Afatinib clinical trials results in NSCLC

Afatinib has been extensively investigated as part of the LUX-Lung clinical trial programme.

The table below gives an overview of the pivotal trials for afatinib, LUX-Lung 3, 6 and 8, as well as LUX-Lung 7, a head-to-head trial comparing afatinib and gefitinib for 1st-line use in EGFR M+ NSCLC.1–4

Explore the data and find out how your NSCLC patients could benefit from afatinib.

Description Primary Endpoint Selected

Secondary Endpoint

Phase III EGFR M+; 1st-line

Afatinib compared with cisplatin/pemetrexed

LUX-LUNG 31

PFS

OS; ORR; TTD; HRQoL; Safety

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Phase III EGFR M+; 1st-line

Afatinib compared with cisplatin/gemcitabine

LUX-LUNG 62

PFS

OS; ORR; TTD; HRQoL; Safety

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Phase IIb EGFR M+; 1st-line

Afatinib compared with gefitinib

LUX-LUNG 73

PFS; TTF; OS

ORR; time to and duration of OR; duration of disease control; tumour shrinkage; HRQoL

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Phase III Chemotherapy pre-treated squamous cell lung carcinoma

Afatinib compared with erlotinib

LUX-LUNG 84

OSa; ORR; tumour shrinkage; safety; HRQoL

Phase III Chemotherapy pre-treated squamous cell lung carcinoma

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LUX-LUNG 31 PHASE III

Phase III EGFR M+; 1st-line

Afatinib compared with cisplatin/pemetrexed


Primary Endpoint: PFS

Selected Secondary Endpoint: OS; ORR; TTD; HRQoL; Safety

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LUX-LUNG 62 PHASE III

Phase III EGFR M+; 1st-line

Afatinib compared with cisplatin/gemcitabine


Primary Endpoint: PFS

Selected Secondary Endpoint: OS; ORR; TTD; HRQoL; Safety

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LUX-LUNG 73 PHASE IIb

Phase IIb EGFR M+; 1st-line

Afatinib compared with gefitinib


Primary Endpoint: PFS; TTF; OS

Selected Secondary Endpoint: ORR; time to and duration of OR; duration of disease control; tumour shrinkage; HRQoL

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LUX-LUNG 84 PHASE III

PFS


Primary Endpoint: OSa; ORR; tumour shrinkage; safety; HRQoL

Selected Secondary Endpoint: Phase III Chemotherapy pre-treated squamous cell lung carcinoma

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aKey secondary endpoint

 

EGFR M+=epidermal growth factor receptor mutation positive, HRQoL=health-related quality of life, NSCLC=non-small-cell lung cancer; ORR=objective response rate, OS=overall survival, PFS=progression-free survival, TTD=time to deterioration, TTF=time to treatment failure.


References

1
Sequist LV, et al. J Clin Oncol 2013;31(27):3327–3334.
2
Wu YL, et al. Lancet Oncol 2014;15(2):213–222.
3
Park K, et al. Lancet Oncol 2016;17(5):577–589.
4
Soria JC, et al. Lancet Oncol 2015;16(8):897–907.