A Blood Diagnostic test for epidermal growth factor receptor (EGFR) mutations

Not Applicable

• Conditions: EGFR Mutation Blood Test Evaluation in Non Small Cell Lung Cancer; Cancer - Lung - Non small cell

• Registration Number: ACTRN12613000739718
• Lead Sponsor: AstraZeneca Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-07-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 185

Inclusion Criteria

For inclusion in the study subjects should fulfil the following criteria:
1. Provision of informed consent prior to any study specific procedures
2. Stage IIIB or IV adenocarcinoma of the lung
3. Age > 18 years old
4. Have had a lung tissue biopsy that is archived and available for EGFR gene testing or be a candidate for a new biopsy
5. Considered clinically suitable for EGFR TKI therapy or chemotherapy as standard first line treatment
6. WHO or ECOG Performance Status equal or less than 2 and life expectancy is greater than or equal to12 weeks.

Exclusion Criteria

Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
1. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
2. Previous enrolment in the present study
3. Participation in another clinical study with any investigational product/device during the last 3 months
4. Pregnancy or breast feeding (women of child-bearing potential)
5. Prior systemic cytotoxic chemotherapy within 6 months
6. Radiation therapy within 4 weeks prior to provision of consent
7. High risk for poor compliance with therapy or follow-up as assessed by investigator
8. Any evidence of severe or uncontrolled diseases eg, unstable or uncompensated respiratory, cardiac (including arrhythmias), hepatic or renal disease.
9. Significant haemorrhage (>30 mL bleeding/episode in previous 3 months) or haemoptysis (>5 mL fresh blood in previous 4 weeks)
10. History of bleeding diathesis (i.e. disseminated intravascular coagulation (DIC), clotting factor deficiency etc) or long-term anticoagulant therapy (other than anti-platelet therapy and low dose warfarin).
11. Past medical history of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis which required steroid treatment or any evidence of clinically active interstitial lung disease
12. History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within 5 years, unless the patient has been disease free for 2 years and there is a tissue diagnosis of the target lesion
13. Active, uncontrolled infection
14. Previous or current treatment with an EGFR TKI

Study & Design

• Study Type: Interventional
• Study Design: Not specified