Clinical Utility of Liquid Biopsy as a tool to assess the evolution of brigatinib treated patients with non-small cell lung cancer with EML4-ALK translocation: an exploratory study - Clinical Utility of liquid biopsy in Brigatinib ALK+ patients_CUBIK

Fundación GECP0 sites30 target enrollmentJanuary 14, 2020

Overview

No summary available.

Registry

who.int

Start Date

January 14, 2020

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Fundación GECP

•1\. Male or female, aged \= 18 years old
•2\. ECOG performance status of 0\-2
•3\. Histologically or cytologically confirmed, Stage IIIB or IV NSCLC
•4\. Patients who have documented locally ALK rearrangement
•5\. No prior treatment for Stage IIIB or IV non\-squamous NSCLC.
•6\. Having a life expectancy \= 3 months
•7\. Patients who have received prior neo\-adjuvant, adjuvant chemotherapy, radiotherapy, or chemo\-radiotherapy with curative intent for non\-metastatic disease must have experienced a treatment\-free interval of at least 6 months from enrollment since the last chemotherapy, radiotherapy, or chemo\-radiotherapy.
•8\. Untreated or treated CNS metastases allowed, as long as asymptomatic and neurologically stable
•9\. Patients with at least 1 measurable lesion, as defined by RECIST v1\.1
•10\. Normal QT interval (QT) on screening ECG evaluation, defined as QT interval corrected (Fridericia) (QTcF) of \= 450 milliseconds (msec) in males of \= 470 msec in females

•1\. Patients with a known sensitizing mutation in the epidermal growth factor receptor (EGFR) gene, STK\-1 Ligand alteration, MDM2 amplification or ROS1 translocations.
•2\. Patients that received any prior TKI, including ALK\-targeted TKIs or any systemic anticancer therapy for locally advanced or metastasic disease
•3\. Patients that have received chemotherapy or radiation within 14 days of first dose of study drug.
•4\. Symptomatic CNS metastases (parenchymal or leptomeningeal) that are neurologically unstable or required an increasing dose of corticosteroids within 7 days prior to first dose of study drug
•5\. Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with leptomeningeal disease and without cord compression is allowed.
•6\. Malignancies other than NSCLC within 3 years prior to enrollment
•7\. Women who are pregnant, lactating, or intending to become pregnant during the study.
•8\. Patients that received monoclonal antibodies or had major surgery within 30 days of the first dose of brigatinib
•9\. History of idiopathic pulmonary fibrosis, pulmonary interstitial disease, organizing pneumonia (e.g., bronchiolitis obliterans), drug\-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
•10\. Have uncontrolled hypertension