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.