CLINICAL TRIALS PROFILE FOR LUTATHERA

All Clinical Trials for LUTATHERA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01578239 ↗	A Study Comparing Treatment With 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in Patients With Inoperable, Progressive, Somatostatin Receptor Positive Midgut Carcinoid Tumours	Completed	Pierrel Research Europe GmbH	Phase 3	2012-09-06	This was a multicenter, stratified, open, randomized, comparator-controlled, parallel-group phase III study comparing treatment with Lutathera plus best supportive care (30 mg Octreotide LAR) to treatment with high dose (60 mg) Octreotide LAR in participants with metastasized or locally advanced, inoperable, somatostatin receptor positive, histologically proven midgut carcinoid tumours with progression despite LAR treatment.
NCT01578239 ↗	A Study Comparing Treatment With 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in Patients With Inoperable, Progressive, Somatostatin Receptor Positive Midgut Carcinoid Tumours	Completed	Advanced Accelerator Applications	Phase 3	2012-09-06	This was a multicenter, stratified, open, randomized, comparator-controlled, parallel-group phase III study comparing treatment with Lutathera plus best supportive care (30 mg Octreotide LAR) to treatment with high dose (60 mg) Octreotide LAR in participants with metastasized or locally advanced, inoperable, somatostatin receptor positive, histologically proven midgut carcinoid tumours with progression despite LAR treatment.
NCT01876771 ↗	A Trial to Assess the Safety and Effectiveness of Lutetium-177 Octreotate Therapy in Neuroendocrine Tumours	Recruiting	AHS Cancer Control Alberta	Phase 2	2014-04-29	Neuroendocrine tumours (NETs) are rare, slow growing, and diagnosis is often delayed with advanced metastases at presentation. In select patient populations, radioisotope therapy with Lutetium-177 (Lu-DOTA-TATE) has been shown to be a safe and effective palliative therapy, and has been widely used by research groups in Europe. A brand of Lu-DOTA-TATE (Lutathera(R)) is approved for the treatment of gastroenteropancreatic NETs in Europe, the U.S., and more recently in Canada. While Lutathera(R) is approved in Canada, it is not publicly funded in Alberta. Lu-DOTA-TATE has been used at the Cross Cancer Institute to treat more than 300 patients with NETs since August, 2010. Our Lu-DOTA-TATE treatment was initially given under Health Canada's Special Access Programme (SAP), with each individual treatment requiring separate approval. In 2014, Health Canada requested we conduct a clinical trial with Lu-DOTA-TATE instead. The purpose of this study is to: 1) assess the efficacy of Lu-DOTA-TATE treatment in patients with somatostatin receptor positive tumours; 2) assess the safety of Lu-DOTA-TATE; 3) assess the effect of Lu-DOTA-TATE on Quality of Life and survival.
NCT02705313 ↗	EAP 177Lu-DOTA0-Tyr3-Octreotate for Inoperable, SSR+, NETs, Progressive Under SSA Tx	Approved for marketing	Advanced Accelerator Applications		1969-12-31	Advanced Accelerator Applications is currently pursuing marketing approval for 177Lu-DOTA0-Tyr3-Octreotate (Lutathera). This expanded access therapeutic protocol aims to allow patients suffering from inoperable, somatostatin receptor positive, neuroendocrine tumors, progressive under somatostatin analogue therapy to access the investigational product, 177Lu-DOTA0-Tyr3-Octreotate (Lutathera), prior to its commercial availability.
NCT03206060 ↗	Lu-177-DOTATATE (Lutathera) in Therapy of Inoperable Pheochromocytoma/ Paraganglioma	Recruiting	National Cancer Institute (NCI)	Phase 2	2017-10-10	Background: Pheochromocytoma and paraganglioma are rare tumors. They usually form inside and near the adrenal gland or in the neck region. Not all these tumors can be removed with surgery, and there are no good treatments if the disease has spread. Researchers think a new drug may be able to help. Objective: To learn the safety and tolerability of Lu-177-DOTATATE. Also, to see if it improves the length of time it takes for the cancer to return. Eligibility: Adults who have an inoperable tumor of the study cancer that can be detected with Ga-68-DOTATATE PET/CT imaging Design: Participants will be screened with a medical history, physical exam, and blood tests. Eligible participants will be admitted to the NIH Clinical Center. Participants will get the study drug in an intravenous infusion. They will get 4 doses, given about 8 weeks apart. Between 4 and 24 hours after each study drug dose, participants will have scans taken. They will lie on their back on a scanner table. Participants will have vital signs taken. They will give blood and urine samples. During the study, participants will have other scans taken. Some scans will use a radioactive tracer. Participants will complete quality of life questionnaires. Participants will be contacted by phone 1-3 days after they leave the Clinical Center. They will then be followed every 3 to 6 months for 3 years or until their disease gets worse.
NCT03325816 ↗	Nivolumab and 177Lu-DOTA0-Tyr3-Octreotate for Patients With Extensive-Stage Small Cell Lung Cancer	Completed	Advanced Accelerator Applications	Phase 1/Phase 2	2017-11-20	This research study is being done to assess the safety and tolerability of study drugs, 177Lu-DOTA0-Tyr3-Octreotate (Lutathera) and nivolumab in subjects with small cell lung cancer or advanced or inoperable neuroendocrine tumor of the lung that has overexpressed somatostatin receptors (SSRT). Lutathera is an investigational radioactive agent that targets tumor cells that express SSRT. Nivolumab is an investigational agent that targets and inhibits a pathway that prevents your immune system from effectively fighting your cancer. The combination of these 2 study drugs is investigational. The term "Investigational" in this context means that the drugs have not been approved for clinical use by the US Food and Drug Administration (FDA). Giving Lutathera and nivolumab together may increase the effectiveness of this therapy. We first need to find out the highest dose of Lutathera that can be given safely together with nivolumab. This study will be the first study to test giving Lutathera together with nivolumab. Once we have found the highest dose of Lutathera that can be given with nivolumab, we will treat more patients with this combination to determine how effective it is. The purposes of this study are: To find the highest doses of Lutathera that can be given with nivolumab without causing severe side effects. To find out the side effects seen by giving Lutathera at different dose levels with nivolumab. To determine if the amount of something in your tumor called PD-L1 makes you more likely to have a response to the combination of Lutathera and nivolumab.

