Actively Recruiting

Phase 2
Phase 3
All Genders
NCT05770544

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

All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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