Deciphering Antitumour Response and Resistance With INtratumour Heterogeneity (DARWIN II) (NCT02314481)
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 (Zelboraf®; Genentech, Inc/ Daiichi-Sankyo Co.), ado-trastuzumab emtansine (T-DM1, Kadcyla®; Genentech, Inc.) 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.
- Condition: Non-small Cell Lung Cancer
- Phase: II
- Estimated Enrollment: 157
- Start: June 2015
- Estimated Completion: June 2022
- Last verified: December 2014
Last Editorial review: July 29, 2015
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.
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