Study Design   |   PFS   |   OS   |   HRQoL   |   Safety

 

LUX-Lung 8 Clinical Trial

Afatinib compared with erlotinib for the treatment of 2nd-line SqCC after prior platinum-based chemotherapy.

Read the original LUX-Lung 8 publication.


Study design

An open-label, phase III, randomised and controlled trial which compared afatinib with erlotinib in patients with stage IIIB or IV squamous cell carcinoma of the lung, who had progressed after at least 4 rounds of platinum-based chemotherapy (n=795). Participants were randomly assigned (1:1) to receive afatinib (40 mg per day) or erlotinib (150 mg per day) until disease progression. The primary endpoint was PFS by independent review and the key secondary endpoint was OS.1


PFS

Afatinib significantly improved PFS compared with erlotinib in unselected NSCLC patients who received prior chemotherapy1

LUX-Lung 8: PFS in unselected 2nd-line SqCC patients after chemotherapy*1

Adapted from Soria JC, et al. 2015.1


OS

Afatinib showed superior OS compared with erlotinib in patients with unselected 2nd-line SqCC after chemotherapy1

LUX-Lung 8: OS in unselected 2nd-line SqCC patients after chemotherapy1

Adapted from Soria JC, et al. 2015.1


HRQoL

Afatinib improved cough and quality of life compared with erlotinib in 2nd-line SqCC following chemotherapy1

LUX-Lung 8: improvements in symptoms in unselected 2nd-line SqCC patients after chemotherapy1

Adapted from Soria JC, et al. 2015.1


Safety

The most common AEs for afatinib were diarrhoea, rash, acne, stomatitis and fatigue.1


*Displayed are the results of the PFS assessment performed at the time of OS assessment. Primary analysis of PFS was performed once the requisite number of events judged by central independent review had been reached and occurred while recruitment was ongoing. Median PFS for afatinib and erlotinib was 2.6 and 1.9 months, respectively (HR: 0.81; 95% CI: 0.69–0.96; p=0.0103).1

AE=adverse events, EGFR M+=epidermal growth factor receptor mutation positive, HRQoL=health-related quality of life, ORR=objective response rate, OS=overall survival, PFS=progression-free survival, SqCC=squamous cell carcinoma, TTF=time-to-treatment failure


References

1
Soria JC, et al. Lancet Oncol 2015;16(8):897–907.