Clinical trial NCT01721252: Tarceva. ICORG 08-41
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer
Keywords: non-small cell lung cancer
Erlotinib
TarcevaTM
proteomic signature
Lead sponsor: Cancer Trials Ireland
Sponsor class: NETWORK
First posted: 2012-11-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient (18 years of age or older) diagnosed with non-small cell lung cancer at any stage who is to be treated with erlotinib.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Value of a recently identified proteomic algorithm
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: Cork University Hospital
city: Dublin
country: Ireland
facility: Beaumont Hospital
city: Dublin
country: Ireland
facility: St James Hospital
city: Dublin
country: Ireland
facility: The Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital
city: Galway
country: Ireland
facility: Galway University Hospital
city: Limerick
country: Ireland
facility: Mid-Western Regional Hospital
city: Louth
country: Ireland
facility: Our Lady Of Lourdes Hospital, Drogheda
Study officials:
References: