Trial Details
Trial status:
Recruitment start date:
Boehringer Ingelheim Pharmaceuticals
Chief Investigator:
Martin Forster
Recruitment target:
EudraCT number:
Contact details:
Lay summary:
Deciphering Afatinib Response and Resistance With INtratumour Heterogeneity
Design: DARWIN1 is an open label, multi-centre single arm phase II trial for eligible NSCLC patients with sensitising EGFR mutation or HER2 mutations, who relapse and have multi-region sequencing data of the primary tumour available.
Treatment: All patients receive treatment with afatinib once per day until progression, unacceptable toxicity, intercurrent illness or another reason necessitating withdrawal.

Afatinib is already licensed for the treatment of EGFR TKI-naïve adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations, and is therefore a therapy that could be offered outside of the trial.
Key inclusion/exclusion criteria: Patients must have relapsed NSCLC, have multi-region sequencing data of the primary tumour available and have tumours harbouring a sensitising EGFR mutation or HER2 mutation in at least one biopsy at recurrence, or region of the primary sample. Non-TRACERx patients must have at least two tissue/DNA samples of their disease available. Patients must be willing to have a biopsy of relapsed disease. Patients cannot have had any previous exposure to an EGFR TKI (other than afatinib) or previous chemotherapy or biological therapy in the advanced setting. Patients must not have had anti-cancer therapy within 2 weeks prior to start of trial therapy. Patient must not be currently suitable for radical radiotherapy, or have current/pre-existing interstitial lung disease. Patient must not have significal gastrointestinal abnormalies with diarrhoea as a major symptom.

Duration of recruitment: Recruitment timelines are primarily dependent on the recruitment and subsequent relapse of patients on the TRACERx study.
This trial aims to explore whether patients with clonal dominance of EGFR/HER2 mutation have better outcomes after treatment with afatinib than those with subclonal mutations, among patients in the TRACERx study who have relapsed NSCLC.
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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