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Radioactive drug takes on standard therapy in lung cancer trial

NCT ID NCT04665739

Disease control Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Updated 19 times

Summary

This phase II trial tests whether a radioactive drug called lutetium Lu 177 dotatate works better than the usual drug everolimus for people with advanced bronchial neuroendocrine tumors (a type of lung cancer). The radioactive drug targets a protein on tumor cells and delivers radiation to kill them. About 70 participants will be randomly assigned to one of the two treatments, and researchers will compare how long the cancer stays under control.

What this could mean

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

Active substance
lutetium Lu 177 dotatate (a radioactive drug that targets tumor cells) and everolimus (a standard drug)
What this could lead to
If successful, this could offer a more effective treatment option for people with advanced bronchial neuroendocrine tumors, potentially slowing tumor growth better than current therapy.
What could go wrong
This is a phase II trial with only 70 participants, so results are preliminary. The radioactive drug may cause side effects like kidney or bone marrow damage, and it may not prove superior to 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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 70 people

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

Started

Feb 2023

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

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: * PRE-REGISTRATION: Pathologic Documentation: Well- or moderately-differentiated neuroendocrine tumor(s) of bronchial origin (i.e. carcinoid) as assessed by local pathology * The pathology report must state ONE of the following: * Well- or moderately-differentiated neuroendocrine tumor, * Low- or intermediate-grade neuroendocrine tumor, or * Carcinoid tumor (including typical or atypical carcinoid tumors) * PRE-REGISTRATION: Documentation of histology from a primary or metastatic site is allowed * PRE-REGISTRATION: Functional (evidence of peptide hormones and/or bioactive substances associated with a clinical hormone syndrome such as carcinoid syndrome or Cushing's syndrome) or nonfunctional tumors are allowed * PRE-REGISTRATION: 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 * PRE-REGISTRATION: Recurrent or locally-advanced/unresectable or metastatic disease * PRE-REGISTRATION: Neuroendocrine tumor of bronchial (i.e. lung) primary site * PRE-REGISTRATION: Lesions must have shown radiological evidence of disease progression in the 12 months prior to pre-registration * Tumor must have shown somatostatin receptor (SSTR) positivity on 68Ga-DOTATATE PET or other SSTR-PET scan in the 12 months prior to pre-registration; however, documentation of SSTR positivity in the 6 months prior to pre-registration is preferred. SSTR positivity is defined as uptake greater than background liver in all measurable lesions * PRE-REGISTRATION: Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 by computer tomography (CT) scan or magnetic imaging (MRI). Any lesions which have undergone percutaneous therapies or radiotherapy should not be considered measurable unless the lesion has clearly progressed since the procedure * PRE-REGISTRATION: Lesions must be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 1 cm with CT or MRI (or \>= 1.5 cm short axis for lymph nodes). Non-measurable disease includes disease smaller than these dimensions or lesions considered truly non-measurable including: leptomeningeal disease, bone metastases, ascites, pleural or pericardial effusion, lymphangitic involvement of skin or lung * REGISTRATION: Confirmation of SSTR positivity by Alliance Imaging Core Lab (ICL) at Imaging and Radiation Oncology Core (IROC) Ohio central radiographic review * REGISTRATION: Patients with treatment-naive or previously-treated disease are allowed. Patients with previously-treated disease must have demonstrated radiographic disease progression on the prior therapy * REGISTRATION: No prior treatment with peptide receptor radionuclide therapy (PRRT) (e.g. lutetium Lu 177 dotatate) * REGISTRATION: No prior treatment with mammalian target of rapamycin (mTOR) inhibitors (e.g. deforolimus, everolimus, sirolimus, temsirolimus, etc.) * REGISTRATION: Prior treatment with hepatic artery embolization (including bland embolization, chemoembolization, and selective radioembolization) or ablative therapies (i.e. cryoablation, radiofrequency ablation, etc.) is allowed if measurable disease remains outside of the treated area or if there is documented disease progression in a treated site. Prior liver-directed (including ablative) treatment must be completed at least 28 days prior to registration * REGISTRATION: Prior treatment with 90-Yttrium radioembolization must be completed at least 6-weeks prior to registration * REGISTRATION: Radiation therapy to the lung and/or mediastinum must be completed at least 14 days prior to registration for stereotactic ablative and at least 28 days prior to registration for conventional fractionation * REGISTRATION: Prior