Tarceva. ICORG 08-41
The aim of this study is to determine prospectively the value of a recently identified proteomic signature in identifying those patients with lung cancer, who are likely to benefit from and respond favourably to erlotinib therapy.
This is a prospective study of serum proteomics as a predictor of response to erlotinib therapy.
Non-small Cell Lung Cancer
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Prospective Evaluation of a Proteomic Signature Developed to Identify Patients Likely to Benefit From Erlotinib (TarcevaTM), an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Used in the Treatment of Non-small Cell Lung Cancer|
- Value of a recently identified proteomic algorithm [ Time Frame: Change in CT scans taken at baseline, 2 and 4 months post commencement of therapy and one year after treatment with erlotinib will be analyzed with the emphasis on identification of disease progression. ] [ Designated as safety issue: No ]Routine CT with RECIST/WHO assessment
|Study Start Date:||December 2009|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
- Routine blood tests (Haematology and Biochemistry) as per hospital practice
- Research serum sample for proteomic studies (10ml blood sample)
- Routine pre-treatment CT but with formal RECIST/WHO measurements of tumour size
2 months Post Commencement of Treatment with erlotinib: Routine CT with RECIST/WHO assessment
4 months Post Commencement of Treatment with erlotinib: Routine CT with RECIST/WHO assessment
1 year Post Commencement of Treatment with erlotinib (as per current standard of care): Routine CT with RECIST/WHO assessment
Response Assessment: CT scans at baseline, at 2 and 4 months post commencement of therapy and one year after treatment with erlotinib will be analyzed with the emphasis on identification of disease progression.
Follow Up: Subsequent follow-up as per routine.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01721252
|Cork University Hospital|
|St James Hospital|
|The Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital|
|Galway University Hospital|
|Mid-Western Regional Hospital|
|Our Lady Of Lourdes Hospital, Drogheda|