TIMELY
Research type
Research Study
Full title
Trial of afatinib (BIBW 2992) in suspected or confirmed mutant EGFR lung cancer patients unfit for chemotherapy
IRAS ID
86839
Contact name
Sanjay Popat
Sponsor organisation
University College London
Eudract number
2011-003608-19
Clinicaltrials.gov Identifier
Research summary
The TIMELY trial is a phase II study to examine the efficacy and safety of using an irreversible EGFR inhibitor drug called BIBW 2992, also known as Afatanib, to treat patients with NSCLC adenocarcinoma who are considered unfit for chemotherapy, harbour suspected Epidermal Growth Factor Receptor (EGFR) mutation (either EGFR genotype unknown due to no tissue suitable for genotyping or failed genotype) and who have never smoked or are ex-light smokers), with the aim of improving patient outcomes. The study will be undertaken throughout the UK at approximately 30 sites. The target accrual is 37 patients with an anticipated recruitment period of 18-24 months. For regulatory purposes the end of trial will be 12 months after the last patient has been recruited at which point the 'declaration of end of trial' form will be submitted as required to the regulatory authority and the ethical committee. The study drug BIBW 2992 will be administered only to eligible patients under the supervision of the site investigator or delegated co-investigator. Patients will take 40mg of BIBW 2992 once daily until disease progression, toxicity, clinician/patient decision to stop. For administrative purposes, treatment is divided into cycles of 28 days. Patients will be assessed regularly while taking the study drug as follows: - Fortnightly for the first 2 cycles, monthly for 12 months and 2-monthly thereafter. - Patients who discontinue taking the study drug will be assessed every 2 months for follow-up during the first 12 months from start of treatment and then 3 monthly until death/end of trial. Patients will undergo examinations at each hospital visit as per protocol to monitor safety and assess progression. There is also a translational aspect to the study which involves collecting tissue, blood and urine samples from the patients for analysis.
REC name
Scotland B REC
REC reference
11/SS/0092
Date of REC Opinion
16 Dec 2011
REC opinion
Further Information Favourable Opinion