LUX-Lung 7 clinical trials

A Phase IIb Trial of Afatinib vs Gefitinib for the Treatment of First-Line Epidermal Growth Factor Receptor Mutation-Positive Adenocarcinoma of the Lung

A randomized, open-label, Phase IIb trial of afatinib* vs gefitinib as first-line treatment of patients with common epidermal growth factor receptor (EGFR) mutations (del19/L858R) and advanced adenocarcinoma of the lung.

Trial NCT01466660


  • Stage IIIB/IV lung adenocarcinoma
  • Positive for common EGFR mutations (del19/L858R)
  • No prior chemotherapy for non-small cell lung cancer (NSCLC)
  • No prior treatment with EGFR inhibitors
  • Stable brain metastases at baseline permitted
  • Eastern Cooperative Oncology Group  performance status of 0–1



Randomization 1:1

Afatinib 40 mg Oral once daily
Gefitinib 250 mg Oral once daily


Primary outcome measures:

  • Progression-free survival (PFS), assessed by independent central review
  • Time-to-treatment failure (TTF)
  • Overall survival (OS)

Secondary outcome measures:

  • Objective response rate (ORR)
  • Time to and duration of objective response
  • Duration of disease control
  • Tumor shrinkage
  • Health-related quality of life (HRQoL)



Afatinib significantly improved PFS of patients with EGFR mutation-positive NSCLC relative to gefitinib (hazard ratio [HR]=0.73 [95% confidence interval [CI]: 0.57–0.95], p=0.0165). Risk of progression was reduced by 27%. Results were consistent across subgroups including EGFR mutation subgroups.

Hazard ratio = 0.73 95% CI = 0.57–0.95
LUX-Lung 7: figure for progression-free survival (PFS) with afatinib vs gefitinib

CI, confidence interval.



Afatinib treatment was associated with a significant (p=0.0073) improvement in TTF (time from randomization to discontinuation for any reason). Risk of treatment failure was reduced by 27%. The improvement in efficacy was observed in both del19 and L858R populations.

Hazard ratio = 0.73 95% CI = 0.58–0.92


A trend towards improved OS was observed with afatinib compared with gefitinib, although this was not statistically significant (HR=0.85 [95% CI: 0.66–1.09], p=0.1950). Consistent OS outcomes were observed across all age groups and EGFR mutation subgroups.

Hazard ratio = 0.85 95% CI = 0.66–1.09
LUX-Lung 7: figure for progression-free survival (PFS) with afatinib vs gefitinib

CI, confidence interval.

ORR and duration of response:

ORR (by independent central review) in the overall population was significantly improved with afatinib vs gefitinib with the median duration of response being 10.1 months (95% CI: 7.8–11.1) with afatinib vs 8.4 months (95% CI: 7.4–10.9) with gefitinib.

LUX-Lung 7: figure for objective response rate (ORR) with afatinib vs gefitinib


Adverse events (AEs) in both groups were consistent with previous experience, and were manageable leading to equally low rates of treatment discontinuation (rate of drug-related AEs leading to discontinuation was 6.3% for both treatment groups).


LUX-Lung 7 confirms the benefit of irreversible ErbB blockade with afatinib over reversible EGFR inhibition with gefitinib in the treatment of EGFR mutation-positive NSCLC.

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Park K, et al. Lancet Oncol 2016; 17(5):577–589.


Paz-Ares L, et al. Ann Oncol 2016; 27 (Suppl 6): Abstract LBA43.

3 (Accessed: September 2020).


Corral J, et al. Poster presented at ELCC 2017; Abstract 93PD.

*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 click here. Registration conditions differ internationally; please refer to locally approved prescribing information.


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Page last updated: December 2020