LUX-Lung 7 – 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 randomised, 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 CTgov-Identifier: 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 Eastern Cooperative Oncology Group performance status of 0–1
N = 319

Randomisation 1:1

  • Afatinib 40 mg
    Oral once daily

  • Gefitinib 250 mg
    Oral once daily


Primary Outcome Measures:
Progression‑free survival (PFS), assessed by independent 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 rate
Tumour 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.


Afatinib treatment was associated with a significant (p=0.0073) improvement in TTF (time from randomisation 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.


A trend towards improved OS was observed with afatinib compared with gefitinib, although this was not statistically significant (HR=0.86 [95% CI: 0.66–1.12], p=0.2580). Consistent OS outcomes were observed across all age groups and EGFR mutation subgroups.

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.


Adverse events (AEs) in both groups were consistent with previous experience (drug-related AEs afatinib=98.8%, gefitinib=100.0%), 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.


Park K, Tan EH, O’Byrne K, et al. Afatinib versus gefitinib as first-line treatment of patients with EGFR mutation-positive non-small cell lung cancer (LUX‑Lung 7): a phase 2B, open-label, randomised controlled trial. Lancet Oncol 2016; 17(5):577–589.

Paz-Ares L, Tan EH, Zhang L, et al. Afatinib (A) vs gefitinib (G) in patients (pts) with EGFR mutation-positive (EGFRm+) non-small cell lung cancer (NSCLC): overall survival (OS) data from the phase IIb trial LUX-Lung 7 (LL7). Ann Oncol 2016; 27 (Suppl 6): Abstract LBA43. (Accessed: April 2017).