This phase Ib trial finds the best dose and side effects of ensartinib and its effects when
given with carboplatin, pemetrexed and bevacizumab for in treating patients with ALK-positive
non-small cell lung cancer that is stage IIIC or IV, or has come back (recurrent). Ensartinib
may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Chemotherapy drugs, such as carboplatin and pemetrexed, work in different ways to stop the
growth of tumor cells, either by killing the cells, by stopping them from dividing, or by
stopping them from spreading. Bevacizumab is a monoclonal antibody that may interfere with
the ability of tumor cells to grow and spread. Giving ensartinib, carboplatin, pemetrexed and
bevacizumab may help to control the disease.
I. To determine the safety of ensartinib in combination with carboplatin, pemetrexed and
bevacizumab in patients with ALK-rearranged advanced non-small cell lung cancer (NSCLC).
II. Determine the recommended phase 2 dose (RP2D) of ensartinib in combination with
carboplatin, pemetrexed and bevacizumab.
I. To determine an objective response rate (ORR) in patients with ALK-rearranged advanced
NSCLC treated with ensartinib in combination with carboplatin, pemetrexed and bevacizumab
using modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
II. To determine progression-free survival (PFS). III. To determine overall survival.
I. To determine biomarkers associated with response and resistance to the study combination.
OUTLINE: This is a dose de-escalation study of ensartinib and fixed-dose carboplatin,
pemetrexed, and bevacizumab followed by a dose-expansion study.
INDUCTION THERAPY: Patients receive ensartinib orally (PO) once daily (QD) on days 1-21,
carboplatin intravenously (IV) over 15-60 minutes on day 1, pemetrexed IV over 10 minutes on
day 1 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up
to 4 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive ensartinib PO QD on days 1-21 and bevacizumab IV over
30-90 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or
After completion of study treatment, patients are followed up for 30 days.
Metastatic Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma, Stage IIIC Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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