Tarceva. ICORG 08-41

Cancer Trials Ireland200 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Non-small Cell Lung Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

Cork University Hospital

Cork, Ireland

Beaumont Hospital

Dublin, Ireland

St James Hospital

Dublin, Ireland

The Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital

Dublin, Ireland

Outcomes

Primary Outcomes

Value of a recently identified proteomic algorithm

Routine CT with RECIST/WHO assessment

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.

Data from ClinicalTrials.gov

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