Deciphering Antitumour Response and Resistance With INtratumour Heterogeneity (DARWIN II)
DARWIN II is a multi-arm non-randomised phase II trial, Eligible patient will be those who relapse with stage IIIB/IV NSCLC, and are enrolled in the TRACERx study (clinical trials.gov ref. NCT02183883),
The trial will investigate assess if intra-tumour heterogeneity (clonal vs subclonal actionable mutation) is associated with PFS.
Patients without an actionable mutation will receive MPDL3280A a monoclonal antibody targeting anti-PDL1 in the first line setting.
Patients with BRAFV600 mutations, Her2 Amplification, ALK/RET gene rearrangements will be enrolled into arms treating with vemurafenib, trastuzumab emtansine and alectinib respectively.
DARWIN II will include extensive exploratory biomarker analysis to investigate a number of genomic and immune markers that may predict response to MPDL3280A and help guide future clinical trial design.
|Study start date||2014-12-05|