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LUX-Lung 1 clinical trial

Afatinib and Best Supportive Care vs Placebo and Best Supportive Care in Non-Small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib

Phase IIb/III, randomised, double-blind trial of afatinib* plus best supportive care (BSC) vs placebo plus BSC in patients with non-small cell lung cancer after failure of erlotinib or gefitinib.

Trial NCT00656136


Stage IIIB/IV adenocarcinoma of the lung

Progressed after one or two lines of chemotherapy (including one platinum-based regimen) and ≥12 weeks of treatment with erlotinib or gefitinib

Eastern Cooperative Oncology Group performance status of 0–2



Randomisation 2:1

Afatinib 50 mg Oral once daily + BSC
Placebo Oral once daily + BSC


Primary outcome measure:

  • Overall survival (OS)


Secondary outcome measures:

  • Progression-free survival (PFS) assessed by independent central review
  • Objective response rate
  • Duration of response
  • Health-related quality of life



Median OS was 10.8 months with afatinib and 12.0 months with placebo; the difference was not statistically significant.

Hazard ratio = 1.08 95%CI = 0.86–1.35
LUX-Lung 1: figure for overall survival (OS) with afatinib vs placebo


Median PFS was significantly longer with afatinib (3.3 months) than with placebo (1.1 months). Twenty-nine patients (7%) had a confirmed objective response to afatinib by independent review, compared with one partial response in the placebo group.

LUX-Lung 1: figure for progression-free survival (PFS) with afatinib vs placebo


The most common adverse events for afatinib were:

  • Diarrhoea
  • Rash/acne


Although there was no benefit in terms of OS, patients on afatinib showed improvement in PFS and response rate relative to placebo, suggesting that afatinib might be of some benefit to patients with advanced lung adenocarcinoma that has progressed after one or two lines of chemotherapy and ≥12 weeks of treatment with either erlotinib and/or gefitinib.


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Miller VA, et al. Lancet Oncol 2012;13(5):528–538.

2 (Accessed: July 2017).

*Afatinib is approved in more than 80 markets including the EU, Japan, Taiwan, and Canada under the brand name GIOTRIF®, in the US under the brand name GILOTRIF® and in India under the brand name Xovoltib®; for the full list please see here. Registration conditions differ internationally; please refer to locally approved prescribing information.