CLINICAL TRIALS PROFILE FOR LUTETIUM LU 177 DOTATATE

All Clinical Trials for Lutetium Lu 177 Dotatate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02358356 ↗	Capecitabine ON Temozolomide Radionuclide Therapy Octreotate Lutetium-177 NeuroEndocrine Tumours Study	Unknown status	Australasian Gastro-Intestinal Trials Group	Phase 2	2015-11-01	Two parallel phase II randomized open label trials of Lutetium-177 Octreotate (177Lu-Octreotate) peptide receptor radionuclide therapy (PRRT) and capecitabine (CAP)/temozolomide (TEM) chemotherapy (chemo): (i) versus CAPTEM alone in the treatment of low to intermediate grade pancreatic neuroendocrine tumours (pNETs); (ii) versus PRRT alone in the treatment of low to intermediate grade mid gut neuroendocrine tumours (mNETs).
NCT02743741 ↗	Lu-DOTATATE Treatment in Patients With 68Ga-DOTATATE Somatostatin Receptor Positive Neuroendocrine Tumors	Recruiting	Canadian Molecular Imaging Probe Consortium	N/A	2016-07-01	This is a prospective single arm, multicenter study will evaluate the efficacy and safety of Lutetium-177 Octreotate in patients with neuroendocrine tumors who has positive Somatostatin receptor identified by 68Ga-DOTATATE. 195 patients will be enrolled totally. Patient who has progressed with neuroendocrine tumor will be evaluated by the tumor board first and eligible patients will undergo diagnostic Ga 68 PET scan. Patients who showed Somatostatin will undergo 4 cycles of Lu-DOTATATE treatment. Dose adjustment for Cycle 2-4 will be made based on individualized dosimetry, as well as creatinine clearance and hematological parameters. Patients will be evaluated progression free survival at 12 months from last dose. Patients who are negative for somatostatin will not receive 68Ga-DOTATATE treatment but will be followed until progression and acts as control group.
NCT02743741 ↗	Lu-DOTATATE Treatment in Patients With 68Ga-DOTATATE Somatostatin Receptor Positive Neuroendocrine Tumors	Recruiting	Cancer Care Ontario	N/A	2016-07-01	This is a prospective single arm, multicenter study will evaluate the efficacy and safety of Lutetium-177 Octreotate in patients with neuroendocrine tumors who has positive Somatostatin receptor identified by 68Ga-DOTATATE. 195 patients will be enrolled totally. Patient who has progressed with neuroendocrine tumor will be evaluated by the tumor board first and eligible patients will undergo diagnostic Ga 68 PET scan. Patients who showed Somatostatin will undergo 4 cycles of Lu-DOTATATE treatment. Dose adjustment for Cycle 2-4 will be made based on individualized dosimetry, as well as creatinine clearance and hematological parameters. Patients will be evaluated progression free survival at 12 months from last dose. Patients who are negative for somatostatin will not receive 68Ga-DOTATATE treatment but will be followed until progression and acts as control group.
NCT02743741 ↗	Lu-DOTATATE Treatment in Patients With 68Ga-DOTATATE Somatostatin Receptor Positive Neuroendocrine Tumors	Recruiting	Ozmosis Research Inc.	N/A	2016-07-01	This is a prospective single arm, multicenter study will evaluate the efficacy and safety of Lutetium-177 Octreotate in patients with neuroendocrine tumors who has positive Somatostatin receptor identified by 68Ga-DOTATATE. 195 patients will be enrolled totally. Patient who has progressed with neuroendocrine tumor will be evaluated by the tumor board first and eligible patients will undergo diagnostic Ga 68 PET scan. Patients who showed Somatostatin will undergo 4 cycles of Lu-DOTATATE treatment. Dose adjustment for Cycle 2-4 will be made based on individualized dosimetry, as well as creatinine clearance and hematological parameters. Patients will be evaluated progression free survival at 12 months from last dose. Patients who are negative for somatostatin will not receive 68Ga-DOTATATE treatment but will be followed until progression and acts as control group.
NCT02743741 ↗	Lu-DOTATATE Treatment in Patients With 68Ga-DOTATATE Somatostatin Receptor Positive Neuroendocrine Tumors	Recruiting	University Health Network, Toronto	N/A	2016-07-01	This is a prospective single arm, multicenter study will evaluate the efficacy and safety of Lutetium-177 Octreotate in patients with neuroendocrine tumors who has positive Somatostatin receptor identified by 68Ga-DOTATATE. 195 patients will be enrolled totally. Patient who has progressed with neuroendocrine tumor will be evaluated by the tumor board first and eligible patients will undergo diagnostic Ga 68 PET scan. Patients who showed Somatostatin will undergo 4 cycles of Lu-DOTATATE treatment. Dose adjustment for Cycle 2-4 will be made based on individualized dosimetry, as well as creatinine clearance and hematological parameters. Patients will be evaluated progression free survival at 12 months from last dose. Patients who are negative for somatostatin will not receive 68Ga-DOTATATE treatment but will be followed until progression and acts as control group.
NCT03590119 ↗	Intra-arterial Lutetium-177-dotatate for Treatment of Patients With Neuro-endocrine Tumor Liver Metastases	Recruiting	Marnix Lam	Phase 2/Phase 3	2018-08-01	The objective is to investigate the impact of intra-arterial administration of 177Lu-dotatate on the intrahepatic biodistribution in patients with NET liver metastases. Our primary objective is to evaluate if there is a difference in post-treatment tumor-to-non-tumor (T/N) activity concentration ratio on SPECT/CT between the intra-arterial treated liver lobe and the intravenous treated liver lobe.
NCT04082520 ↗	Lutathera for the Treatment of Inoperable, Progressive Meningioma After External Beam Radiation Therapy	Recruiting	National Cancer Institute (NCI)	Phase 2	2020-03-10	This phase II trial studies how well lutathera works in treating patients with meningioma that cannot be treated with surgery (inoperable) and is growing, spreading, or getting worse (progressive) after external beam radiation therapy. Lutathera is a radioactive drug administered in the vein that is designed to target and kill cancer cells. The goal of this study is to determine whether this drug is safe and effective in treating meningiomas that progress after radiation treatment.

