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Study to evaluate the efficacy and safety of [177Lu]Lu-DOTA-TATE in patients with Grade 1 and Grade 2 advanced GEP-NET (NETTER-3)
EU CTIS ID: 2024-518325-15-00
What this study is testing
To demonstrate that [177Lu]Lu-DOTA-TATE plus octreotide LAR is superior to active comparator in delaying the time-to-first occurrence of progression or death (PFS) as first line treatment.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Presence of metastasized or locally advanced, unresectable (curative intent), histologically proven, well differentiated G1 or G2 (Ki-67 <10%) GEP-NET diagnosed within 6 months prior to screening.
- Participants with high disease burden in the Investigator's opinion. Following criteria should be used as the guiding principle for determining high disease burden: • Primary tumor or a metastatic lesion > 4 cm • More than one tumor or metastatic lesions measuring > 2 cm • Elevated alkaline phosphatase > 2.5 X upper limit of normal (ULN) • Presence of bone metastasis • Presence of peritoneal metastasis • Symptoms due to tumor volume such as pain, fatigue, weight loss, anorexia etc. • Symptoms due to hormone excess requiring active management Additionally, participants who, in the Investigator's opinion, have high disease burden due to their disease characteristics not specified above could also be considered eligible. The clinical characteristics of the disease must be clearly recorded in the electronic case report form.
- Participants ≥ 12 years of age. For Germany, Hungary, The Netherlands and Poland, only adult participants ≥ 18 years of age will be enrolled.
- Radioligand imaging (RLI) SSTR uptake on all target lesions (defined by RECIST v1.1 criteria) at least as high as normal liver uptake, assessed within 3 months prior to randomization. Any of the RLI modalities such as, [68Ga]Ga-DOTA-TOC PET/CT or PET/MRI, [68Ga]Ga-DOTA-TATE PET/CT or PET/MRI, [64Cu]Cu-DOTA-TATE PET/CT or PET/MRI, somatostatin receptor scintigraphy (SRS) (planar and/or SPECT/CT) with [111In]In-pentetreotide, or SRS (planar and/or SPECT/CT) with [99mTc]Tc-octreotide, can be used as per local practice.
- Adequate bone marrow and organ function as defined by the following laboratory values prior to receiving the first study treatment: a. White blood cells (WBCs) ≥ 2 x 109/L* b. Platelet count ≥ 75 x 109/L* c. Hemoglobin ≥ 8 g/dL* d. Creatinine clearance > 40 mL/min calculated by the Cockcroft Gault method e. Total bilirubin ≤ 3 x ULN f. Potassium within normal limits. Potassium level of up to 6.0 millimoles per liter (mmol/L) is acceptable at study entry if associated with creatinine clearance withinr normal limits calculated using Cockcroft-Gault formula. Mild decrease (grade 1) below lower limit of normal (LLN) is acceptable at study entry if considered not clinically significant by Investigator. See details regarding potassium assessment and Lysine – Arginine amino acid solution administration in Section 8.4.4. *No platelet transfusion packed red cell transfusion, or granulocyte-colony stimulating factor (G-CSF) will be allowed during screening after ICF signature. Transfusion for the sole purpose of making a participant eligible for the study inclusion is not allowed.
- ECOG performance status 0-1.
You likely can't join if
- Prior administration of a therapeutic radiopharmaceutical for GEP-NET at any time prior to randomization in the study.
- Active severe urinary incontinence, severe voiding dysfunction, or urinary obstruction requiring an indwelling/condom catheter that, in the judgment of the Investigator, could prevent adhering to radiation safety instructions.
- Any previous therapy with interferons, mTOR-inhibitors, chemotherapy or other systemic therapies (except SSAs; please refer to exclusion criteria # 3 for further details) of GEP-NET. If as per Investigator opinion a participant is a candidate for such therapies, such participant must not be enrolled.
- Participant who received more than 4 cycles of prior SSA (e.g., octreotide LAR) are not eligible. In addition, any participant receiving treatment with short-acting octreotide, which cannot be interrupted for 24 h before the administration of [177Lu]Lu-DOTA-TATE, or any participant receiving treatment with SSAs, which cannot be interrupted for at least 4 weeks before the administration of [177Lu]Lu-DOTA-TATE.
- Documented RECIST v1.1 progression during previous SSA treatments for the current GEP-NET at any time prior to randomization.
- Any previous radioembolization, chemoembolization and radiofrequency ablation for GEP-NET
See the full eligibility criteria
Who can join
- Presence of metastasized or locally advanced, unresectable (curative intent), histologically proven, well differentiated G1 or G2 (Ki-67 <10%) GEP-NET diagnosed within 6 months prior to screening.