Clinical Trial Conditions for LUTATHERA

Condition Name

Condition Name for LUTATHERA
Intervention	Trials
Neuroendocrine Tumors	16
Paraganglioma	5
Pheochromocytoma	5
Liver Metastases	3

Condition MeSH

Condition MeSH for LUTATHERA
Intervention	Trials
Neuroendocrine Tumors	32
Neoplasms	12
Pheochromocytoma	7
Paraganglioma	7

Clinical Trial Locations for LUTATHERA

Trials by Country

Trials by Country for LUTATHERA
Location	Trials
United States	81
Italy	11
France	11
United Kingdom	6
Spain	5

Trials by US State

Trials by US State for LUTATHERA
Location	Trials
Iowa	7
Texas	6
Pennsylvania	5
Ohio	5
Minnesota	5

Clinical Trial Progress for LUTATHERA

Clinical Trial Phase

Clinical Trial Phase for LUTATHERA
Clinical Trial Phase	Trials
PHASE3	1
PHASE2	4
Phase 4	1

Clinical Trial Status

Clinical Trial Status for LUTATHERA
Clinical Trial Phase	Trials
Not yet recruiting	21
Recruiting	20
Completed	2

Clinical Trial Sponsors for LUTATHERA

Sponsor Name

Sponsor Name for LUTATHERA
Sponsor	Trials
National Cancer Institute (NCI)	12
Advanced Accelerator Applications	11
Novartis Pharmaceuticals	3

Sponsor Type

Sponsor Type for LUTATHERA
Sponsor	Trials
Other	38
Industry	23
NIH	13

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

Last updated: October 30, 2025

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Introduction

Lutathera (Lutetium Lu 177 Dotatate) has emerged as a groundbreaking radiopharmaceutical for the targeted treatment of neuroendocrine tumors (NETs). Approved by the U.S. Food and Drug Administration (FDA) in 2018 and subsequent regulatory authorities worldwide, Lutathera exploits peptide receptor radionuclide therapy (PRRT) to deliver targeted radiation therapy to somatostatin receptor-positive tumors. This document provides a comprehensive overview of recent clinical trial developments, an analysis of the market landscape, and future projections for Lutathera.

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Clinical Trials Update

Recent and Ongoing Clinical Trials

Since its initial approval, Lutathera has continued to undergo rigorous clinical evaluation to expand its indications and optimize therapeutic protocols.

• NETTER-2 Trial (Phase 3): Launched in 2020, this pivotal trial evaluates Lutathera in combination with newer radiosensitizers or chemotherapeutic agents for advanced gastrointestinal neuroendocrine tumors (GI-NETs). Preliminary results, presented at major oncology conferences, suggest an improvement in progression-free survival (PFS) over standard therapies.

• Lutetium-177 DOTATATE for Pancreatic NETs: Multiple phase 2 studies are underway, assessing safety and efficacy in pancreatic neuroendocrine tumors (pNETs). Early data point to promising response rates with manageable toxicity profiles.

• Combination Therapy Trials: Several early-phase studies are exploring Lutathera alongside immune checkpoint inhibitors, such as PD-1/PD-L1 inhibitors, aiming to enhance immune-mediated tumor destruction. While still in the initial stages, these investigations indicate potential avenues for expanding Lutathera’s application.

Regulatory and Clinical Adoption Trends

• Expanded Indications: Regulatory bodies including the European Medicines Agency (EMA) are evaluating expanded uses of Lutathera for other somatostatin receptor-positive entities, including broncho-pulmonary carcinoids.

