Afatinib vs Gefitinib in 1st Line EGFR Mutation +ve Adenocarcinoma
Research type
Research Study
Full title
LUX-Lung 7: A randomised, open-label Phase IIb Trial of afatinib versus gefitinib as first-line treatment of patients with EGFR mutation positive advanced adenocarcinoma of the lung
IRAS ID
93533
Contact name
Marianne Nicolson
Sponsor organisation
Boehringer Ingelheim
Eudract number
2011-001814-33
Clinicaltrials.gov Identifier
Research summary
LUX-Lung 7 is a randomised, open-label phase IIb trial of afatinib versus gefitinib as first-line treatment of patients with EGFR mutation positive advanced adenocarcinoma of the lung. This study is designed to investigate the efficacy (progression-free survival, disease control rate at 12 months, overall survival, objective response rate, time to objective response, disease control rate at 6 and 9 months, duration of objective response and disease control, time to treatment failure and tumour shrinkage) and safety of afatinib compared to gefitinib as first-line treatment in patients with Stage IIIB (locally advanced and not amenable for a curative intent local radiotherapy) or IV (recurrent or metastatic) adenocarcinoma of the lung who have activating EGFR mutations (Del 19 and/or L8585R). Patients on both arms will continue afatinib or gefitinib once daily treatment in the absence of disease progression or unacceptable treatment-related toxicity, physician decision or patient decision to discontinue study treatment. Eligible patients are who have pathologically confirmed diagnosis of Stage IIIB / IV adenocarcinoma of the lung, documented activating epidermal growth factor receptor mutation (Del19 and/or L858R) with tumour tissues, at least one measurable lesion according to response evaluation criteria in solid tumours version 1.1, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, age >= 18 years, adequate organ function. Patients who have previous anti-cancer treatments for advanced disease, prior treament with EGFR targeting samll molecules or antibodies, active brain metastases, any prohibited concomitant medications for therapy with afatinib or gefitinib and other undesirable medical conditions are not eligible. Patients will be asked to visit investigators every 4 weeks for the assessment of tumour, adverse events, medication dispensation and other assessments such as quality of life questionnaire.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
12/ES/0006
Date of REC Opinion
20 Mar 2012
REC opinion
Further Information Favourable Opinion