Clinical Trial Conditions for Lutetium Lu 177 Dotatate

Condition Name

Condition Name for Lutetium Lu 177 Dotatate
Intervention	Trials
Neuroendocrine Tumors	6
Recurrent Meningioma	2
Digestive System Neuroendocrine Tumor	2
Metastatic Pancreatic Neuroendocrine Tumor	2

Condition MeSH

Condition MeSH for Lutetium Lu 177 Dotatate
Intervention	Trials
Neuroendocrine Tumors	15
Neoplasms	8
Carcinoid Tumor	4
Carcinoma	3

Clinical Trial Locations for Lutetium Lu 177 Dotatate

Trials by Country

Trials by Country for Lutetium Lu 177 Dotatate
Location	Trials
United States	34
Australia	4
Netherlands	1
Canada	1
India	1

Trials by US State

Trials by US State for Lutetium Lu 177 Dotatate
Location	Trials
Ohio	3
Massachusetts	3
Kentucky	3
California	3
Texas	3

Clinical Trial Progress for Lutetium Lu 177 Dotatate

Clinical Trial Phase

Clinical Trial Phase for Lutetium Lu 177 Dotatate
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	1
PHASE2	1

Clinical Trial Status

Clinical Trial Status for Lutetium Lu 177 Dotatate
Clinical Trial Phase	Trials
Recruiting	12
Not yet recruiting	9
Unknown status	1

