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