Tarceva. ICORG 08-41
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01721252|
Recruitment Status : Completed
First Posted : November 5, 2012
Last Update Posted : March 30, 2015
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.
|Condition or disease|
|Non-small Cell Lung Cancer|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||200 participants|
|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|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||August 2013|
- 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. ]Routine CT with RECIST/WHO assessment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|