DARWIN1
Research type
Research Study
Full title
Deciphering Afatinib Response and Resistance With INtratumour Heterogeneity
IRAS ID
166127
Contact name
Martin Forster
Contact email
Sponsor organisation
University College London
Eudract number
2014-002197-36
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 0 months, 1 days
Research summary
The DARWIN1 trial is a phase II study to examine whether patients with clonal dominance of EGFR/HER2 mutation have better outcomes with afatinib than those with subclonal mutations. Clonal dominance is where the EGFR/HER2 mutation is found throughout the tumour, whereas subclonal mutations are where EGFR/HER2 mutation is present in parts of the tumour.
Only patients registered to the TRACERx study, and whose NSCLC have relapsed with an EGFR/HER2 mutation will be eligible for DARWIN1.
Tissue collected in DARWIN1 will also be compared to tissue collected within the TRACERx study to see how the genetic make-up of the cancer has changed over time, and to see if there are any other genetic changes within the cancer during and after afatinib treatment.
The study will be undertaken throughout the UK at sites participating in the TRACERx study. The target accrual is approximately 40-50 patients. The exact number and recruitment period will be dependent on the number of patients whose cancers recur and are identified with an EGFR/HER2 positive mutation during the course of the TRACERx study.
Each patient will take afatinib daily until disease progression. Clinical assessments will taken place at 2 and 4 weeks and then every 4 weeks thereafter. At disease progression and on stopping afatinib, patients will be followed up monthly until resolution or stabilisation of any adverse events.
REC name
London - Central Research Ethics Committee
REC reference
15/LO/1050
Date of REC Opinion
23 Jul 2015
REC opinion
Further Information Favourable Opinion