Non-Small Cell Lung Cancer Clinical Trial
Official title:
A Multi-Center Open-Label Phase I/2 Study of BGB324(Bemcentinib) in Combination With Erlotinib in Patients With Stage IIIb or Stage IV Non-Small Cell Lung Cancer
A Phase I/2 multi-center open-label study of BGB324 (bemcentinib) in combination with erlotinib in participants with Stage IIIb or Stage IV non-small cell lung cancer. Bemcentinib is a potent selective small molecule inhibitor of Axl, a surface membrane protein kinase receptor which is connected with poor prognosis and acquired resistance to therapy.
This is a multi-center, multi-arm open-label Phase I/2 study that will be conducted at up to 10 clinical sites in the US. Up to approximately 40 participants with histologically- or cytologically-confirmed Stage IIIb or Stage IV non-small cell lung cancer will receive bemcentinib( BGB324) as a single agent (Run-in Cohort(mono therapy)) or in combination with erlotinib (Arms A, B, C). Run-in Arm to establish the safety and tolerability of bemcentinib(BGB324) administered as a single agent bemcentinib will be administered at a loading dose of 600 mg on Day 1 and Day 2 of Cycle 1, followed by 200 mg daily thereafter. After 6 participants have been dosed and safety established Arm A ( dose escalation arm) will be opened to confirm the bemcentinib dose to be used in combination with erlotinib. In Arm A the dose of bemcentinib (BGB324) will be escalated in a standard 3+3 fashion until an maximum tolerated dose (MTD) of the combination (bemcentinib + erlotinib) is established. The dose of bemcentinib to be investigated in arm B and C will be confirmed upon recommendation of a Safety Review Committee. Arm B and C will open in parallel and will investigate bemcentinib in combination with erlotinib. ;
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