Safety and Efficacy of BKM120 in Patients With Metastatic Non-small Cell Lung Cancer

Inclusion Criteria:

• Histologically confirmed NSCLC with activated PI3K pathway
• Progressive disease after prior systemic antineoplastic treatment(s) for advanced NSCLC
• Archival or fresh tumor biopsy must be available for profiling
• Measurable and/or non-measurable disease as per RECIST 1.1 criteria
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
• Adequate organ function as assessed by laboratory tests

Exclusion Criteria:

• Patient has received previous treatment with PI3K inhibitors
• Patient with squamous NSCLC has received more than one line of chemotherapy treatment for metastatic disease; patient with non-squamous NSCLC has received more than two lines of systemic antineoplastic treatment for metastatic disease
• Uncontrolled or symptomatic CNS metastases
• Concurrent use of any other approved or investigational antineoplastic agent
• Radiotherapy ≤ 28 days prior to starting study drug
• Major surgery within 28 days prior to starting study drug
• History of clinically significant cardiac dysfunction, mood disorders, or poorly controlled diabetes mellitus
• Current treatment with medication that has a known risk to prolong the QT interval or inducing Torsades de Pointes
• Impairment of gastrointestinal (GI) function
• Chronic treatment with steroids or another immunosuppressive agent.
• Concurrent severe and/or uncontrolled medical condition
• Currently receiving Warfarin or another coumarin derivative
• Known history of HIV infection
• Sensory neuropathy with functional impairment (CTC grade 2 neuropathy, regardless of causality)
• Pregnancy, lactation, or breastfeeding
• Woman of child-bearing potential

Other protocol-defined inclusion/exclusion criteria may apply