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New treatment option for Advanced Lung Neuroendocrine Tumor
Official title Testing Lutetium Lu 177 Dotatate in Patients With Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors
ClinicalTrials.gov ID: NCT04665739
What this study is testing
What is Everolimus?
Everolimus is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for advanced lung neuroendocrine tumor.
Also referred to as 42-O-(2-Hydroxy)ethyl Rapamycin, Afinitor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 5 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- PRE-REGISTRATION: Pathologic Documentation: Well- or moderately-differentiated neuroendocrine tumor(s) of bronchial origin (i.e. carcinoid) as...
- 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)
See the full eligibility criteria
Who can join
- 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...
- 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: 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...
- 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...
- 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.)...
- 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...
- 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...
- 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 =\ = 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...
- 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...
- 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 assigned by chance, all patients...
- 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 =\ = 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
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Beverly Hills, California, United States
- Loma Linda, California, United States
- Los Angeles, California, United States
- San Francisco, California, United States
- Torrance, California, United States
- Washington D.C., District of Columbia, United States
- Aventura, Florida, United States
- Coral Gables, Florida, United States
- Deerfield Beach, Florida, United States
- Miami, Florida, United States
- Plantation, Florida, United States
- Chicago, Illinois, United States
- New Lenox, Illinois, United States
- Orland Park, Illinois, United States
- Ankeny, Iowa, United States
- Des Moines, Iowa, United States
- Boston, Massachusetts, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
+ 7 more site(s).
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Beverly Hills, California, United States; Loma Linda, California, United States; Los Angeles, California, United States; San Francisco, California, United States; Torrance, California, United States and 21 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.