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

Phase 2

• Conditions: relapsed non-small-cell lung cancer

• Registration Number: JPRN-UMIN000001509
• Lead Sponsor: Okayama Lung Cancer Study Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-11-16
• Study Completion: 2009-11-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anti-tumor activity

Secondary Outcome Measures

Name	Time	Method
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)