treatment with systemic anticancer therapy must be completed at least 28 days prior to registration (except for somatostatin analogs in patients with functional tumors). Continuation of treatment with somatostatin analogs while on protocol therapy is allowed provided that the patient: * Has functional tumors (evidence of peptide hormones and/or bioactive substances associated with a clinical hormone syndrome such as carcinoid syndrome or Cushing's syndrome), and * Has previously demonstrated radiographic disease progression while on somatostatin analog therapy * REGISTRATION: Patients must have completed any major surgery at least 28 days prior to registration. Complete wound healing from major surgery should occur prior to registration * REGISTRATION: Patients should have improvement of any toxic effects of prior therapy (except alopecia, fatigue, and other non-reversible toxic effects such as neuropathy from cisplatin) to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, grade 1 or less * REGISTRATION: Not pregnant and not nursing * Therefore, for women of childbearing potential only, a negative pregnancy test done =\< 28 days prior to registration is required * REGISTRATION: Age \>= 18 years * REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * REGISTRATION: Hemoglobin \>= 8.0 g/dL * REGISTRATION: Platelet count \>= 75,000/mm\^3 * REGISTRATION: Absolute neutrophil count (ANC) \>= 1,500/mm\^3 * REGISTRATION: Creatinine =\< 1.5 x upper limit of normal (ULN) OR calculated creatinine clearance \>= 40 mL/min * Calculated by the Cockcroft-Gault equation * REGISTRATION: Total bilirubin =\< 2.0 x ULN * In patients with Gilbert's syndrome, if total bilirubin is \> 2.0 x ULN, then direct bilirubin must be =\< 2.0 x ULN * REGISTRATION: Albumin \>= 2.8 g/dL * REGISTRATION: Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3.0 x ULN * REGISTRATION: No known central nervous system metastases unless treated and clinically stable for at least 14 days prior to registration. Patients on steroid support must be clinically stable on weaning doses of steroids * REGISTRATION: No other currently active malignancy that requires therapy or is expected to require therapy during the study (excluding non-melanoma skin cancers or in situ carcinomas, such as breast or cervical) * REGISTRATION: No known active hepatitis B (defined as hepatitis B surface antigen \[HbsAg\] reactive) or known active hepatitis C virus (defined as hepatitis C virus \[HCV\] ribonucleic acid \[RNA\] viral load detected). The exception is for patients with known active hepatitis B virus (defined as HbsAg reactive) infection, where the HBV viral load must be undetectable on suppressive therapy for patient to be eligible * REGISTRATION: Patients with known human immunodeficiency virus (HIV) infections on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial * REGISTRATION: No known active or uncontrolled infections requiring ongoing antifungals or antibiotics in the 3 days prior to registration * REGISTRATION: No receipt of live attenuated vaccines in the 7 days prior to registration * REGISTRATION: No known decompensated liver cirrhosis * REGISTRATION: No known prior drug-induced pneumonitis that was symptomatic or required treatment * REGISTRATION: No known medical condition causing an inability to swallow and no known impairment of gastrointestinal function that may significantly alter the absorption of an oral agent * REGISTRATION: No known hypersensitivity to everolimus or other rapamycin analogs (e.g. sirolimus, temsirolimus, etc.) * REGISTRATION: Concurrent somatostatin analog use while on protocol therapy is allowed provided that the patient: 1) has a functional tumor (evidence of peptide hormones and/or bioactive substances associated with a clinical hormone syndrome such as carcinoid syndrome or Cushing's syndrome), 2) has previously demonstrated radiographic disease progression while on somatostatin analog therapy * REGISTRATION: Chronic concomitant treatment with P-gp and strong CYP3A4 inhibitors and/or inducers is not allowed on the everolimus treatment arm of this study. Given that the study is randomized, all patients on P-gp and strong CYP3A4 inhibitors and/or inducers must discontinue the drug(s) 7 days prior to registration * RE-REGISTRATION: Confirmation of disease progression by RECIST v1.1 by real-time Alliance ICL at IROC Ohio central radiographic review * RE-REGISTRATION: Not pregnant and not nursing * Women of childbearing potential only, a negative pregnancy test done =\< 28 days prior to re-registration is required * RE-REGISTRATION: ECOG performance status 0-2 * RE-REGISTRATION: Hemoglobin \>= 8.0 g/dL * RE-REGISTRATION: Platelet count \>= 75,000/mm\^3 * RE-REGISTRATION: Absolute neutrophil count (ANC) \>= 1,500/mm\^3 * RE-REGISTRATION: Creatinine =\< 1.5 x upper limit of normal (ULN) OR calculated creatinine clearance \>= 40 mL/min * Calculated by the Cockcroft-Gault equation * RE-REGISTRATION: Total bilirubin =\< 2.0 x ULN * In patients with Gilbert's syndrome, if total bilirubin is \> 2.0 x ULN, then direct bilirubin must be =\< 2.0 x ULN * RE-REGISTRATION: Albumin \>= 2.8 g/dL * RE-REGISTRATION: AST/ALT =\< 3.0 x ULN

