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 (CUBIK)

Fundacion GECP0 sites33 target enrollmentFebruary 27, 2024

ConditionsALK+ non-small cell lung cancer MedDRA version: 20.0Level: LLTClassification code: 10025055Term: Lung cancer non-small cell stage IV Class: 10029104 Therapeutic area: Diseases [C] - Neoplasms [C04]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: ALK+ non-small cell lung cancer
Sponsor: Fundacion GECP
Enrollment: 33
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 27, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Fundacion GECP

Eligibility Criteria

Inclusion Criteria

•Male or female, aged equal or greater \=18 years old, 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, Adequate hematologic and organ function, All patients are notified of the investigational nature of this study and signed a written informed consent in accordance with institutional and national guidelines, including the Declaration of Helsinki prior to any trial\-related intervention., Willingness and ability to comply with scheduled visits and study procedures, For female patients of childbearing potential, a negative pregnancy test must have been documented prior to enrollment (within 14 days prior to enrollment), ECOG performance status of 0\-2, Histologically or cytologically confirmed, Stage IIIB or IV NSCLC, Patients who have documented locally ALK rearrangement, No prior treatment for Stage IIIB or IV non\-squamous NSCLC., Having a life expectancy \= 3 months, 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., Untreated or treated CNS metastases allowed, as long as asymptomatic and neurologically stable, Patients with at least 1 measurable lesion, as defined by RECIST v1\.1

Exclusion Criteria

•Patients with a known sensitizing mutation in the epidermal growth factor receptor (EGFR) gene, STK\-1 Ligand alteration, MDM2 amplification or ROS1 translocations., Have uncontrolled hypertension, Positive test for HIV. A and patients with active hepatitis B or active tuberculosis, Severe infections within 2 weeks prior to be included in the study, Have significant, uncontrolled or active cardiovascular disease, Patients with illnesses or conditions that interfere with their capacity to understand follow and/or comply with study procedures, Patients that received any prior TKI, including ALK\-targeted TKIs or any systemic anticancer therapy for locally advanced or metastasic disease, Patients that have received chemotherapy or radiation within 14 days of first dose of study drug., 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, Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with leptomeningeal disease and without cord compression is allowed., Malignancies other than NSCLC within 3 years prior to enrollment, Women who are pregnant, lactating, or intending to become pregnant during the study, Patients that received monoclonal antibodies or had major surgery within 30 days of the first dose of brigatinib, 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.