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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01721252

Enrollment

200

Registered

2012-11-05

Start date

2009-12-31

Completion date

Unknown

Last updated

2015-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Keywords

non-small cell lung cancer, Erlotinib, TarcevaTM, proteomic signature

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Ireland

Outcome results