Safety and Efficacy of Buparlisib (BKM120) in Patients With Untreated Squamous Non-small Cell Lung Cancer

Inclusion Criteria

• •Patient has histologically and/or cytologically confirmed diagnosis of squamous NSCLC. Diagnosis of mixed squamous with a squamous component will be acceptable for enrollment.
• •Patient has archival or new tumor tissue for the analysis of PI3K biomarkers
• •Tumor is Stage IV at the time of signed informed consent (UICC/AJCC version 7)
• •Patient has measurable or non-measurable disease according to RECIST v1.1 criteria
• •• For the Phase II portion, the patient must have measurable disease according to RECIST 1.1 criteria
• •Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 that the investigator believes is stable at the time of screening
• •Patient has adequate bone marrow and organ function
• •Patient has symptomatic CNS metastases
• •• Patients with asymptomatic CNS metastases may participate in this trial. The patient must have completed any prior local treatment for CNS metastases ≥ 28 days prior to the start of study treatment (including radiotherapy and/or surgery, or ≥14 days for stereotactic radiosurgery).
• •Patient is currently receiving warfarin or other coumadin derived anticoagulant for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed.
• •Patient is currently receiving treatment with drugs known to be strong inhibitors or inducers of isoenzyme CYP3A. The patient must have discontinued strong inducers for at least one week and must have discontinued strong inhibitors before the treatment is initiated. Switching to a different medication prior to randomization is allowed.