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

NCT ID NCT05770037

Disease control Sponsor: Cancer Research UK Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a drug called alectinib, already approved for some lung cancers, in people with rare cancers that have a specific genetic change called ALK. About 30 adults, teens, and children with ALK-positive cancers will receive alectinib to see if it shrinks tumors or stops them from growing. The goal is to find new uses for existing drugs in hard-to-treat cancers.

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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.

Started

Dec 2023

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 01 (ALECTINIB) OUTLINED BELOW\* \*When alectinib-specific inclusion/exclusion criteria or precautions below differ from those specified in the Master Protocol, the alectinib-specific criteria will take precedence. Inclusion Criteria: A. Confirmed diagnosis of an ALK-positive malignancy using an analytically validated next-generation sequencing method. B. Women of childbearing potential are eligible, provided that they meet the following criteria: * Have a negative serum or urine pregnancy test before enrolment and; * Agree to use one form of highly effective birth control method such as: I. combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation \[oral, intravaginal or transdermal\] II. progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable) III. intrauterine device (IUD) IV. intrauterine hormone-releasing system (IUS) V. bilateral tubal occlusion VI. vasectomised partner VII. sexual abstinence Effective from the first administration of alectinib, throughout the trial and for three months after the last administration of alectinib. C. Male patients with partners who are women of childbearing potential are eligible provided that they agree to the following, from first administration of alectinib, throughout the trial and for three months after the last administration of alectinib: * Agree to take measures not to father children by using a barrier method of contraception (condom plus spermicide) or 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 criterion B, 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. D. Patients must be able and willing to undergo a fresh tissue biopsy. Note that for patients with haematological malignancies or neuroblastomas, blood, bone marrow aspiration and/or trephine or lymph node biopsy samples may be taken. E. Paediatric patients (patients aged \<18 years) must have a body weight ≥40kg. F. 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. G. PAEDIATRIC PATIENTS (\<18 years): Adequate organ function as per haematological and biochemical indices within the ranges shown below. These measurements should be performed to confirm the patient's eligibility. Exclusion Criteria: A. Diagnosis of ALK-positive non-small cell lung cancer. B. Female patients who are pregnant, breastfeeding or planning to become pregnant during the trial or for three months following their last dose of alectinib. C. 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. D. History of or radiological evidence of interstitial lung disease and/or pneumonitis. Prior localised radiotherapy related pneumonitis is permitted if resolved and off steroids and asymptomatic for \>6 months. E. Patients at risk of gastrointestinal (GI) perforation e.g. history of diverticulitis, concomitant use of medicinal product with a recognized risk of GI perforation (unless patient has also been co-prescribed gastric protection). • Patients who present with a GI primary tumour or metastases to the GI tract may be considered. F. Patient unable to swallow or tolerate oral medication or any GI disorder that may affect absorption of oral medications, such as malabsorption syndrome or following major bowel resection. Paediatric patients will be excluded if they are unable to swallow the capsules, as per the dosing schedule (150 mg dose strength). G. Patients with clinically significant pre-existing cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias (within three months), or New York Heart Association (NYHA) class III or IV congestive heart failure. Patients with a cerebrovascular event (including stroke or transient ischaemic attack \[TIA\]), or cardiovascular event (including acute myocardial infarction \[MI\]), within three months before the first dose of alectinib. • Patients with primary CNS tumours may be considered unless intra-tumoural bleeding has occurred within 2 weeks of the first dose of alectinib, and patients with punctate CNS haemorrhages \<3 mm may be considered. H. History of organ transplantation. I. Symptomatic bradycardia for age. J. Known hypersensitivity to alectinib or any of the excipients. See the current alectinib (Alecensa® 150 mg hard capsules) SmPC for the full list. K. Patients who were administered a live, attenuated vaccine within 28 days prior to enrolment, or anticipation of need for such a vaccine during alectinib treatment or within six months after the final dose of alectinib. L. Active hepatitis B or C virus or known human immunodeficiency virus (HIV) positivity or acquired immune deficiency syndrome (AIDS) related illness. 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/AIDS-associated opportunistic infection in the last 12 months. M. Familial or personal history of congenital bone disorders, bone metabolism alterations or known osteopenia in the patient. N. Any clinically significant concomitant disease or condition (or its treatment) that could interfere with the conduct of the trial or absorption of oral medications or 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.

anaplastic large cell lymphoma cancer hematopoietic and lymphoid cell neoplasm hematopoietic and lymphoid system neoplasm lymphoma lymphoproliferative syndrome neoplasm Neoplasms by Histologic Type Neoplasms by Site neuroblastoma renal cell carcinoma

As listed by the trial registrant

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

Anaplastic large cell lymphoma Cancer Haematological malignancy Lymphoma Lymphoproliferative disorders Malignant neoplasm Neoplasms by histologic type Neoplasms by site Neuroblastoma Renal cell carcinoma Solid tumour

How to take part

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

The places running it

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

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