DETERMINE Trial: Evaluating Alectinib in Adult, Paediatric, and Teenage/Young Adult Patients With ALK-Positive Rare and Common Cancers

What this Trial Is About

Researchers are evaluating the drug alectinib, which is currently approved for certain types of lung cancer with an ALK mutation, in patients with other rare or less common cancers that also have this mutation. The study includes adult, paediatric, and teenage/young adult patients with ALK-positive cancers. This trial is part of the DETERMINE programme, which aims to match targeted therapies to rare cancers or those with specific genetic changes, with the goal of expanding treatment options through the NHS if results are positive. Participants will receive alectinib orally, with adults and eligible paediatric patients weighing at least 40 kg taking 600 mg twice daily in 28-day cycles. Treatment continues until the cancer progresses, serious side effects occur, or the patient chooses to stop. Before treatment, patients undergo biopsy and blood sample collection. During treatment, blood samples are collected at intervals and at the end of treatment. After completing treatment, patients are followed up every three months for two years. Throughout the study, patients will have regular disease assessments up to 24 weeks and beyond to measure tumor response and clinical benefit. Additional evaluations include quality of life surveys, safety monitoring for adverse reactions, and long-term follow-up for up to five years. Researchers will track outcomes such as duration of response, progression-free survival, overall survival, and adverse events. This comprehensive monitoring helps assess alectinib's impact on various ALK-positive cancers.

DETERMINE Trial Treatment Arm 01: Alectinib in Adult, Paediatric and Teenage/Young Adult Patients With ALK Positive Cancers