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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01721252
• Other study ID #: ICORG 08-41
• Status: Completed
• Phase: N/A
• First received: October 24, 2012
• Last updated: March 27, 2015
• Start date: December 2009

Study information

• Verified date: March 2015
• Source: ICORG- All Ireland Cooperative Oncology Research Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Health Information and Quality Authority
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Ireland	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	Galway University Hospital	Galway
Ireland	Mid-Western Regional Hospital	Limerick
Ireland	Our Lady Of Lourdes Hospital, Drogheda	Louth

Sponsors (1)

Lead Sponsor	Collaborator
ICORG- All Ireland Cooperative Oncology Research Group

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Value of a recently identified proteomic algorithm	Routine CT with RECIST/WHO assessment	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.	No