None listed
Conditions
Brief summary
This study is exploring whether a blood test might be a feasible additional or alternative diagnostic test to a biopsy in patients with lung cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have stage IIIB or IV adenocarcinoma of the lung. You should have had a lung tissue biopsy that is archived and available for testing, or be a candidate for a new biopsy. Trial details All participants in this study will provide 2 blood samples (one before drug therapy and another taken between 14 to 21 days after drug therapy has commenced) to be tested for the epidermal growth factor receptor (EGFR) mutation using a new test kit. The results of this test will be compared to the EGFR mutation status reported via tissue testing for those patients where this information is available. Knowledge of EGFR gene status (positive or negative) can help guide treatment decisions. Based on these results we aim to determine whether the blood test is a feasible alternative or additional approach to a 'traditional' biopsy in evaluating EGFR mutation status.
Interventions
Participants will provide 2 blood samples during the course of the study for validation of a blood-based test for EGFR mutation.
Blood samples will be collected before drug therapy and another taken between 14 to 21 days after drug therapy has commenced.
Blood samples will be sent to a central laboratory where DNA is extracted and analysed for epidermal growth factor receptor (EGFR) gene mutations.
Sponsors
AstraZeneca Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed