Phase Ib Study of LDK378 and AUY922 in ALK-rearranged Non-small Cell Lung Cancer

Inclusion Criteria:

- locally advanced or metastatic NSCLC that has progressed during or following therapy
with an ALK inhibitor

- tumor must carry an ALK rearrangement in 15% or more of tumor cells as measured by
FISH

- disease that can be evaluated by RECIST v1.1 and measurable disease

Exclusion Criteria:

- central nervous system (CNS) metastases that are symptomatic or require increasing
steroids or CNS-directed therapy to control CNS disease

- history of interstitial lung disease or interstitial pneumonitis, including
clinically significant radiation pneumonitis

- clinically significant cardiac dysfunction

- inadequate end organ function as defined by specified laboratory values

- use of medications known to be strong inhibitors or inducters of CYP3A4/5 that cannot
be discontinued at least 1 week prior to start of treatment

- use of medications that are mainly metabolized by CYP3A4/5 or CYP2C9 that cannot be
discontinued at least 1 week prior to start of treatment

- clinically significant, uncontrolled impaired gastrointestinal function or GI disease

- prior treatment with a HSP90 inhibitor

- radiotherapy to lung within 4 weeks prior to the first dose of study treatment or
patients who have not recovered from radiotherapy-related toxicities

- pregnant or nursing women

- history of pancreatitis or history of increased amylase or lipase that was due to
pancreatic disease.