Actively Recruiting
DETERMINE Trial Treatment Arm 01: Alectinib in Adult, Paediatric and Teenage/Young Adult Patients With ALK Positive Cancers
Led by Cancer Research UK · Updated on 2025-11-24
30
Participants Needed
27
Research Sites
302 weeks
Total Duration
On this page
Sponsors
C
Cancer Research UK
Lead Sponsor
U
University of Manchester
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
DETERMINE Trial Treatment Arm 01: Alectinib in Adult, Paediatric and Teenage/Young Adult Patients With ALK Positive Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of an ALK-positive cancer using validated next-generation sequencing.
- Women of childbearing potential must have a negative pregnancy test before enrollment and agree to use highly effective birth control during and for three months after treatment.
- Male patients with partners of childbearing potential must agree to use barrier contraception or abstinence during and for three months after treatment.
- Patients must be able and willing to undergo fresh tissue biopsy or provide blood, bone marrow, or lymph node samples as appropriate.
- Pediatric patients under 18 years must weigh at least 40 kg.
- Adult patients (18 years and older) must have adequate organ function based on blood tests.
- Pediatric patients must have adequate organ function based on defined blood test ranges.
You will not qualify if you...
- Diagnosis of ALK-positive non-small cell lung cancer.
- Female patients who are pregnant, breastfeeding, or planning pregnancy during the trial or for three months afterward.
- Prior treatment with the same drug class unless resistance is known to be potentially sensitive to alectinib.
- History or evidence of interstitial lung disease or pneumonitis, except resolved localized radiotherapy pneumonitis.
- Risk factors for gastrointestinal perforation unless protected by gastric treatment.
- Inability to swallow or tolerate oral medication or certain gastrointestinal disorders.
- Significant pre-existing cardiac conditions like uncontrolled angina, arrhythmias, or severe heart failure.
- Recent cerebrovascular or cardiovascular events within three months before treatment.
- History of organ transplantation.
- Symptomatic slow heart rate for age.
- Known allergy to alectinib or its ingredients.
- Recent live attenuated vaccine use or need during treatment or six months afterward.
- Active hepatitis B or C, or uncontrolled HIV/AIDS.
- History of congenital bone disorders or osteopenia.
- Any other significant disease or condition that could interfere with treatment or pose unacceptable risk.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 27 locations
1
Belfast City Hospital
Belfast, United Kingdom, BT9 7AB
Actively Recruiting
2
University Hospital Birmingham
Birmingham, United Kingdom, B15 2TT
Actively Recruiting
3
Birmingham Children's Hospital
Birmingham, United Kingdom
Not Yet Recruiting
4
Bristol Royal Hospital for Children
Bristol, United Kingdom, BS2 8BJ
Actively Recruiting
5
Bristol Haematology and Oncology Centre
Bristol, United Kingdom, BS2 8ED
Actively Recruiting
6
Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 OQQ
Actively Recruiting
7
Velindre Cancer Centre
Cardiff, United Kingdom, CF14 2TL
Actively Recruiting
8
Cardiff Children's Hospital
Cardiff, United Kingdom, CF14 4XW
Not Yet Recruiting
9
Western General Hospital
Edinburgh, United Kingdom, EH4 2XU
Actively Recruiting
10
The Beatson Hospital
Glasgow, United Kingdom, G12 OYN
Actively Recruiting
11
Royal Hospital for Children Glasgow
Glasgow, United Kingdom, G51 4TF
Actively Recruiting
12
Leicester Royal Infirmary
Leicester, United Kingdom, LE1 5WW
Actively Recruiting
13
Alder Hey Hospital
Liverpool, United Kingdom, L14 5AB
Actively Recruiting
14
University College London Hospital
London, United Kingdom, NW1 2BU
Actively Recruiting
15
Guy's Hospital
London, United Kingdom, SE1 9RT
Actively Recruiting
16
Great Ormond Street Hospital
London, United Kingdom, WC1N 3JH
Actively Recruiting
17
Royal Manchester Children's Hospital
Manchester, United Kingdom, M13 9WL
Not Yet Recruiting
18
The Christie Hospital
Manchester, United Kingdom, M20 4BX
Actively Recruiting
19
Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, United Kingdom, CH63 4JY
Actively Recruiting
20
Great North Children's Hospital
Newcastle, United Kingdom, NE1 4LP
Actively Recruiting
21
Freeman Hospital
Newcastle, United Kingdom, NE7 7DN
Actively Recruiting
22
Churchill Hospital
Oxford, United Kingdom, OX3 7LE
Actively Recruiting
23
John Radcliffe Hospital
Oxford, United Kingdom, OX3 9DU
Actively Recruiting
24
Weston Park Hospital
Sheffield, United Kingdom, S10 2SJ
Actively Recruiting
25
Sheffield's Children's Hospital
Sheffield, United Kingdom, S10 2TH
Actively Recruiting
26
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
27
The Royal Marsden Hospital
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
A
Aida Sarmiento Castro
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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