Spots Global Cancer Trial Database for INC280 and Erlotinib Hydrochloride in Treating Patients With Non-small Cell Lung Cancer

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Trial Identification

Brief Title: INC280 and Erlotinib Hydrochloride in Treating Patients With Non-small Cell Lung Cancer

Official Title: Phase I Study of INC280 Plus Erlotinib in Patients With C-Met Expressing Non-Small Cell Lung Cancer

Study ID: NCT01911507

Conditions

Recurrent Non-small Cell Lung Cancer

Interventions

INC280

erlotinib hydrochloride

Study Description

Brief Summary: This phase I trial studies the side effects and best dose of c-Met inhibitor INCB028060 and erlotinib hydrochloride when given together in treating patients with previously treated non-small cell lung cancer. C-Met inhibitor INCB028060 and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed Description: PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose of INC280 (c-Met inhibitor INCB028060) plus erlotinib (erlotinib hydrochloride) in patients with met proto-oncogene (MET) expressing non-small cell lung cancer (NSCLC). SECONDARY OBJECTIVES: I. To describe the toxicity profile of INC280 plus erlotinib. II. To determine the preliminary efficacy of INC280 plus erlotinib. III. To characterize the pharmacokinetic behavior of this combination. TERTIARY OBJECTIVES: I. To collect blood and tumor samples for exploratory analysis of the MET and epidermal growth factor receptor (EGFR) signaling pathways. OUTLINE: This is a dose-escalation study. Patients receive c-Met inhibitor INCB028060 orally (PO) twice daily (BID) and erlotinib hydrochloride PO once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days.