Actively Recruiting
DETERMINE Trial Treatment Arm 03: Entrectinib in Adult, Paediatric and Teenage/Young Adult Patients With ROS1 Gene Fusion-Positive Cancers.
Led by Cancer Research UK · Updated on 2025-11-24
30
Participants Needed
27
Research Sites
200 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 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.
CONDITIONS
Official Title
DETERMINE Trial Treatment Arm 03: Entrectinib in Adult, Paediatric and Teenage/Young Adult Patients With ROS1 Gene Fusion-Positive Cancers.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have a confirmed diagnosis of ROS1 gene fusion-positive cancer other than non-small cell lung cancer, identified by validated genetic testing
- Be able and willing to undergo fresh tissue biopsy and provide blood samples for research
- Have a body surface area (BSA) of at least 0.43 m²
- Have adequate organ function based on blood tests (adults 18 years and older)
- Have adequate organ function based on blood tests (children under 18 years)
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception or sexual abstinence during treatment and for five weeks after
- Male patients with partners who can become pregnant must agree to use barrier contraception or abstinence during treatment and for three months after, and ensure partners use effective contraception
- Male patients must not donate sperm during treatment and for three months after
You will not qualify if you...
- Female patients who are pregnant, breastfeeding, or planning pregnancy during the trial or within five weeks after last dose
- Diagnosis of ROS1 fusion-positive non-small cell lung cancer
- Prior treatment with drugs in the same class unless specific resistance mechanism is present
- Significant cardiovascular disease such as heart failure, recent unstable angina, severe valve disease, recent stroke, or significant arrhythmias
- Baseline corrected QT interval longer than specified limits or taking medications that prolong QT interval
- History of conditions increasing risk of serious heart arrhythmia (Torsades de Pointes)
- Grade 2 or higher peripheral neuropathy
- Active infections that interfere with safety or efficacy assessment, including uncontrolled HIV infection
- Known allergy to entrectinib or its ingredients
- Recent or planned live attenuated vaccination during treatment or within six months after
- Inability to swallow entrectinib capsules intact or conditions affecting drug absorption
- History of significant bone loss (osteopenia)
- Any other significant medical condition or treatment that may interfere with trial participation or drug absorption as judged by the investigator
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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