- Participants with high disease burden in the Investigator's opinion. Following criteria should be used as the guiding principle for determining high disease burden: • Primary tumor or a metastatic lesion > 4 cm • More than one tumor or metastatic lesions measuring > 2 cm • Elevated alkaline phosphatase > 2.5 X upper limit of normal (ULN) • Presence of bone metastasis • Presence of peritoneal metastasis • Symptoms due to tumor volume such as pain, fatigue, weight loss, anorexia etc. • Symptoms due to hormone excess requiring active management Additionally, participants who, in the Investigator's opinion, have high disease burden due to their disease characteristics not specified above could also be considered eligible. The clinical characteristics of the disease must be clearly recorded in the electronic case report form.
- Participants ≥ 12 years of age. For Germany, Hungary, The Netherlands and Poland, only adult participants ≥ 18 years of age will be enrolled.
- Radioligand imaging (RLI) SSTR uptake on all target lesions (defined by RECIST v1.1 criteria) at least as high as normal liver uptake, assessed within 3 months prior to randomization. Any of the RLI modalities such as, [68Ga]Ga-DOTA-TOC PET/CT or PET/MRI, [68Ga]Ga-DOTA-TATE PET/CT or PET/MRI, [64Cu]Cu-DOTA-TATE PET/CT or PET/MRI, somatostatin receptor scintigraphy (SRS) (planar and/or SPECT/CT) with [111In]In-pentetreotide, or SRS (planar and/or SPECT/CT) with [99mTc]Tc-octreotide, can be used as per local practice.
- Adequate bone marrow and organ function as defined by the following laboratory values prior to receiving the first study treatment: a. White blood cells (WBCs) ≥ 2 x 109/L* b. Platelet count ≥ 75 x 109/L* c. Hemoglobin ≥ 8 g/dL* d. Creatinine clearance > 40 mL/min calculated by the Cockcroft Gault method e. Total bilirubin ≤ 3 x ULN f. Potassium within normal limits. Potassium level of up to 6.0 millimoles per liter (mmol/L) is acceptable at study entry if associated with creatinine clearance withinr normal limits calculated using Cockcroft-Gault formula. Mild decrease (grade 1) below lower limit of normal (LLN) is acceptable at study entry if considered not clinically significant by Investigator. See details regarding potassium assessment and Lysine – Arginine amino acid solution administration in Section 8.4.4. *No platelet transfusion packed red cell transfusion, or granulocyte-colony stimulating factor (G-CSF) will be allowed during screening after ICF signature. Transfusion for the sole purpose of making a participant eligible for the study inclusion is not allowed.
- ECOG performance status 0-1.
- Presence of at least 1 measurable site of disease
What rules you out
- Prior administration of a therapeutic radiopharmaceutical for GEP-NET at any time prior to randomization in the study.
- Active severe urinary incontinence, severe voiding dysfunction, or urinary obstruction requiring an indwelling/condom catheter that, in the judgment of the Investigator, could prevent adhering to radiation safety instructions.
- Any previous therapy with interferons, mTOR-inhibitors, chemotherapy or other systemic therapies (except SSAs; please refer to exclusion criteria # 3 for further details) of GEP-NET. If as per Investigator opinion a participant is a candidate for such therapies, such participant must not be enrolled.
- Participant who received more than 4 cycles of prior SSA (e.g., octreotide LAR) are not eligible. In addition, any participant receiving treatment with short-acting octreotide, which cannot be interrupted for 24 h before the administration of [177Lu]Lu-DOTA-TATE, or any participant receiving treatment with SSAs, which cannot be interrupted for at least 4 weeks before the administration of [177Lu]Lu-DOTA-TATE.
- Documented RECIST v1.1 progression during previous SSA treatments for the current GEP-NET at any time prior to randomization.
- Any previous radioembolization, chemoembolization and radiofrequency ablation for GEP-NET
- Any major surgery within 12 weeks prior to randomization in the study.
- Known brain metastases.
- Participant with known intolerance to CT scans with i.v. contrast due to allergic reaction or renal insufficiency. If such a participant can be imaged with MRI, then the participant would not be excluded.
- Hypersensitivity to any somatostatin analogues, to the Investigational Medicinal Products (IMPs) active substance or to any of the excipients.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- United Kingdom
- Canada
- China
- Korea, Republic of
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 0-17 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; United Kingdom; Canada; China; Korea, Republic of. 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 EU CTIS; the study team decides eligibility.