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