LUX Lung 1 clinical trial infographic

Boehringer Ingelheim

LUX-Lung 1 is a clinical Phase IIb/III randomised, double-blind study evaluating afatinib* in combination with best supportive care (BSC) versus placebo plus BSC in patients with advanced non-small-cell lung cancer (NSCLC). Patients’ disease has progressed after prior chemotherapy and epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) gefitinib or erlotinib treatment. Due to the study inclusion criteria a high proportion of patients that may have mutated EGF receptors in their tumours were included. 585 male and female patients took part in the LUX-Lung 1 trial.

The primary endpoint was overall survival (OS). The secondary endpoints were progression-free survival (PFS), tumour shrinkage as determined by Response Evaluation Criteria in Solid Tumors (RECIST response), disease related symptom control (quality of life; QoL) and safety.

*Afatinib (compound code BIBW 2992) is an investigational compound. Its safety and efficacy has not yet been fully established.

1.    Miller et al. Phase IIb/III double-blind randomized trial of BIBW 2992, an irreversible inhibitor of EGFR/HER1 and HER2 + best supportive care (BSC) versus placebo + BSC in patients with NSCLC failing 1–2 lines of chemotherapy and erlotinib or gefitinib (LUX-Lung 1). Oral presentation at the 35th European Society of Medical Oncology (ESMO) annual meeting, Milan, October 2010. Abstract ID: LBA1.

2.    Miller et al. Subgroup analysis of LUX-Lung 1: A randomized Phase III Trial of Afatinib (BIBW 2992) + Best Supportive Care (BSC) versus Placebo + BSC in Patients with NSCLC Failing 1-2 Lines of Chemotherapy and Erlotinib or Gefitinib. Oral presentation at Chicago Multidisciplinary Symposium in Thoracic Oncology, Chicago, USA, 10 December, 2010.

3.    Jackman D et al. Clinical definition of acquired resistance to epidermal growth factor receptor tyrosine kinase inhibitors in non-small-cell lung cancer. J Clin Oncol 2010; 28 (2): 357-60.