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Radioactive drug takes on standard therapy for rare lung and thymus cancers

NCT ID NCT05918302

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 trial tests whether a radioactive drug called 177Lu-edotreotide works better than the standard drug everolimus for people with advanced neuroendocrine tumors of the lung or thymus. About 170 participants will receive either six cycles of the radioactive therapy or daily everolimus pills. The main goal is to see which treatment delays tumor growth longer.

What this could mean

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

Active substance
177Lu-edotreotide (a radioactive drug) and everolimus (a targeted therapy)
What this could lead to
If successful, this could provide a more effective treatment option for people with advanced neuroendocrine tumors of the lung or thymus, potentially delaying tumor growth.
What could go wrong
This is a Phase 3 trial, but results are not yet known. The experimental therapy involves radiation and may have side effects. It may not prove superior to the existing drug everolimus.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 170 people

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

Started

Oct 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

18 years and older

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.

Inclusion Criteria: 1. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written informed consent. 2. Patients ≥ 18 years of age. 3. Patients who have histologically confirmed metastatic or locally advanced unresectable well/moderately differentiated; World Health Organization (WHO\]) 2015 criteria; neuroendocrine tumor of lung (typical and atypical carcinoids) or thymus origin either functioning or non-functioning. 4. Patients must have the appropriate pathological features based on WHO classification, and description of proliferation activity as indicated by mitotic count per 10 high-power fields (HPF) and presence of necrosis, or Ki67 index. 5. In SSTR imaging all RECIST v1.1 selected target lesions and all other lesions considered dominant by the investigator should be positive. If an fluorodeoxyglucose (FDG)-positron emission tomography (FDG-PET) is performed (not mandatory), all FDG-PET positive RECIST v1.1 target lesions and all other FDG-PET positive lesions considered dominant by the investigator should also be positive in SSRT imaging. 6. Lesions must have shown radiological evidence of disease progression in the 12 months prior to inclusion in the study. Patients who were receiving systemic anticancer therapy, progression should be documented on therapy or after stopping therapy due to adverse events or other reasons. Patients without prior therapy, documentation of progression is also mandatory to watch and wait strategy or during the follow up after surgery. 7. Patients may be included in first-line therapy (systemic treatment naïve) or may have experienced progression on somatostatin analogues or additional systemic treatments, which may include but not limited to chemotherapy, targeted agents or immunotherapy (maximum of 2 prior systemic anti-tumor treatments). Note: Somatostatin analogues for patients with functioning tumors are allowed. 8. Patients have radiographically documented and measurable metastatic or locally advanced disease at baseline according to RECIST v1.1. 9. An archival tumor tissue sample should be available for submission to the central laboratory prior to study treatment (36 months). If an archival tumor tissue sample is not available, a new biopsy tissue sample should be provided if feasible. 10. Patients who have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 11. Adequate organ and bone marrow function based upon meeting all of the following laboratory criteria: 1. Neutrophil count (ANC) ≥ 1,500/mm\^3 2. Platelet count ≥ 75 × 10\^9/L 3. Hemoglobin ≥ 8 g/dL 4. Serum bilirubin ≤ 1.5 × upper limit of normal (ULN) or ≤ 3 × ULN for subjects with Gilbert's disease or liver metastases 5. Creatinine clearance (CrCl) ≥ 40 mL/min as estimated by the Cockcroft-Gault formula or as measured by 24-hour urine collection (GFR can also be used instead of CrCl). Note: renal tract obstruction is not allowed. 6. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN or ≤ 5 x ULN for subjects with liver metastases 12. Female subject must provide a negative urine pregnancy test at screening, and must agree to use a medically accepted and highly effective birth control method (i.e. those with a failure rate less than 1%) for the duration of the study treatment and for 6 months after the final dose of study treatment. 13. Female patients must agree not to breastfeed or donate ovules starting at screening and throughout the study period, and for at least 6 months after the final study drug administration. 14. Male patients must agree not to donate sperm starting at screening and throughout the study period, and for at least 6 months after the final study drug administration. 15. Male patients with a pregnant or breastfeeding partner(s) must agree to abstinence or use a condom for the duration of the pregnancy or time the partner is breastfeeding throughout the study period and for at least 6 months after the final study drug administration. 16. Subject agrees not to participate in another interventional study while on treatment in the present study. Exclusion Criteria: 1. Patients who are not able to swallow tablets. 2. Patients with poorly-differentiated or high-grade neuroendocrine carcinoma (i.e. large cell neuroendocrine carcinoma of lung, small cell lung cancer) or mixed tumors (i.e. adenocarcinoid tumor) are not eligible. 3. Patients with brain mets unless stable on treatment for \> 12 weeks and with no evidence of raised intracranial pressure or mass effect. 4. Patients who have ongoing clinically significant toxicity (Grade 2 or higher with the exception of alopecia) associated with prior treatment (including systemic therapy, radiotherapy or surgery). 5. Patients who have a recent diagnosis of another malignancy (within 12 months prior to inclusion), patients who are on active treatment for other cancer before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. 6. Patients who have a known active Hepatitis B (e.g., HBsAg reactive) or active hepatitis C (e.g., hepatitis C virus (HCV) RNA \[qualitative\] is detected). Patients who have a known history of human immunodeficiency virus (HIV) infection (HIV 1 or 2). 7. Patients who have received a live vaccine up to 4 weeks prior to the first dose of trial treatment. Note:Live attenuated vaccines should not be administered during the trial treatment and over the next 3 months after the last treatment dose. 8. Patients who have documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms (including congestive heart failure) consistent with New York Heart Association Class III-IV within 6 months prior to the first dose of study drug. 9. Prior peptide receptor radionuclide therapy (PRRT) or mammalian target of rapamycin (mTOR) inhibitors (e.g. deforolimus, everolimus, sirolimus, temsirolimus, etc.); or hepatic radio-embolization (within 6 months prior to first dose of study treatment). 10. Prior radiotherapy or major surgery within 12 weeks prior to the first dose of study drug. 11. Patients who have had chemotherapy, biologics, investigational agents, and/or antitumor treatment with immunotherapy that is not completed 4 weeks prior to the first dose of study drug. 12. Patients who have known hypersensitivity to Everolimus or to any excipient contained in the drug formulation of Everolimus. 13. Patients who have known hypersensitivity to 177Lu-edotreotide or to any excipient contained in the drug formulation of 177Lu-edotreotide or the nephroprotective amino acid solution (AAS). 14. Current spontaneous urinary incontinence preventing safe administration of the investigational medicinal product (IMP), in the investigator's opinion. 15. Patients who have other underlying medical conditions that, in the opinion of the investigator, would impair the ability of the subject to receive or tolerate the planned treatment and follow-up.

