An open label two-stage study of orally administered BKM120 in patients with metastatic non-small cell lung cancer with activated PI3K pathway.

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

Patient has a histologically confirmed diagnosis of NSCLC with activated PI3K pathway as defined by PIK3CA mutation and/or PTEN mutation and/or PTEN Negative (<10% protein expression by IHC). ;For confirmation of the PI3K pathway activation status, the patient must sign a molecular prescreening ICF. The molecular prescreening ICF will allow tumortissue to be collected and shipped to a Novartis designated laboratory for analysis. A representative archival or fresh tumor biopsy must be available for shipping to a Novartis designated lab for molecular profiling. Prescreening is a study related assessment.;Patient has experienced objective progressive disease after the prior systemic antineoplastic treatment(s) for advanced NSCLC is/are required as follows:
group 1: diagnosis of squamous NSCLC that progressed after one prior systemic platinum based chemotherapy-line for metastatic disease
group 2: diagnosis of non-squamous NSCLC that progressed after one to two prior systemic antineoplastic therapy lines for metastatic disease.;ECOG performance status < 2

Exclusion Criteria

Patient has received previous treatment with PI3K inhibitors;Patient in stage 2 only:
a Squamous patients: previous treatment with docetaxel
b Nonsquamous patients: previous treatment with docetaxel and pemetrexed;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 ;Patient with uncontrolled or symptomatic CNS metastases;Patient has any of the following mood disorders as judged by the Investigator or a Psychiatrist, or meets the cut-off score of >12 in the PHQ-9 or a cut-off of >15 in the GAD-7 mood scale, respectively, or selects a positive response of 1, 2, 3to question number 9 regarding potential for suicidal thoughts ideation in the PHQ-0 (independent of the total score of the PHQ-9);Patient has active or history of cardiac disease

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Objective<br /><br>• To evaluate the efficacy of BKM120 based on disease Progression Free Survival<br /><br>(PFS)<br /><br>after initiating BKM treatment as measured by using RECIST criteria, in<br /><br>patients with<br /><br>activated PI3K pathway recurrent or metastatic NSCLC</p><br>

Secondary Outcome Measures

Name	Time	Method

Related Trials