Clinical Trial Sponsors for Lutetium Lu 177 Dotatate

Sponsor Name

Sponsor Name for Lutetium Lu 177 Dotatate
Sponsor	Trials
National Cancer Institute (NCI)	12
RayzeBio, Inc.	2
Novartis	2

Sponsor Type

Sponsor Type for Lutetium Lu 177 Dotatate
Sponsor	Trials
Other	20
NIH	13
Industry	10

Clinical Trials Update, Market Analysis, and Projection for Lutetium Lu 177 Dotatate

Last updated: October 28, 2025

Introduction

Lutetium Lu 177 dotatate (sold under brand names such as Lutathera) has emerged as a leading radiopharmaceutical in the therapeutic landscape for neuroendocrine tumors (NETs). Its approval by regulatory agencies has marked a pivotal advancement in targeted radionuclide therapy. This comprehensive analysis synthesizes recent clinical developments, evaluates current market dynamics, and projects future growth trajectories for Lutetium Lu 177 dotatate.

Clinical Trials Update

Summary of Recent and Ongoing Clinical Trials

Lutetium Lu 177 dotatate’s clinical development primarily hinges on the NETTER-1 trial (NCT02502484), a pivotal phase 3 study conducted by the University of Heidelberg. The trial demonstrated that patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) experienced significant progression-free survival (PFS) benefits with Lutathera plus standard care over placebo (hazard ratio: 0.21; p<0.001).

Following NETTER-1, the regulatory approval came in 2018 across the U.S. and Europe, cementing its therapeutic role. Post-approval, additional trials evaluate Lutathera's efficacy in other NET segments, such as bronchial and pancreatic neuroendocrine tumors. An ongoing phase 2 trial, NCT04106486, investigates Lutathera's efficacy in adrenergic tumors, with preliminary data indicating promising responses.

Emerging Therapeutic Combinations and Extended Indications

Recent trials focus on combination therapies. For instance, NCT04557598 assesses Lutathera with everolimus, targeting cases resistant to monotherapy. These trials aim to broaden applications beyond somatostatin receptor-positive NETs, potentially encompassing higher-grade or more aggressive variants.

Moreover, efforts are underway to establish laelder, longer-term safety and efficacy data. The NETTER-2 trial (NCT03972488), a phase 3 study, evaluates Lutathera in front-line settings for high-grade NETs, with initial endpoints suggesting improved PFS over standard therapies.

Safety Profiles and Adverse Event Monitoring

Clinical data affirm Lutathera's relatively favorable safety profile, with manageable side effects. Hematologic toxicities (e.g., thrombocytopenia) and transient gastrointestinal symptoms remain prevalent. Ongoing surveillance in post-marketing studies continues to reinforce its safety in broader patient populations.

Market Analysis

Current Market Landscape

Since its FDA approval in 2018, Lutathera has experienced rapid adoption worldwide. The global radiopharmaceuticals market, estimated at around USD 4 billion in 2022 with a compound annual growth rate (CAGR) of 7%, reflects increasing demand for targeted therapies[1]. Lutathera’s market share in the neuroendocrine tumor segment is dominant, owing to its innovative mechanism and demonstrated efficacy.

Key players include Novartis, which commercializes Lutathera, backed by a robust distribution network. The drug's reimbursement pathways in major markets like the U.S., Europe, and Japan have facilitated market penetration, though some regions face reimbursement hurdles affecting adoption rates.

Market Drivers

• Increased Diagnosis of NETs: Advances in imaging—such as Ga-68 DOTATATE PET scans—have improved detection, expanding eligible patient populations.
• Regulatory Approvals & Expanded Indications: Ongoing trials for broader indications may enlarge the target demographic.
• Clinical Efficacy & Safety Profile: Positive trial results boost clinician confidence and patient acceptance.

