OncoMatch/Clinical Trials/NCT05770037
DETERMINE Trial Treatment Arm 01: Alectinib in Adult, Paediatric and Teenage/Young Adult Patients With ALK Positive Cancers
Is NCT05770037 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies Alectinib for haematological malignancy.
Treatment: Alectinib — This clinical trial is looking at a drug called alectinib. Alectinib is approved as standard of care treatment for adult patients with certain types of lung cancer. This means it has gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Alectinib works in lung cancer patients with a particular mutation in their cancer known as ALK. Investigators now wish to find out if it will be useful in treating patients with other cancer types which have the same mutation. 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Multiple Myeloma
Myelodysplastic Syndrome
Chronic Lymphocytic Leukemia
Tumor Agnostic
Renal Cell Carcinoma
Neuroblastoma
Biomarker criteria
Required: ALK fusion
Prior therapy
Cannot have received: ALK inhibitor
Exception: unless genetic profile demonstrates a mechanism of resistance known to be potentially sensitive to alectinib. Patients who have previously received crizotinib (Xalkori®) and did not respond, or who responded inadequately or responded adequately and subsequently progressed, are allowed into the trial.
Prior treatment with the same class of drug unless genetic profile demonstrates a mechanism of resistance known to be potentially sensitive to alectinib. Patients who have previously received crizotinib (Xalkori®) and did not respond, or who responded inadequately or responded adequately and subsequently progressed, are allowed into the trial.
Lab requirements
Blood counts
Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol (adults); within the ranges shown below (paediatrics)
Kidney function
Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol (adults); within the ranges shown below (paediatrics)
Liver function
Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol (adults); within the ranges shown below (paediatrics)
ADULT PATIENTS (≥18 years): Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. PAEDIATRIC PATIENTS (<18 years): Adequate organ function as per haematological and biochemical indices within the ranges shown below.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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