Tarceva. ICORG 08-41

Completed

• Conditions: Non-small Cell Lung Cancer

• Registration Number: NCT01721252
• Lead Sponsor: Cancer Trials Ireland

Brief 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.

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2012-10-24
• Study First Submitted QC: 2012-11-01
• Study First Posted: 2012-11-04
• Primary Completion: 2013-08
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-27
• Last Update Posted: 2015-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Value of a recently identified proteomic algorithm	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

Trial Locations

Locations (7)

Beaumont Hospital; 🇮🇪 Dublin, Ireland

Mid-Western Regional Hospital; 🇮🇪 Limerick, Ireland

Galway University Hospital; 🇮🇪 Galway, Ireland

St James Hospital; 🇮🇪 Dublin, Ireland

The Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital; 🇮🇪 Dublin, Ireland

Our Lady Of Lourdes Hospital, Drogheda; 🇮🇪 Louth, Ireland

Cork University Hospital; 🇮🇪 Cork, Ireland