DETERMINE Trial Treatment Arm 03: Entrectinib in Adult, Paediatric and Teenage/Young Adult Patients With ROS1 Gene Fusion-Positive Cancers.

This clinical trial is looking at a drug called entrectinib. Entrectinib is approved as standard of care treatment for adult patients with non-small cell lung cancer (NSCLC) which have a particular molecular alteration called ROS1-positive, and patients 12 years old or above with solid tumours which have another type of change in the cancer cells. This means it has gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Investigators now wish to find out if it will be useful in treating patients with other cancer types which have the same molecular alteration (ROS1-positive). If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future. This trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.

NCT Number	NCT05770544
Lead Sponsor	Cancer Research UK Collaborators: University of Manchester, University of Birmingham, Royal Marsden NHS Foundation Trust, Hoffmann-La Roche
Conditions	Haematological Malignancy, Malignancy, Malignant Neoplasm, Lymphoproliferative Disorders, Neoplasms by Histologic Type, Neoplasms by Site, Cancer, Brain Neoplasms +3 more
Enrollment	30 participants
Start Date	2025-11-30
Primary Completion	2029-10 (estimated)
Study Completion	2029-10 (estimated)
Updated on ClinicalTrials.gov	2025-11-24