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LUX-Lung IO clinical trial

Afatinib in Combination with Pembrolizumab in Patients with Stage IIIB/IV Squamous Cell Carcinoma of the Lung

A Phase II, open-label, single-arm trial of afatinib* in combination with pembrolizumab in patients with locally advanced or metastatic squamous cell lung carcinoma (SqCC) who have progressed during or after first-line, platinum-based chemotherapy.

Trial NCT03157089


Trial design


QD, once daily; Q3W, every 3 weeks; RP2D, recommended Phase II dose


  • Pathologically confirmed diagnosis of Stage IIIB/IV non-small cell lung cancer of squamous/mixed histology
  • Progression on or after ≥2 cycles of first-line, platinum-based chemotherapy
  • Eastern Cooperative Oncology Group performance status of 0 or 1
  • No prior therapy with immune checkpoint inhibitors or epidermal growth factor receptor inhibitors


Primary outcome measure:

  • Objective response rate


Secondary outcome measures:

  • Disease control rate
  • Duration of objective response
  • Progression-free survival
  • Overall survival
  • Tumour shrinkage
  • Recommended Phase II dose

Trial Status

The safety run-in is ongoing in the USA, Spain, France, Turkey and South Korea.


1 (Accessed: March 2018).


Levy B, et al. Poster presented at ASCO 2018 (Poster TPS9117).

*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.


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Last updated: June 2018