Tarceva. ICORG 08-41

Non-small Cell Lung Cancer Clinical Trial

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

• NCT number: NCT01721252
• Study type: Observational
• Source: ICORG- All Ireland Cooperative Oncology Research Group
• Status: Completed
• Phase: N/A
• Start date: December 2009