Status:
COMPLETED
A Prospective Observational Study Evaluating c-MET Expression and EGFR Gene Mutation Correlation With Erlotinib Response
Lead Sponsor:
Chonnam National University Hospital
Collaborating Sponsors:
Roche Pharma AG
Conditions:
Non-small Cell Lung Cancer Metastatic
Non-small Cell Lung Cancer Recurrent
Eligibility:
All Genders
19-80 years
Brief Summary
1. Trial design: Prospective observational study 2. Target population: 200 NSCLC patients with histologically or cytologically confirmed stage IV or recurrent NSCLC who have progressive disease after ...
Eligibility Criteria
Inclusion
- Informed consent
- 19\~80 year old male or female
- Histologically proven advanced or metastatic NSCLC
- Failed to 1st line chemotherapy
- Tumor tissue for genetic analysis
- Evaluable target lesion by RECIST v1.1
- ECOG performance from 0 to 3
- Expected survival more than 12 weeks
Exclusion
- Previous treatment of EGFR-tyrosine kinase inhibitors
- Severe hypersensitivity to erlotinib
- Residual toxicities (above grade 2) after previous chemotherapy
- Total bilirubin more than 1.5x of upper normal limit Liver function tests more than 2.5x of upper normal limits
Key Trial Info
Start Date :
September 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2017
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT01523340
Start Date
September 1 2011
End Date
November 1 2017
Last Update
August 3 2021
Active Locations (1)
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1
Chonnam National University Hwasun Hospital
Hwasun, South Korea, 58128