Market Challenges

• Manufacturing Complexity: Production of lutetium-177 radiolabeled compounds involves specialized facilities, limiting supply scalability.
• Reimbursement and Cost: High treatment costs (~USD 100,000 per course) pose access barriers, with reimbursement landscapes varying.
• Competition: Emerging therapies, including peptide receptor radionuclide therapy (PRRT) variants and other targeted treatments, threaten Lutathera's market dominance.

Competitive Landscape

While currently the leader, Lutathera faces competition from alternative radiopharmaceuticals such as:

• Alpha-emitter therapies (e.g., actinium-225-based treatments)
• Emerging peptide receptor antagonists with higher receptor affinity
• Chemotherapy and targeted agents (e.g., everolimus, sunitinib)

Next-generation radioligand therapies and combination regimens are poised to challenge existing treatment paradigms.

Market Projection and Future Outlook

Forecast Overview

Analysts project the global Lutetium Lu 177 dotatate market to reach USD 2.5 billion by 2030, growing at a CAGR of approximately 8% from 2023 onward[2]. The growth is driven by increasing diagnosis rates, expanded clinical indications, and ongoing clinical trial success.

Key Growth Segments

• Expansion into New Indications: Trials exploring use in higher-grade or non-isolated NETs can significantly enlarge the target population.
• Geographic Expansion: Adoption in emerging markets, where radiation-based therapies are gaining acceptance, will be pivotal.
• Combination Therapies: Integrating Lutathera with immunotherapies or targeted agents can improve outcomes, fostering higher demand.

Regulatory & Scientific Advances Impacting Growth

• Regulatory Approvals: Positive trial outcomes could lead to label extensions, bolstering revenues.
• Technological Innovations: Advances in radionuclide delivery and manufacturing efficiencies will reduce costs and enhance access.
• Personalized Medicine: Diagnostics refining patient selection will optimize treatment efficacy, further supporting market expansion.

Potential Risks and Uncertainties

• Therapeutic Resistance: Development of resistant tumor phenotypes may limit long-term efficacy.
• Market Saturation: Competition and patent expirations could influence pricing strategies.
• Regulatory Delays: Clinical trial setbacks or regulatory issues could hinder expansion plans.

Key Takeaways

• Lutetium Lu 177 dotatate has demonstrated robust clinical efficacy in NETs, with ongoing trials expanding its therapeutic scope.
• The global market for Lutathera is poised for sustained growth, driven by improved detection, clinical validation, and expanding indications.
• Manufacturing complexity and high treatment costs remain significant barriers, necessitating strategic investments in production and reimbursement negotiations.
• Future growth hinges on successful clinical trials exploring combination therapies, off-label uses, and regulatory approvals for new indications.
• Competitive dynamics, technological advances, and regulatory developments will shape the market landscape through 2030.

FAQs

1. What are the main indications for Lutetium Lu 177 dotatate?
   Currently approved primarily for somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), with ongoing trials evaluating its efficacy in other NET types and higher-grade tumors.

2. How does Lutathera compare to other radionuclide therapies?
   Lutathera is distinguished by its targeted mechanism, use of lutetium-177, and proven efficacy in clinical trials. Alternative therapies, like alpha-emitter radiotherapies, are under development but not yet mainstream.

3. What are the key safety concerns associated with Lutathera?
   Hematologic toxicities, including thrombocytopenia and leukopenia, are most common, generally manageable. Renal toxicity is rare but monitored due to radiation exposure.

4. What factors could influence Lutetium Lu 177 dotatate's market growth?
   Clinical trial results, regulatory approvals, reimbursement policies, manufacturing capacity, and competition from novel therapies.

5. When could we expect new indications or approvals for Lutathera?
   Pending positive trial outcomes, regulatory submissions could occur within the next 2-4 years, potentially expanding indications for high-grade or non-GEP NETs.

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Sources

[1] Grand View Research, "Radiopharmaceuticals Market Size, Share & Trends Analysis," 2022.
[2] MarketsandMarkets, "Theranostics Market by Type, Targeted Disease Indication, and Region," 2023.