NCT02314481 (DARWIN II) (Clinical Trial/ Ado-Trastuzumab Emtansine)

Study Title
Deciphering Antitumour Response and Resistance With INtratumour Heterogeneity (DARWIN II) (NCT02314481)

Trial Description
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 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.

This trial is sponsored by University College LondonF. Hoffmann-La Roche. [1]

Study Data

  • Condition: Non-small Cell Lung Cancer
  • Interventions:
  • Phase: II
  • Estimated Enrollment: 157
  • Start: June 2015
  • Estimated Completion: June 2022
  • Last verified: December 2014

Study Schematic

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Last Editorial review: July 29, 2015
Information based on (NIH/NCI) and other sources.

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