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Testing Lutetium Lu 177 Dotatate in Patients With Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors

ConditionsAdvanced Lung Neuroendocrine TumorFunctioning Lung Neuroendocrine TumorLocally Advanced Lung Neuroendocrine NeoplasmLung Neuroendocrine NeoplasmLung Neuroendocrine Tumor G1Lung Neuroendocrine Tumor G2Metastatic Lung Neuroendocrine NeoplasmMetastatic Lung Neuroendocrine TumorNon-Functioning Lung Neuroendocrine TumorRecurrent Lung Neuroendocrine NeoplasmUnresectable Lung Neuroendocrine NeoplasmUnresectable Lung Neuroendocrine Tumor
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Cancer Institute (NCI)

About this trial

This phase II trial studies the effect of lutetium Lu 177 dotatate compared to the usual treatment (everolimus) in treating patients with somatostatin receptor positive bronchial neuroendocrine tumors that have spread to other places in the body (advanced). Lutetium Lu 177-dotate is a radioactive drug. It binds to a protein called somatostatin receptor, which is found on some neuroendocrine tumor cells. Lutetium Lu 177-dotatate builds up in these cells and gives off radiation that may kill them. It is a type of radioconjugate and a type of somatostatin analog. Lutetium Lu 177 dotatate may be more effective than everolimus in shrinking or stabilizing advanced bronchial neuroendocrine tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

PRE-REGISTRATION: Pathologic Documentation: Well- or moderately-differentiated neuroendocrine tumor(s) of bronchial origin (i.e. carcinoid) as assessed by local pathology

Well- or moderately-differentiated neuroendocrine tumor,

Low- or intermediate-grade neuroendocrine tumor, or

Carcinoid tumor (including typical or atypical carcinoid tumors)

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood and tissue sample collection

  • Computed Tomography

    Procedure/Surgery

    Undergo CT

  • Everolimus

    Drug

    Given PO

  • Fludeoxyglucose F-18

    Other intervention

    Given FDG

  • Lutetium Lu 177 Dotatate

    Drug

    Given IV

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET

  • Single Photon Emission Computed Tomography

    Procedure/Surgery

    Undergo SPECT

  • Survey Administration

    Other intervention

    Ancillary studies

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Arm I (lutetium Lu 177 dotatate)Experimental treatment 8 interventions
Group B: Arm II (everolimus)Active comparator 8 interventions

Trial outcomes

Primary outcomes

1

Median progression-free survival (PFS)

Will be compared between patients with a bronchial neuroendocrine tumor receiving lutetium Lu 177 dotatate to those receiving everolimus. The distribution of PFS will be estimated using the Kaplan Meier method. Will be tested using a one-sided stratified log rank test. The median PFS, along with 90% confidence intervals (CIs), will be estimated for the two treatment groups.

Time frame
From randomization until either radiographic progression confirmed by central radiology review or death, assessed up to 5 years from study registration

Secondary outcomes

1

Overall survival (OS)

The distribution of OS will be estimated using the method of Kaplan-Meier. The median OS, along with 90% CIs, will be estimated by the two treatment groups. OS will be compared between the two between treatment arms using the stratified log-rank test at a one-sided 10% level of significance.

Time frame
From randomization until death due to any cause, with patients censored at the last date known to be alive or last contact date, assessed up to 5 years from study registration
2

Overall response rate (ORR)

Defined as the proportion of patients in each arm whose best response is either complete response (CR) or partial response (PR). Will be estimated using point estimates and 95% CIs according to the methods in Duffy and Santner.

Time frame
Up to 5 years from study registration
3

Incidence of adverse events

Will evaluate and compare the toxicity profile of lutetium Lu 177 dotatate and everolimus. As per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0, the term toxicity is defined as adverse events that are classified as either possibly, probably, or definitely related to the study treatment.

Time frame
Up to 5 years from study registration

Other outcomes

1

Incidence of late toxicities of lutetium Lu 177 dotatate therapy

The incidence of grade 3+ late toxicities will be analyzed in a descriptive manner. Incidence will be described for each treatment arm. Frequency tables will be reviewed for patterns.

Time frame
More than 30 days after treatment
2

Pretreatment disease burden

Time frame
Baseline
3

Somatostatin receptor (SSTR) status on DOTATATE positron emission tomography (PET) (or other SSTR-PET)

Time frame
Up to 5 years from study registration
4

Dosimetry of response

Time frame
Up to 5 years from study registration

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Cancer Institute (NCI)

Lead sponsor

Source ClinicalTrials.gov
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