NSCLC afatinib clinical trials / studies

NSCLC afatinib clinical trials / studies

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

Afatinib’s Clinical Trials In NSCLC

The approval of afatinib for the treatment of TKI-naïve patients with locally advanced or metastatic, EGFR mutation-positive NSCLC is based on the global Phase III LUX-Lung 3 study1 and its Phase III sister trial in Asia, LUX-Lung 6.2

Afatinib is also indicated for the treatment of patients with locally advanced or metastatic squamous NSCLC that has progressed on or after platinum-based chemotherapy, based on the Phase III LUX-Lung 8 study.3 

The approval of afatinib for the treatment of TKI-pretreated patients is based on the Phase IIB/III LUX-Lung 1 study.4

The following table shows the clinical trials of afatinib in lung cancer; you can find links to further information on this site and published papers.

LUX-Lung 2

Phase II
LUX-Lung 2
Patients whose tumours harbour EGFR mutations (first-line)

LUX-Lung 4

Phase I/II
LUX-Lung 4
Patients who have been pretreated with erlotinib/ gefitinib (second/third-line)

Ongoing clinical trials

Afatinib plus cetuximab6-8

The combination of afatinib and cetuximab has been investigated in two Phase Ib clinical studies.6-8 These showed the maximum tolerated dose for the combination to be afatinib 40 mg/day plus cetuximab at either 500 mg/m2 Q2W or 250 mg/m2/week.In one of these studies, in 126 patients with stage IIIB/IV EGFR mutation-positive NSCLC who had progressed on erlotinib or gefitinib, ORR was 29% and median PFS was 4.7 months, with no reported difference in ORR or PFS according to T790M status.6,7

In the second study, in 49 patients with squamous NSCLC (n=12), head and neck squamous cell carcinoma (HNSCC; n=15) or other solid tumours (n=22), treatment with afatinib* plus cetuximab resulted in a disease control rate of 75% in patients with squamous NSCLC and 55% in the overall population.6,8

The safety profile of afatinib plus cetuximab was predictable and manageable in both studies. Tolerability-guided dose adjustment of afatinib reduced the frequency and intensity of treatment-related AEs.6



Sequist LV, et al. J Clin Oncol 2013;31(27):3327–34.


Wu YL, et al. Lancet Oncol 2014;15(2):213–22.


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


Miller VA, et al. Lancet Oncol 2012;13(5):528–38.


Clinicaltrials.gov. https://clinicaltrials.gov/ct2/show/record/NCT02597946 (Accessed: August 2017).


Soria J-C, et al. Poster presented at CSCO 2017 (Poster P24).


Clinicaltrials.gov. https://www.clinicaltrials.gov/ct2/show/record/NCT01090011 (Accessed: October 2017).


Clinicaltrials.gov. https://www.clinicaltrials.gov/ct2/show/record/NCT02020577 (Accessed: October 2017).

*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.