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, randomized, 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



Randomization 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

CI, confidence interval.


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

CI, confidence interval.


The most common adverse events for afatinib were:

  • Diarrhea
  • Rash/acne


In the LUX-Lung 1 trial, afatinib improved PFS and response rate but not OS compared with placebo in 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: September 2020).

*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.


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Last updated: January 2021