A randomised, open-label, Phase III study of afatinib vs chemotherapy as first-line treatment for patients with Stage IIIB or IV adenocarcinoma of the lung harbouring an epidermal growth factor receptor (EGFR) activating mutation.
LUX-Lung 6 – Afatinib* vs Cisplatin + Gemcitabine in Asian Patients with Epidermal Growth Factor Receptor Mutation-positive Advanced Non-small Cell Lung Cancer
Adenocarcinoma of the lung
EGFR mutation positive
No prior treatment with chemotherapy for advanced/metastatic disease
No prior treatment with EGFR inhibitors
Eastern Cooperative Oncology Group performance status 0–1
Afatinib 40 mg
Oral once daily
Cisplatin + Gemcitabine
75 mg/m² + 1000 mg/m² Intravenous d1+d8, once every 3 weeks up to 6 cycles
Primary Outcome Measures:
Progression-free survival (PFS), assessed by an independent central radiology review
Secondary Outcome Measures:
Objective response rate
Disease control rate
Overall survival (OS)
Time to and duration of objective response
Duration of disease control
Health-related quality of life (HRQoL)
In the intent-to-treat population, median PFS was 11.0 months for afatinib and 5.6 months for cisplatin/gemcitabine.
In a pre-specified OS analysis by mutation subgroups, patients with del19 mutation treated with afatinib demonstrated ≥1 year OS benefit compared with del19 mutation patients treated with cisplatin/gemcitabine.
In the overall patient population, there was no significant OS (secondary endpoint) benefit of afatinib compared with cisplatin/gemcitabine with a median OS of 23.1 months in the afatinib group compared with 23.5 months in the cisplatin/gemcitabine group (p=0.61).
Compared with cisplatin/gemcitabine, afatinib showed better control of cancer-related dyspnoea, cough and pain.
The most common treatment-related adverse events were diarrhoea, rash/acne and stomatitis/mucositis for afatinib, and vomiting, nausea and neutropenia for cisplatin/gemcitabine.
Afatinib also showed significant improvements in Global Health Status (as an indicator of overall HRQoL).
Afatinib showed improved efficacy and clinical benefit compared with cisplatin/gemcitabine chemotherapy in patients with previously untreated advanced adenocarcinoma of the lung and EGFR mutations. Afatinib was also associated with better control of lung
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Clinicaltrials.gov. https://clinicaltrials.gov/ct2/show/study/NCT01121393 (Accessed: May 16).