NCT01721252

Tarceva. ICORG 08-41

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
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Cancer Trials Ireland · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Non-small Cell Lung Cancer

Timeline

• Start date: 2009-12-01
• Primary completion: 2013-08-01
• First posted: 2012-11-05
• Last updated: 2015-03-30

Locations

7 sites across 1 country: Ireland