LUX-Lung 8, Afatinib versus Erlotinib in Squamous NSCLC
Research type
Research Study
Full title
1200.125, LUX-Lung 8: A randomized, open-label Phase III trial of afatinib versus erlotinib in patients with advanced squamous cell carcinoma of the lung as second-line therapy following first-line platinum-based chemotherapy
IRAS ID
97403
Contact name
Elizabeth Toy
Sponsor organisation
Boehringer Ingelheim
Eudract number
2011-002380-24
Clinicaltrials.gov Identifier
Research summary
This is an open-label Phase III trial in patients with squamous cell carcinoma of the lung. Patients with Non-Small Cell Lung cancer (NSCLC) squamous cell histology represent a population with a large unmet medical need. Chemotherapy choices for these patients is not only restricted from an efficacy standpoint but also limited by the ability of these patients to tolerate these agents. In the second-line setting their choices are mostly restricted to single agents. Although several treatments may have shown limited activity, only docetaxel and Erlotinib are approved. Afatinib is an ideal candidate that needs further evaluation in this setting. Patients will be treated with Afatinib or Erlotinib. The primary objective of the trial is to compare the efficacy of afatinib with erlotinib as second-line treatment for this group of patients, as measured by progression free survival (PFS). The key secondary trial objective is to compare the overall survival (OS) in both treatment groups. In addition other secondary objectives are to compare the Objective Response Rate (ORR), Disease Control Rate (DCR) and tumour shrinkage of afatinib with erlotinib, and the assessment of Health-Related Quality of Life (HRQoL) and safety in both treatment groups. Afatinib has established proof of concept in Squamous Cell Cancer of Head and Neck (SCCHN) and has shown evidence of activity in NSCLC squamous-cell histology. Similar agents have already established randomized Phase II data in NSCLC that supports further exploration of this concept in a direct comparison to erlotinib. Given the large unmet medical need and a desire to provide patients with treatment alternatives that are time and cost efficient the current trial is proposed.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
12/SC/0149
Date of REC Opinion
29 Mar 2012
REC opinion
Favourable Opinion