Radioactive drug takes on standard therapy for rare lung and thymus cancers
NCT ID NCT05918302
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 170 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2023
- Expected to finish
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Oct 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
27 sites in 4 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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AOU Consorziale Policlinico di Bari - CROB Referrall Cancer Center of Basilicata
RECRUITINGBari, 70124, Italy
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Antwerp University Hospital (UZA)
RECRUITINGEdegem, Edegem, 2650, Belgium
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Azienda Ospedaliera Universitaria Integrata Verona
RECRUITINGVerona, 37126, Italy
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Azienda USL IRCCS Di Reggio Emilia
RECRUITINGReggio Emilia, Reggio Emilia, 42123, Italy
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CHU Liège
RECRUITINGLiège, 4000, Belgium
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Centre Hospitalier Universitaire (CHU) Bordeux
RECRUITINGBourdeaux, 33000, France
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Centre Hospitalier Universitaire de Nantes
RECRUITINGNantes, 44000, France
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Complexo Hospitalario Universitario de Santiago de Compostela
RECRUITINGSantiago de Compostela, Galicia, 28042, Spain
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Department of Digestive Oncology, CHU Saint Eloi, Montpellier, France/ ICM Cancer Institute at Montpellier
RECRUITINGMontpellier, 34090, France
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Department of Nuclear Medicine, La Timone University Hospital, CERIMED, Aix-Marseille University, France
RECRUITINGMarseille, 13005, France
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Digestive Disease Unit, Sant'Andrea University Hospital, ENETS Center of Excellence Rome, Rome, Italy.
NOT_YET_RECRUITINGRoma, 00189, Italy
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Fundación Jiménez Díaz University Hospital
RECRUITINGMadrid, Madrid, 28040, Spain
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Hospital Center University Dijon Bourgogne (CHU Bourgogne)
RECRUITINGDijon, Dijon, 21079, France
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Hospital General Universitario Gregorio Marañón
RECRUITINGMadrid, Madrid, 28007, Spain
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Hospital Universitari Vall d'Hebron
RECRUITINGBarcelona, 08035, Spain
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Hospital Universitario 12 de Octubre
RECRUITINGMadrid, Madrid, 28041, Spain
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Hospital Universitario Central de Asturias
RECRUITINGOviedo, Principality of Asturias, 33011, Spain
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Hospital Universitario Ramón y Cajal, Madrid
RECRUITINGMadrid, Madrid, 28034, Spain
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Hospital Universitario Virgen del Rocío
RECRUITINGSeville, Andalusia, 41013, Spain
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Hospital Universitario y Politécnico La Fe
RECRUITINGValencia, Valencia, 46026, Spain
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Hôpital Edouard Herriot, Lyon
RECRUITINGLyon, 69003, France
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I. Gustave Roussy, Paris
RECRUITINGParis, 94805, France
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ICO Institut Català d'Oncologia L'Hospitalet
RECRUITINGL'Hospitalet de Llobregat, Barcelona, 08908, Spain
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IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - Irsì - Meldola
RECRUITINGMeldola, 47014, Italy
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Istituto Europeo di Oncologia - Milano
RECRUITINGMilan, 20141, Italy
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Lille University Hospital
RECRUITINGLille, 59000, France
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UCL Saint-Luc
RECRUITINGBrussels, 1200, Belgium
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Swiss registry aims to map rare neuroendocrine tumors
- Can patients drop monthly injections after targeted radiotherapy for neuroendocrine tumors?
- Can a vast image library unlock better pancreatic diagnoses?
- Can a sharper PET tracer light up hidden neuroendocrine tumors?
- Can patient records reveal who will respond to neuroendocrine tumor treatments?
- Can a new drug formulation shrink Hard-to-Treat neuroendocrine tumors?