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Could a lung cancer drug treat rare tumors? new trial aims to find out

NCT ID NCT05770544

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This trial tests the drug entrectinib (Rozlytrek) in people with rare cancers that have a specific genetic change called ROS1 fusion. The drug is already approved for some lung cancers, but researchers want to see if it works for other tumor types. About 30 adults, teens, and children will take the drug daily until their cancer worsens or side effects become too severe. The main goals are to see if tumors shrink or stop growing for at least 24 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Entrectinib (Rozlytrek)
What this could lead to
If successful, this could expand the use of entrectinib to treat many rare cancers with a ROS1 gene fusion, offering a new option for patients with limited treatments.
What could go wrong
This is an early-phase trial with only 30 participants, so results may not apply to everyone. The drug may cause side effects or not work for all cancer types.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2025

An estimate. Start dates often move.

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

THE PATIENT MUST FULFIL THE ELIGIBILITY CRITERIA WITHIN THE DETERMINE MASTER PROTOCOL (NCT05722886) AND WITHIN THE TREATMENT ARM 03 (ENTRECTINIB) OUTLINED BELOW\* \*When entrectinib-specific inclusion/exclusion criteria or precautions below differ from those specified in the Master Protocol, the entrectinib-specific criteria will take precedence. Inclusion Criteria: A. Confirmed diagnosis of a ROS1 gene fusion-positive malignancy, other than NSCLC, that has been identified using an analytically validated next-generation sequencing method. B. Patients must be able and willing to undergo a fresh tissue biopsy at baseline and blood samples for translational research. Note that for patients with haematological malignancies or neuroblastomas, blood, bone marrow aspiration and/or trephine or lymph node biopsy samples may be taken. C. Patients with a BSA of 0.43m\^2 and over. D. ADULT PATIENTS (≥18 years): Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility. E. PAEDIATRIC PATIENTS (\<18 years): Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility. F. Women of childbearing potential are eligible provided that they meet the following criteria: * Have a negative serum or urine pregnancy test before enrolment and either: * Agree to use one form of highly effective birth control method such as: I. Oral, intravaginal or transdermal combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation II. Oral, injectable or implantable progestogen-only hormonal contraception associated with inhibition of ovulation III. Intrauterine device (IUD) IV. Intrauterine hormone-releasing system (IUS) V. Bilateral tubal occlusion VI. Vasectomised partner Plus a barrier method if using a hormonal method: male or female condom with or without spermicide; cap, diaphragm or sponge with spermicide OR • Sexual abstinence; Effective from the first administration of entrectinib, throughout the trial and for five weeks after the last administration of entrectinib. G. Male patients with partners who are women of childbearing potential are eligible provided that they agree to the following, from the first administration of entrectinib, throughout the trial and for three months after the last administration of entrectinib: * Agree to take measures not to father children by using a barrier method of contraception (condom plus spermicide) or to sexual abstinence. * Non-vasectomised male patients with partners who are women of childbearing potential must also be willing to ensure that their partner uses a highly effective method of contraception as in F above. * Male patients with pregnant or lactating partners must be advised to use barrier method contraception (e.g. condom) to prevent drug exposure of the foetus or neonate. All male patients must refrain from donating sperm for the same period. Exclusion Criteria: A. Female patients who are pregnant, breastfeeding or planning to become pregnant during the trial or within five weeks following their last dose of entrectinib B. Diagnosis of ROS1 fusion-positive NSCLC C. Prior treatment with the same class of drug unless genetic profile demonstrates a mechanism of resistance known to be potentially sensitive to entrectinib D. Patients with significant cardiovascular disease are excluded as defined by: i. Current congestive heart failure requiring therapy (New York Heart Association III or IV) or known left ventricular ejection fraction (LVEF) \<50% (moderate to severe). ii. History of unstable angina pectoris or myocardial infarction up to three months prior to trial entry, or current poorly controlled angina (symptoms weekly or more). iii. Presence of symptomatic or severe valvular heart disease (severe by local echo graphic criteria or American Heart Association/American Cardiac College Stage C or D). iv. History of a clinically significant cardiac arrhythmia up to three months prior to trial entry (asymptomatic atrial fibrillation or asymptomatic first-degree heart block are permitted. v. History of stroke (ischaemic or haemorrhagic) within the last three months. • Patients with primary CNS tumours may be considered unless intra-tumoural bleeding has occurred within 2 weeks of the first dose of entrectinib, and patients with punctate CNS haemorrhages \<3 mm may be considered. E. Patients with a baseline QTcF (Corrected QT interval by Fridericia formula) interval longer than 450 milliseconds (ms) for male patients and 470 ms for female patients, patients with congenital long QTcF syndrome, and patients taking medicinal products that are known to prolong the QTc interval. F. History of additional risk factors for Torsades de Pointes (e.g., family history of long QT syndrome) G. Grade ≥2 peripheral neuropathy H. Known active infections (bacterial, fungal or viral) that would interfere with the assessment of safety or efficacy of entrectinib, including human immunodeficiency virus (HIV) positivity. Patients with history of testing positive for HIV infection are eligible provided the each of the following conditions are met: * CD4 count ≥350/μL; * undetectable viral load; * receiving antiretroviral therapy (ART) that does not interact with IMP (patients should be on established ART for at least four weeks); and * no HIV/ acquired immune deficiency syndrome (AIDS)-associated opportunistic infection in the last 12 months. I. Known hypersensitivity to entrectinib or any of the excipients J. Patients who were administered a live, attenuated vaccine within 28 days prior to enrolment, or anticipation of need for such a vaccine during entrectinib treatment or within six months after the final dose of entrectinib K. Patient unable to swallow entrectinib intact, without chewing, crushing or opening the capsules (as per the dosing schedule and suitable dosing strengths available). Any active gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would reasonably affect drug absorption L. Patients with personal history of significant osteopenia (screening for osteopenia not required) M. Any clinically significant concomitant disease or condition (or its treatment) that could interfere with the conduct of the trial or absorption of oral medications that would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this trial

