Spots Global Cancer Trial Database for Brigatinib Post Definitive Chemo-radiotherapy in Patients With ALK-fusion Non-small Cell Lung Cancer
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Trial Identification
Brief Title: Brigatinib Post Definitive Chemo-radiotherapy in Patients With ALK-fusion Non-small Cell Lung Cancer
Official Title: A Multicentre, Randomised, Phase II Trial of Brigatinib Consolidation Versus Observation or Durvalumab in Patients With Unresectable Stage III NSCLC and ALK-rearrangement, After Definitive Chemo-radiotherapy
Study ID: NCT05718297
Study Description
Brief Summary: BOUNCE is an international multicentre randomised phase II trial. The trial treatment consists of brigatinib 180 mg once daily p.o., with seven day lead-in at 90 mg once daily, for 3 years or until progression of disease. The primary objective of this trial is to evaluate the efficacy in terms of progression-free survival (PFS) for brigatinib consolidation, compared to observation/durvalumab, in patients with unresectable stage III NSCLC and ALK-rearrangement who completed definitive chemo-radiotherapy without disease progression.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
CHU Angers, Angers, , France
Caen - CHU, Caen, , France
Hôpital de Marseille, Marseille, , France
IRCCS Instituto Tumori Giovanni Paolo II, Bari, , Italy
IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST), Meldola, , Italy
AOU Maggiore della Carità, Novara, , Italy
Fondazione IRCCS Policlinico S. Matteo, Pavia, , Italy
Santa Maria della Misericordia Hospital, Perugia, , Italy
AULSS2 Marca Trevigiana Treviso, Treviso, , Italy
Universita di Verona - Department of Medicine, Verona, , Italy
Medical University Gdansk, Gdańsk, , Poland
Hospital Universitario Dr Balmis Alicante - ISABIAL, Alicante, , Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Hospital Vall d'Hebron, Barcelona, , Spain
Hospital Universitario Basurto, Bilbao, , Spain
Hospital Universitario de Jerez de la Frontera, Jerez De La Frontera, , Spain
Hospital Universitario Lucus Augusti, Lugo, , Spain
H. Puerta de Hierro Majadahonda, Majadahonda, , Spain
Royal Marsden Hospital (Fulham Road), London, , United Kingdom
Royal Marsden Hospital (Sutton), London, , United Kingdom
Contact Details
Name: Rafal Dziadziuszko, MD
Affiliation: Dept. of Oncology and Radiotherapy, Medical University of Gdansk
Role: STUDY_CHAIR
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