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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
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:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: Mariano Provencio, MD
Affiliation: Fundación GECP President
Role: PRINCIPAL_INVESTIGATOR