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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 in 4 countries. 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

  • AOU Consorziale Policlinico di Bari - CROB Referrall Cancer Center of Basilicata

    RECRUITING

    Bari, 70124, Italy

  • Antwerp University Hospital (UZA)

    RECRUITING

    Edegem, Edegem, 2650, Belgium

  • Azienda Ospedaliera Universitaria Integrata Verona

    RECRUITING

    Verona, 37126, Italy

  • Azienda USL IRCCS Di Reggio Emilia

    RECRUITING

    Reggio Emilia, Reggio Emilia, 42123, Italy

  • CHU Liège

    RECRUITING

    Liège, 4000, Belgium

  • Centre Hospitalier Universitaire (CHU) Bordeux

    RECRUITING

    Bourdeaux, 33000, France

  • Centre Hospitalier Universitaire de Nantes

    RECRUITING

    Nantes, 44000, France

  • Complexo Hospitalario Universitario de Santiago de Compostela

    RECRUITING

    Santiago de Compostela, Galicia, 28042, Spain

  • Department of Digestive Oncology, CHU Saint Eloi, Montpellier, France/ ICM Cancer Institute at Montpellier

    RECRUITING

    Montpellier, 34090, France

  • Department of Nuclear Medicine, La Timone University Hospital, CERIMED, Aix-Marseille University, France

    RECRUITING

    Marseille, 13005, France

  • Digestive Disease Unit, Sant'Andrea University Hospital, ENETS Center of Excellence Rome, Rome, Italy.

    NOT_YET_RECRUITING

    Roma, 00189, Italy

  • Fundación Jiménez Díaz University Hospital

    RECRUITING

    Madrid, Madrid, 28040, Spain

  • Hospital Center University Dijon Bourgogne (CHU Bourgogne)

    RECRUITING

    Dijon, Dijon, 21079, France

  • Hospital General Universitario Gregorio Marañón

    RECRUITING

    Madrid, Madrid, 28007, Spain

  • Hospital Universitari Vall d'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, Madrid, 28041, Spain

  • Hospital Universitario Central de Asturias

    RECRUITING

    Oviedo, Principality of Asturias, 33011, Spain

  • Hospital Universitario Ramón y Cajal, Madrid

    RECRUITING

    Madrid, Madrid, 28034, Spain

  • Hospital Universitario Virgen del Rocío

    RECRUITING

    Seville, Andalusia, 41013, Spain

  • Hospital Universitario y Politécnico La Fe

    RECRUITING

    Valencia, Valencia, 46026, Spain

  • Hôpital Edouard Herriot, Lyon

    RECRUITING

    Lyon, 69003, France

  • I. Gustave Roussy, Paris

    RECRUITING

    Paris, 94805, France

  • ICO Institut Català d'Oncologia L'Hospitalet

    RECRUITING

    L'Hospitalet de Llobregat, Barcelona, 08908, Spain

  • IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - Irsì - Meldola

    RECRUITING

    Meldola, 47014, Italy

  • Istituto Europeo di Oncologia - Milano

    RECRUITING

    Milan, 20141, Italy

  • Lille University Hospital

    RECRUITING

    Lille, 59000, France

  • UCL Saint-Luc

    RECRUITING

    Brussels, 1200, Belgium

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