• Real-World Evidence (RWE): Registries and observational studies are accumulating data on Lutathera’s performance outside clinical trials, reinforcing its safety and effectiveness. In particular, improvements in quality of life and symptomatic relief have been consistently reported.

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Market Analysis

Current Market Size

Lutathera's initial commercial success reflects the significant unmet need in advanced NETs, which are rare but often incurable with conventional therapies. The global NET therapeutics market was valued at approximately USD 1.2 billion in 2022, with radiopharmaceuticals accounting for roughly 35% of this segment [1].

Key Market Drivers

• High Efficacy and Favorable Safety Profile: Lutathera’s targeted approach results in durable responses and a tolerable side-effect profile, fostering clinician and patient acceptance.

• Regulatory Approvals and Reimbursement: Post-approval, favorable reimbursement pathways have facilitated broad adoption across North America and Europe.

• Expanding Indications: Ongoing trials for pancreatic and other NET subsets are likely to diversify Lutathera’s applicability, further expanding its market share.

Competitive Landscape

While Lutathera currently dominates the radiopharmaceutical treatment of NETs, competitors are emerging:

• Alternative PRRTs: Such as Sanofi's Solucin (Lutetium-177 Edotreotide), although limited in global approval.

• Non-Radioactive Therapies: Targeted therapies like everolimus and sunitinib remain mainstays for certain NETs, but lack the specificity of Lutathera.

• Upcoming Radiopharmaceuticals: New candidates targeting different receptor pathways, such as alpha-emitting radionuclides, are under development.

Market Challenges

• Manufacturing and Supply: The complexity of radiolabeling processes and isotope logistics can constrain supply chains.

• Therapeutic Penetration in Developing Markets: High costs and infrastructure limitations hinder access in lower-income regions.

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Market Projection

Growth Forecasts

The market for Lutathera and analogous radiopharmaceuticals is projected to grow at a compound annual growth rate (CAGR) of approximately 12% from 2023 to 2030 [2]. The key growth catalysts include:

• Regulatory Approvals for Broader Indications: The success of clinical trials could lead to expanded uses in other somatostatin receptor-positive tumors.

• Increasing Global Diagnostics and Screening: Advances in imaging, such as Ga-68 PET, enhance detection of suitable candidates, fueling therapeutic demand.

• Technological Innovations: Improved radionuclide production and delivery techniques are lowering costs and increasing accessibility.

Market Penetration Strategies

Manufacturers and stakeholders should focus on:

• Expanding Clinical Evidence: To convince regulators and payers of Lutathera’s utility in new indications.

• Improving Logistics: Streamlining isotope supply chains will facilitate wider distribution.

• Cost Optimization: To improve affordability in emerging markets and increase patient access.

Future Opportunities

Emerging research indicates potential for Lutathera in treating small cell lung carcinoma and other receptor-positive malignancies. Moreover, ongoing trials with combination therapies could unlock synergistic effects, broadening clinical applications and market opportunities.

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Key Takeaways

• Robust Clinical Pipeline: Lutathera continues to undergo pivotal studies aiming to expand indications and optimize therapeutic outcomes, indicating sustained clinical interest.

• Market Leadership: As the first approved PRRT for NETs, Lutathera commands a substantial share of the radiopharmaceutical oncology market, with growth driven by positive clinical outcomes and regulatory support.

• Expansion Potential: Pending successful trial results, Lutathera’s label might extend to additional tumor types, further increasing sales and healthcare impact.

• Access Challenges and Opportunities: Manufacturing complexities and high costs present barriers, yet technological advances and licensing strategies can mitigate these issues.

• Competitive Dynamics: While Lutathera holds a dominant position, alternative therapies and upcoming innovations necessitate continuous differentiation and evidence generation.

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FAQs

1. What are the primary clinical advantages of Lutathera over conventional therapies for neuroendocrine tumors?
Lutathera offers targeted radiation delivery, resulting in higher tumor response rates, prolonged progression-free survival, and a favorable safety profile compared to traditional chemotherapies.

2. Which new indications are currently being explored in clinical trials for Lutathera?
Trials are evaluating its efficacy in pancreatic neuroendocrine tumors, bronchial carcinoids, and potential combination therapies involving immunotherapy agents.

3. How does Lutathera’s manufacturing process impact its market availability?
The production involves complex radiolabeling of lutetium-177, requiring specialized facilities and isotope supply chains. These factors influence manufacturing capacity and global distribution.

4. What is the outlook for Lutathera in emerging markets?
Market penetration may be limited initially due to costs and infrastructure needs, but strategic collaborations and technological advancements are expected to improve access over the next decade.

5. How might future clinical trial outcomes influence Lutathera’s market position?
Successful trials demonstrating expanded efficacy can lead to regulatory approvals, reimbursement inclusion, and increased adoption, solidifying Lutathera’s role in oncology treatment paradigms.

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References

[1] Market Research Future, "Global Neuroendocrine Tumors (NETs) Therapeutics Market," 2022.
[2] Persistence Market Research, "Radiopharmaceuticals Market Analysis and Forecast," 2023.