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    27 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Addenbrooke's Hospital

    RECRUITING

    Cambridge, CB2 OQQ, United Kingdom

  • Alder Hey Hospital

    RECRUITING

    Liverpool, L14 5AB, United Kingdom

  • Belfast City Hospital

    RECRUITING

    Belfast, BT9 7AB, United Kingdom

  • Birmingham Children's Hospital

    NOT_YET_RECRUITING

    Birmingham, United Kingdom

  • Bristol Haematology and Oncology Centre

    RECRUITING

    Bristol, BS2 8ED, United Kingdom

  • Bristol Royal Hospital for Children

    RECRUITING

    Bristol, BS2 8BJ, United Kingdom

  • Cardiff Children's Hospital

    NOT_YET_RECRUITING

    Cardiff, CF14 4XW, United Kingdom

  • Churchill Hospital

    RECRUITING

    Oxford, OX3 7LE, United Kingdom

  • Clatterbridge Cancer Centre

    RECRUITING

    Metropolitan Borough of Wirral, CH63 4JY, United Kingdom

  • Freeman Hospital

    RECRUITING

    Newcastle, NE7 7DN, United Kingdom

  • Great North Children's Hospital

    RECRUITING

    Newcastle, NE1 4LP, United Kingdom

  • Great Ormond Street Hospital

    RECRUITING

    London, WC1N 3JH, United Kingdom

  • Guy's Hospital

    RECRUITING

    London, SE1 9RT, United Kingdom

  • John Radcliffe Hospital

    RECRUITING

    Oxford, OX3 9DU, United Kingdom

  • Leicester Royal Infirmary

    RECRUITING

    Leicester, LE1 5WW, United Kingdom

  • Royal Hospital for Children Glasgow

    RECRUITING

    Glasgow, G51 4TF, United Kingdom

  • Royal Manchester Children's Hospital

    NOT_YET_RECRUITING

    Manchester, M13 9WL, United Kingdom

  • Sheffield's Children's Hospital

    RECRUITING

    Sheffield, S10 2TH, United Kingdom

  • Southampton General Hospital

    RECRUITING

    Southampton, SO16 6YD, United Kingdom

  • The Beatson Hospital

    RECRUITING

    Glasgow, G12 OYN, United Kingdom

  • The Christie Hospital

    RECRUITING

    Manchester, M20 4BX, United Kingdom

  • The Royal Marsden Hospital

    RECRUITING

    Sutton, SM2 5PT, United Kingdom

  • University College London Hospital

    RECRUITING

    London, NW1 2BU, United Kingdom

  • University Hospital Birmingham

    RECRUITING

    Birmingham, B15 2TT, United Kingdom

  • Velindre Cancer Centre

    RECRUITING

    Cardiff, CF14 2TL, United Kingdom

  • Western General Hospital

    RECRUITING

    Edinburgh, EH4 2XU, United Kingdom

  • Weston Park Hospital

    RECRUITING

    Sheffield, S10 2SJ, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.