastasis Those with active interstitial pneumonia or massive malignant pleural/pericardial effusion Pregnant or lactating women Those previously treated with EGFR-tyrosine kinase inhibitors Those who need to be treated immediately with radiotherapy Patients judged as being in inappropriate condition for this study by physician

Related Information


public contact
Address Japan
Telephone 086-235-7227
Affiliation Okayama Lung Cancer Study Group Coordinating Office Hematology, Oncology, Respiratory Medicine
scientific contact
Name Mitsune Tanimoto
Address 2-5-1 Shikata-cho, Okayama 700-8558 Japan
Affiliation Okayama University Hospital Hematology, Oncology, Respiratory Medicine