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NSCLC afatinib clinical trials

Afatinib* has been extensively investigated as part of the LUX-Lung clinical trial programme. Within this section you will find an overview of the main trials in this programme as well as links to pages for further information.

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 4

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

LUX-Lung 2

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

Ongoing clinical trials


A Phase II Study of Afatinib in Patients With Advanced NSCLC Harbouring HER2 Mutations, Previously Treated With Chemotherapy

Phase II trial of afatinib in patients with NSCLC harbouring HER2 mutations

ECOG PS, Eastern Cooperative Oncology Group performance status; HER 2, human epidermal growth factor receptor 2; NSCLC, non-small call lung cancer; ORR, objective response rate; RECIST, Response Evaluation Criteria In Solid Tumors.

LUX-Lung IO6,7

A Phase II, Open Label, Non-randomised Study of Afatinib in Combination With Pembrolizumab in Patients With Locally Advanced or Metastatic Squamous Cell Carcinoma of the Lung

Phase II trial of afatinib plus pembrolizumab in advanced SqCC

NSCLC, non-small call lung cancer; OR, objective response.

Afatinib plus cetuximab8–10

The combination of afatinib and cetuximab has been investigated in two Phase Ib clinical studies.x 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.x

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.x

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.x

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.x



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.

5 (Accessed: August 2017).

6 (Accessed: August 2017).

*Afatinib is approved in more than 70 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.