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Spots Global Cancer Trial Database for Clinical Utility of Liquid Biopsy in Brigatinib ALK+ Patients

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We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Clinical Utility of Liquid Biopsy in Brigatinib ALK+ Patients

Official Title: 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

Study ID: NCT04223596

Interventions

Brigatinib

Study Description

Brief Summary: This is an open-label, non-randomised, phase II, exploratory, multi-country and multi-centre clinical trial. Chemotherapy-naïve patients with EML4-ALK rearrangement and with locally advanced or metastatic non-small cell lung cancer patients will be selected. Patients enrolled in the study will receive brigatinib 90mg for the first 7 days (D 1-7 at cycle 1) and then 180mg daily thereafter for QW4 cycles of duration (28 days ±3days). Brigatinib will be administered until progression disease, unacceptable toxicity, patient or physician decision to discontinue or death. Brigatinib may continue beyond disease progression per RECIST v1.1 until loss of clinical benefit, unacceptable toxicity, patient or physician decision to discontinue, or death as per SmPC recommendations. Patient accrual is expected to be completed within 1.5 years excluding a run-in-period of 4-6 months. Treatment and follow-up are expected to extend the study duration to a total of 5 years. Patients will be followed for 1 year after the end of treatment independently of the cause of end of treatment. The study will end once survival follow-up has concluded. The trial will end with the preparation of the final report, scheduled for 5.5 years after the inclusion of the first patient approximately.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Hospital Regional Universitario de Málaga, Málaga, Andalucia, Spain

ICO Badalona, Badalona, Barcelona, Spain

ICO Hospitalet, Hospitalet de Llobregat, Barcelona, Spain

Hospital de la Santa Creu i Sant Pau, Barcelona, Cataluña, Spain

Hospital Universitario Insular de Gran canaria, Las Palmas De Gran Canaria, Gran Canaria, Spain

Hospital Son Espases, Palma De Mallorca, Illes Balears, Spain

Hospital Universitario de Cruces, Baracaldo, Vizcaya, Spain

Complejo Hospitalario de A Coruña, A Coruña, , Spain

Hospital General de Alicante, Alicante, , Spain

Hospital Vall Hebron, Barcelona, , Spain

Hospital Universitario Fundación Jiménez Díaz, Madrid, , Spain

Hospital Puerta de Hierro, Madrid, , Spain

Hospital Clínico de Salamanca, Salamanca, , Spain

Hospital Universitari i Politécnic La Fe, Valencia, , Spain

Hospital General de Valencia, Valencia, , Spain

Contact Details

Name: Mariano Provencio, MD

Affiliation: Fundación GECP President

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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