Trial Details
Trial status:
In follow-up (non-recruiting)
Recruitment start date:
F.Hoffmann-La Roche Ltd
Chief Investigator:
Charles Swanton
Recruitment target:
EudraCT number:
Contact details:
Lay summary:
Deciphering Anti-tumour Response and Resistance With INtratumour Heterogeneity
Design: DARWIN II is a phase II multi-centre non-randomised trial for NSCLC patients to study tumour heterogeneity using genomic analysis. The trial will only be opened in sites participating in the TRACERx study.

Arm 1 patients will receive MPDL3280A (Atezolizumab) for 24 cycles. After completion of treatment, patients will be followed up 3 monthly until progression or for 2 years post the end of treatment. 

Arm 2/Arm 3 patients will receive Vemurafenib (Arm 2) or Alectinib (Arm 3) twice a day until disease progression. For administrative purposes treatment is divided into 28 day cycles. Patients will be seen monthly.

Arm 4 patients will receive Trastuzumab Entamsine on day 1 of a 21 day cycle, and should be treated until disease progression.

For TRACERx patients, follow up will then continue under the TRACERx protocol for as long as TRACERx remains open. For non-TRACERx patients or where TRACERx is closed, patients will revert to routine follow up.

Key inclusion/exclusion criteria: Patients must have multi-region sequencing data of the primary tumour available and must be willing to have a biopsy of relapsed disease. Patients must have the absence of sensitizing EGFR mutation. Non-TRACERx patients must have at least two archival tissue/DNA samples available. Patients must not have a history of other malignancy, previous anti-cancer therapy (within 14 days) or palliative radiotherapy (within 1 week) prior to registration. Patients with pre-exisiting interstitial lung disease or that are suitable for radical radiotherapy are excluded.
Duration of recruitment: Timelines are dependent on the recruitment and subsequent relapse of patients on the TRACERx study – approx. 4 years.
The trial aims to explore whether mutational burden and neo-antigen repertoire predict for improved progression free survival and anti-PDL1 mAb immunotherapy for those patients with stage III/IV NSCLC (patients in whose tumour lacks an actionable mutation).
For those patients with actionable BRAFV600 mutations, HER2 amplification and HER2 IHC2+/3+ or ALK/RET gene fusions this trial aims to assess the role of clonal dominance on the mechanisms of action and response to Vemurafenib, Trastuzumab Emtansine and Alectinib, respectively.

Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
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