Non-small-cell lung cancer (NSCLC) is considered by many to be the poster child for personalized medicine in oncology. The approval of tyrosine kinase inhibitors (TKIs) for the treatment of EGFR-mutation-positive and ALK-translocation-positive NSCLC patients has redefined the NSCLC treatment algorithm and developers are now in fierce competition to be the first to market novel, more efficacious and better tolerated TKIs which can be used as follow-on treatment options or replacements for currently approved front-line TKIs.

While approximately 60% of TKI-naive patients respond to TKI treatment, all eventually develop resistance to the drug and progress. For most medical oncologists, the preferred treatment approach is to administer platinum-based doublet-chemotherapy (± Avastin [Genentech/Roche/Chugai's bevacizumab]), although performance status, comorbidities and age restrict use; many patients are thus treated with single-agent chemotherapy. Due to the variability of treatment choices and the absence of a standard of care, medical oncologists have been long calling for therapies to treat EGFR inhibitor and more recently ALK inhibitor refractory patients.

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