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Trial Details
Trial status:
Closed
Recruitment start date:
01/11/2011
Funder:
Boehringer Ingelheim Pharmaceuticals
Sponsor:
UCL
Chief Investigator:
Dr Sanjay Popat
Recruitment target:
37
EudraCT number:
2011-003608-19
Contact details:
ctc.timely@ucl.ac.uk
Lay summary:
TIMELY
Trial of afatinib in suspected or confirmed mutant EGFR lung cancer patients unfit for chemotherapy
Description
Design: TIMELY was an open label single arm phase II trial using an irreversible second generation EGFR inhibitor, afatinib. Trial afatinib treatment was given to non-small cell lung cancer (NSCLC) patients who were considered unfit for chemotherapy and harbour a suspected EGFR mutation (adenocarcinoma, ex or never smoker with no EGFR genotyping performed) or confirmed EGFR mutation. Patients were treated until disease progression, unacceptable toxicity or patient/clinician decision to stop. The primary endpoint is progression free survival at 6 months.
Treatment:

Patients received oral afatinib once daily (starting dose of 40mg), administered in cycles of 28 days. Dose reductions to 30mg and 20mg afatinib applied according to drug related toxicity.

Key inclusion/exclusion criteria:

·         Any stage NSCLC patient not suitable for radical treatment who harbour a suspected EGFR mutation or confirmed EGFR mutation.

·         WHO performance status of 0-3.

·         Adequate renal and liver function, serum creatinine clearance ≥ 45 ml/min.

·         No concurrent anticancer treatment.

·         No pre-existing interstitial lung disease.

·         No significant or recent gastrointestinal abnormalities with diarrhoea as a major symptom.

·         No symptomatic heart failure with NYHA classification of 3 or more.

Duration of recruitment: 2 years
Aim
To examine the efficacy and safety of afatinib in suspected or confirmed EGFR mutant NSCLC patients who are considered unfit for chemotherapy.
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
Contact Us
Cancer Research UK & UCL Cancer Trials Centre
University College London
90 Tottenham Court Road
London
W1T 4TJ

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Email:
ctc.enquiries@ucl.ac.uk
Telephone:
+44 (0)20 7679 9898 (General CTC Enquiries)
Fax:
020 7679 9899
University College London, Gower Street, London, WC1E 6BT +44 (0)20 7679 2000

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