Deciphering Afatinib Response and Resistance With INtratumour Heterogeneity (DARWIN1)
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|ClinicalTrials.gov Identifier: NCT02183883|
Recruitment Status : Recruiting
First Posted : July 8, 2014
Last Update Posted : November 7, 2018
To assess if targeting activating EGFR and HER2 mutations in Non-Small Cell Lung Cancer (NSCLC) is more effective when these mutations are truncal dominant mutations (≥50%), as opposed to non-dominant (≥5 to <50%) or low frequency mutations (<5%).
This trial will only be available to patients registered to the TRACERx study (NCT01888601).
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Drug: Afatinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Deciphering Afatinib Response and Resistance With INtratumour Heterogeneity|
|Actual Study Start Date :||December 16, 2016|
|Estimated Primary Completion Date :||November 2023|
|Estimated Study Completion Date :||November 2023|
Afatinib, tablet, 40mg, 30mg, 20mg, OD, taken until progression, unacceptable toxicity, intercurrent illness, patient/clinician decision
40mg, 30mg, 20mg, OD, taken until progression, unacceptable toxicity, intercurrent illness, patient/clinician decision.
EGFR positive mutation patients only: dose escalation to a maximum of 50 mg/day may be considered in patients who tolerate a 40 mg/day dose (i.e. absence of diarrhoea, skin rash, stomatitis, and other adverse reactions with CTCAE Grade > 1) in the first 3 weeks. The dose should not be escalated in any patients with a prior dose reduction. The maximum daily dose for EGFR mutation positive patients is 50 mg.
Other Name: Giotrif
- Progression Free Survival (PFS) [ Time Frame: Up to 60 months ]From date of registration until the date of the last documented progression or date of death from any cause, whichever comes first, assessed up to 60 months.
- Overall survival [ Time Frame: Up to 60 months ]From date of registration until the date of death from any cause assessed up to 60 months.
- Time-to-progression [ Time Frame: Up to 60 months ]From date of registration until the date of the last documented progression assessed up to 60 month.
- Tumour Response [ Time Frame: Up to 60 months ]From date of registration until the date of the last documented response assessed up to 60 months.
- Toxicity [ Time Frame: Up to 60 months ]Adverse events, including any dose reductions, interruptions and modifications from date of registration up until 60 months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02183883
|Contact: Harriet Bellfirstname.lastname@example.org|
|Aberdeen Royal Infirmary (NHS Grampian)||Recruiting|
|Aberdeen, United Kingdom|
|Principal Investigator: Gillian Price|
|Heart of England NHS Foundation Trust||Recruiting|
|Birmingham, United Kingdom|
|Principal Investigator: Shobhit Baijal|
|Beatson West of Scotland Cancer Centre (NHS Greater Glasgow & Clyde)||Recruiting|
|Glasgow, United Kingdom|
|Principal Investigator: Nicola Steele|
|Barnet and Chase Farm Hospitals (Royal Free London NHS Foundation Trust)||Recruiting|
|London Borough Of Barnet, United Kingdom|
|Principal Investigator: Tanya Ahmad|
|University College London Hospitals NHS Foundation Trust||Recruiting|
|London, United Kingdom, NW1 2BU|
|Principal Investigator: Martin Forster|
|Cr Uk & Ucl Ctc||Active, not recruiting|
|London, United Kingdom, W1T 4TJ|
|The Christie NHS Foundation Trust||Recruiting|
|Manchester, United Kingdom|
|Principal Investigator: Matthew Krebs|
|Principal Investigator:||Martin Forster||UCLH|