None listed
Conditions
Brief summary
This study is evaluating the effect of Afatinib on the anti-tumour immune response in patients with advanced non-small cell lung cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with advanced non-small cell lung cancer (IIIb/IV). You also need to be willing to undergo study blood tests at Sir Charles Gairdner Hospital in Nedlands, Western Australia. Study details All participants in this study will undergo treatment with Afatinib. Afatinib is an oral drug which is known to be effective in treating some types of lung cancer, particularly those with a mutation in EGFR. The purpose of this research study is to determine how Afatinib affects the cells of the immune system during treatment for lung cancer. There is now evidence to suggest that some cancer treatment drugs may help the immune system to attack cancer cells. If this is the case, it might be possible to develop better cancer treatments by combining them with drugs that stimulate the immune system further. However, it is important to understand exactly how different drugs affect the immune system before deciding which combinations might work well together. Treatment with Afatinib is a once daily tablet, divided into 6 week courses. Treatment will continue while it is of benefit to the patient, and will be stopped for safety reasons or if consent is withdrawn. Research blood samples will be taken at baseline, after 3 weeks and 6 weeks on treatment, and a final one 28 days after last dose of Afatinib. The research bloods will be used to characterise and measure the numbers of different immune cells in the blood, and how well they are reacting against the cancer. Routine blood tests will be required every 6 weeks while on Afatinib to monitor the safety of treatment as is standard for all patients having cancer treatment. Research bloods can be taken with routine bloods at the appropriate time points. A CT scan will be performed at baseline, at 6 weeks and 12 weeks after starting treatment and thereafter at 12-week intervals. A clinic visit is required at baseline, 3 weeks after starting treatment, and then on the first day of each course. Approximately 20 people at Sir Charles Gairdner Hospital only will participate in this study.
Interventions
Afatinib (BIBW 2992) 40 mg per day, oral.
The appropriate number of afatinib tablets for 3 - 6 weeks of treatment will be provided to patients to be self administered at home. Patients will be asked to bring remaining trial medication at the end of each dosing period to the investigator site for a compliance check.
Patients remain on afatinib until progression, toxicity, patient wishes or clinician judgement mandate removal from study.
This is not primarily an efficacy study. It is a pilot t
Afatinib (BIBW 2992) 40 mg per day, oral. The appropriate number of afatinib tablets for 3 - 6 weeks of treatment will be provided to patients to be self administered at home. Patients will be asked to bring remaining trial medication at the end of each dosing period to the investigator site for a compliance check. Patients remain on afatinib until progression, toxicity, patient wishes or clinician judgement mandate removal from study. This is not primarily an efficacy study. It is a pilot translational study examining the effect of afatinib on the anti-tumour immune response in patients with advanced NSCLC.
Sponsors
Sir Charles Gairdner Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with a diagnosis of advanced NSCLC (IIIb/IV) with either: * Documented EGFR mutation and any line of therapy (including first-line), or * Patients satisfying the Jackman criteria of acquired resistance to an EGFR TKI. 2. ECOG PS 0-2 3. Willingness to undergo study blood tests at SCGH 4. Adequate organ function at baseline 5. Written informed consent
Exclusion criteria
1. Unable or unwilling to undergo study blood tests at SCGH 2. Concurrent chemotherapy 3. Chemotherapy within 3 weeks of study entry 4. Significant or recent acute gastrointestinal disorders with diarrhoea as a major symptom 5. History of clinically significant cardiac disease 6. Known autoimmune disease
Outcome results
None listed