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Protocol Summary


Protocol No.
PSCI-21-038
Prinicipal Investigator
Ma, Patrick
Phase
Phase I
Age Group
Adult
Scope
Local
Secondary Protocol No.
COH IRB # 20495
Title
Phase Ib Study of Brigatinib Plus Bevacizumab in Patients with ALK- rearranged Non-Small Cell Lung Cancer (NSCLC) Who Have Previously Progressed on Prior ALK-Directed Therapy
Objective
Primary Objectives:
To evaluate the toxicities and tolerability and to identify the maximum tolerated dose (MTD) of brigatinib combined with bevacizumab in patients with ALK rearranged NSCLC who have previously progressed on prior ALK-directed therapy.

Secondary Objectives:
1. To describe the dose-limiting toxicities of brigatinib in combination with bevacizumab and determine the recommended phase II dose (RP2D).
2. To estimate overall response rate (ORR) to treatment with brigatinib and bevacizumab. ORR will be measured according to RECIST v1.1.
3. To estimate the duration of response as defined by the time of first documented clinical benefit to the time of progression.
4. To estimate patient survival by measuring progression free survival (PFS) and overall survival (OS).

Exploratory Objectives:
1. To identify predictive biomarkers using genetics and tumor immunology-based assessment platforms:
i. Analysis with next-generation sequencing (NGS) to identify predictive biomarkers for response using tumor tissue and CSF (optional for patients with brain metastases). Tumor tissue will be collected at baseline (archival if available, optional new biopsy) and the time of progression/study completion. CSF will be collected in consenting patients at C1D1, C2D1, and the time of the progression.
ii. Tumor tissue will be obtained at baseline, and cell free DNA (cfDNA)/circulating tumor DNA (ctDNA) obtained at baseline and the time of progression/study completion will be evaluated for genomic alterations and biomarkers.
2. Evaluation of central nervous system (CNS) penetration through cerebral spinal fluid (CSF) obtained by lumbar puncture on C2D1 (with time matched PK blood draw), and at progression/study
completion for consenting patients (Optional).
Applicable Disease Sites
Lung
Status
Open
Participating Institutions
Hershey Medical Center