A diagnostic Study of European and Japanese advanced NSCLC patients to evaluate suitable sample types for EGFR testing: The ASSESS Study

Completed

Conditions: lung cancer
10027656
10029107

Registration Number: NL-OMON38725

Lead Sponsor: Astra Zeneca

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 120

Inclusion Criteria

- Provision of written informed consent.
- Patients aged 18 years and older from European countries and patients aged 20 years and - older for patients from Japan.
- Histological or cytological confirmed locally advanced NSCLC (stage IIIA/B) not suitable for curative treatment or metastatic (stage IV) NSCLC.
- Newly diagnosed patients with locally advanced and/or metastatic NSCLC who are systemic treatment Naïve (i.e. no chemotherapy or EGFR-TKI) or patients with recurrent disease who have previously received adjuvant chemotherapy (not including EGFR-TKI).
- Provision of diagnostic cancer tissue or cytology sample upon inclusion (surgical specimen, biopsy sample, or cytology sample is acceptable).
- Provision of a routine blood (plasma) sample.

Exclusion Criteria

- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
- Previous enrolment in the present study
- As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
- Evidence of any other significant clinical disorder or laboratory finding that made it undesirable for the patient to participate in the study.
- Pregnancy or breast-feeding

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The study will establish whether blood (plasma) is a suitable sample type for<br /><br>reliably determining the EGFR mutation status of patients with NSCLC compared<br /><br>with cytology/tumour tissue.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>In addition the study will also collect information about NSCLC, result of the<br /><br>EGFR mutation test, how the EGFR mutation test is performed in the laboratory,<br /><br>and what effect the EGFR mutation test result has on the choice of drugs used<br /><br>to treat NSCLC. </p><br>