Brigatinib Post Definitive Chemo-radiotherapy in Patients with ALK-fusion Non-small Cell Lung Cancer

Inclusion Criteria

• •Pathologically documented, treatment naïve unresectable stage III NSCLC
• •Documented ALK-fusion, tested locally on tumour tissue by a validated method (DNA NGS, RNA NGS, FISH, IHC, or ctDNA)
• •ECOG Performance Status 0-1
• •Age ≥18 years
• •Patient is a candidate to receive chemo-radiotherapy, as per investigator's assessment (including adequate haematological, renal and liver function as per local guidelines).
• •Women of childbearing potential, including women who had their last menstruation in the last 2 years, must have a negative urinary or serum pregnancy test within 5 weeks before enrolment.
• •Ability to comply with the trial protocol, in the investigator's judgment.
• •Written IC for trial participation must be signed and dated by the patient and the investigator prior to any trial-related intervention, including the submission of mandatory biomaterial.
• •Eligibility criteria for randomisation Randomisation of eligible patients must occur within 8 weeks after the last radiotherapy fraction.
• •Completion of thoracic radiotherapy
• •Non-PD at restaging
• •Adequate haematological function
• •Adequate renal function
• •Adequate liver and pancreatic function
• •Women of childbearing potential, including women who had their last menstruation in the last 2 years, must have a negative urinary or serum pregnancy test before randomisation and should be repeated within 3 days before the first dose of brigatinib.
• •No radiation-pneumonitis of grade ≥2
• •All other AEs from previous chemo-radiotherapy resolved to grade \<2 (except for alopecia)
• •ECOG 0-2
• •No major surgery as defined by the investigator within 4 weeks of the the first planned dose of brigatinib.
• •Minor surgical procedures such as catheter placement or minimally invasive biopsies are allowed.
• •No systemic treatment with strong cytochrome p-450 (cyp)3a inhibitors, strong cyp3a inducers, or moderate cyp3a inducers within 14 days before randomisation.