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

UMIN ID: UMIN000001509

Registered date:16/11/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: relapsed non-small-cell lung cancer
• Date of first enrollment: 2008/01/01
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Single agent chemotherapy with Erlotinib

Outcome(s)

• Primary Outcome: Anti-tumor activity
• Secondary Outcome: Adverse 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 minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Patients 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

• Primary Sponsor: Okayama Lung Cancer Study Group
• Source(s) of Monetary Support: none