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Conditions

The condition(s) this trial relates to.

bronchial endocrine tumor lung neuroendocrine neoplasm

As listed by the trial registrant

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

Advanced lung neuroendocrine tumor Functioning lung neuroendocrine tumor Locally advanced lung neuroendocrine neoplasm Lung neuroendocrine neoplasm Lung neuroendocrine tumor G1 Lung neuroendocrine tumor G2 Metastatic lung neuroendocrine neoplasm Metastatic lung neuroendocrine tumor Non-functioning lung neuroendocrine tumor Recurrent lung neuroendocrine neoplasm Unresectable lung neuroendocrine neoplasm Unresectable lung neuroendocrine tumor

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. 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 ↗

  4. 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

  • Case Western Reserve University

    RECRUITING

    Cleveland, Ohio, 44106, United States

    Contact Email: •••••@•••••

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

    Contact Email: •••••@•••••

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Duke University Medical Center

    SUSPENDED

    Durham, North Carolina, 27710, United States

  • Fox Chase Cancer Center

    RECRUITING

    Philadelphia, Pennsylvania, 19111, United States

  • Huntsman Cancer Institute/University of Utah

    RECRUITING

    Salt Lake City, Utah, 84112, United States

    Contact Email: •••••@•••••

  • Iowa Methodist Medical Center

    RECRUITING

    Des Moines, Iowa, 50309, United States

  • Loma Linda University Medical Center

    SUSPENDED

    Loma Linda, California, 92354, United States

  • Mayo Clinic in Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • MedStar Georgetown University Hospital

    SUSPENDED

    Washington D.C., District of Columbia, 20007, United States

  • Missouri Baptist Medical Center

    RECRUITING

    St Louis, Missouri, 63131, United States

  • Ohio State University Comprehensive Cancer Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Temple University Hospital

    RECRUITING

    Philadelphia, Pennsylvania, 19140, United States

  • Torrance Memorial Physician Network - Cancer Care

    RECRUITING

    Torrance, California, 90505, United States

  • Tower Cancer Research Foundation

    RECRUITING

    Beverly Hills, California, 90211, United States

    Contact Email: •••••@•••••

  • UC Comprehensive Cancer Center at Silver Cross

    RECRUITING

    New Lenox, Illinois, 60451, United States

    Contact Email: •••••@•••••

  • UCSF Medical Center-Mission Bay

    RECRUITING

    San Francisco, California, 94158, United States

    Contact Email: •••••@•••••

  • UI Health Care Mission Cancer and Blood - Ankeny Clinic

    RECRUITING

    Ankeny, Iowa, 50023, United States

  • UI Health Care Mission Cancer and Blood - Des Moines Clinic

    RECRUITING

    Des Moines, Iowa, 50309, United States

  • UM Sylvester Comprehensive Cancer Center at Aventura

    SUSPENDED

    Aventura, Florida, 33180, United States

  • UM Sylvester Comprehensive Cancer Center at Coral Gables

    RECRUITING

    Coral Gables, Florida, 33146, United States

  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach

    RECRUITING

    Deerfield Beach, Florida, 33442, United States

  • UM Sylvester Comprehensive Cancer Center at Plantation

    RECRUITING

    Plantation, Florida, 33324, United States

  • UPMC Hillman Cancer Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Alabama at Birmingham Cancer Center

    WITHDRAWN

    Birmingham, Alabama, 35233, United States

  • University of Chicago Comprehensive Cancer Center

    RECRUITING

    Chicago, Illinois, 60637, United States

    Contact Email: •••••@•••••

  • University of Chicago Medicine-Orland Park

    RECRUITING

    Orland Park, Illinois, 60462, United States

    Contact Email: •••••@•••••

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    RECRUITING

    Miami, Florida, 33136, United States

  • Vanderbilt University/Ingram Cancer Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

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