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
18 Years
N/A
Both
Non-small Cell Lung Cancer
Trial Information
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
Screening/Baseline
1. Routine blood tests (Haematology and Biochemistry) as per hospital practice
2. Research serum sample for proteomic studies (10ml blood sample)
3. 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.
Inclusion Criteria:
- 18 years of age or older
- Any patient who is suited to receive CT scans as part of his/her routine care
- Ability to understand and the willingness to sign a written informed consent, given
according to ICH/GCP, and national/local regulations. A signed informed consent must
be obtained prior to any study specific procedures
- Planned treatment with erlotinib.
Exclusion Criteria:
- Patients younger than 18 years of age
- Patients not foreseen to receive TarcevaTM treatment
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Value of a recently identified proteomic algorithm
Outcome Description:
Routine CT with RECIST/WHO assessment
Outcome 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.
Safety Issue:
No
Authority:
Ireland: Health Information and Quality Authority
Study ID:
ICORG 08-41
NCT ID:
NCT01721252
Start Date:
December 2009
Completion Date:
Related Keywords:
- Non-Small Cell Lung Cancer
- non-small cell lung cancer
- Erlotinib
- TarcevaTM
- proteomic signature
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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