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	5
Metastatic Pancreatic Neuroendocrine Tumor	2
Grade I Meningioma	1
Midgut Neuroendocrine Tumours	1

Condition MeSH

Condition MeSH for Lutetium Lu 177 Dotatate
Intervention	Trials
Neuroendocrine Tumors	13
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	30
Australia	4
Netherlands	1
Canada	1

Trials by US State

Trials by US State for Lutetium Lu 177 Dotatate
Location	Trials
Massachusetts	3
Kentucky	3
California	3
Texas	3
Pennsylvania	2

Clinical Trial Progress for Lutetium Lu 177 Dotatate

Clinical Trial Phase

Clinical Trial Phase for Lutetium Lu 177 Dotatate
Clinical Trial Phase	Trials
Phase 2/Phase 3	1
Phase 2	11
Phase 1/Phase 2	3

Clinical Trial Status

Clinical Trial Status for Lutetium Lu 177 Dotatate
Clinical Trial Phase	Trials
Not yet recruiting	9
Recruiting	8
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)	11
Pashtoon M. Kasi	1
University Health Network, Toronto	1

Sponsor Type

Sponsor Type for Lutetium Lu 177 Dotatate
Sponsor	Trials
Other	16
NIH	12
Industry	8

Lutetium Lu 177 Dotatate: Clinical Trials, Market Analysis, and Projections

Introduction

Lutetium Lu 177 dotatate, commonly known by the brand name Lutathera, is a radiolabeled somatostatin analog that has revolutionized the treatment of certain types of cancer, particularly neuroendocrine tumors (NETs) and prostate cancer. This article delves into the current clinical trials, market analysis, and future projections for this groundbreaking drug.

Clinical Trials and Efficacy

Ongoing and Completed Trials

One of the significant clinical trials involving lutetium Lu 177 dotatate is the phase II trial comparing its efficacy to everolimus in treating patients with somatostatin receptor-positive bronchial neuroendocrine tumors. In this trial, patients receive lutetium Lu 177 dotatate intravenously every 56 days for four cycles, with regular PET, CT, or MRI scans to monitor the treatment's effectiveness[1].

The NETTER-1 trial, a randomized, controlled phase III study, demonstrated the efficacy and safety of lutetium Lu 177 dotatate in patients with advanced, progressive, somatostatin-receptor-positive midgut neuroendocrine tumors. The trial showed significant improvements in progression-free survival and symptom management for these patients[4].

Pediatric Indications

Recently, the FDA approved lutetium Lu 177 dotatate for pediatric patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This approval was based on pharmacokinetic, dosimetry, and safety data from the NETTER-P study, as well as the extrapolation of efficacy outcomes from the NETTER-1 trial in adult patients[5].

Generic Versions and Collaborations

The FDA has accepted the filing of an abbreviated new drug application (ANDA) for a generic version of lutetium Lu 177 dotatate, which could potentially increase accessibility and reduce costs for patients. This development is part of a collaboration between Lantheus and POINT Biopharma, highlighting the growing interest in radiopharmaceuticals and the potential for expanded therapeutic options[3].

Market Analysis

Current Market Size and Growth

The lutetium-177 market has seen significant growth, with the market size estimated at USD 167.7 million in 2023 and projected to reach USD 653.53 million by 2030, growing at a compound annual growth rate (CAGR) of 21.44%[2].

Market Drivers

Several factors are driving the growth of the lutetium-177 market:

• Increasing Adoption of Targeted Radionuclide Therapy: The efficacy of lutetium-177 in treating various cancers, particularly NETs and prostate cancer, has led to increased adoption in clinical practice.
• Rising Prevalence of Neuroendocrine Tumors: The need for advanced therapies for NETs is driving the demand for lutetium-177-based treatments.
• Government Funding and Support: Government initiatives and funding for nuclear medicine research are also contributing to the market's expansion[2].

Market Restraints

Despite the promising growth, there are several challenges:

• Complex Production and Supply Chain Logistics: The production of high-purity lutetium-177 is complex and costly, which can limit its availability.
• Stringent Regulatory Requirements: Regulatory barriers and compliance issues can hinder the widespread use of lutetium-177[2].

Market Opportunities

The future of lutetium-177 looks promising with several opportunities:

• Expanding Treatment Indications: Research is exploring the use of lutetium-177 for non-cancer applications, such as inflammatory diseases and benign tumors.
• Innovations in Radiopharmaceuticals and Imaging Technologies: Advances in these areas are expected to enhance the therapeutic use and efficacy of lutetium-177.
• Collaborative Research and Emerging Markets: Collaborations between companies and penetration into emerging markets are likely to drive further growth[2].

Applications and Therapeutic Uses

Targeted Radionuclide Therapy

Lutetium-177 delivers beta radiation directly to cancer cells, minimizing damage to healthy tissues. This targeted approach is particularly effective in treating:

• Neuroendocrine Tumors (NETs): Lutetium-177-DOTATATE (Lutathera) targets somatostatin receptors overexpressed in NETs, reducing tumor size and improving patient outcomes.
• Prostate Cancer: Lutetium-177-PSMA therapies target prostate-specific membrane antigen (PSMA), a protein overexpressed in prostate cancer cells, showing promise in treating metastatic castration-resistant prostate cancer (mCRPC)[2].

Clinical Evidence

Clinical trials have provided significant evidence of the efficacy of lutetium-177:

• NETs: The NETTER-1 trial demonstrated improvements in progression-free survival and symptom management for advanced, metastatic, or inoperable NETs.
• Prostate Cancer: Lutetium-177-PSMA therapies have shown advances in tumor reduction, disease stabilization, and increased survival times[2].

Future Potential

Non-Cancer Applications

Research is exploring the use of lutetium-177-based radiopharmaceuticals for:

• Inflammatory Diseases: Targeting abnormal tissue growth selectively could expand the therapeutic use of lutetium-177 beyond oncology.
• Benign Tumors and Endocrine Conditions: The potential to treat benign tumors and endocrine conditions with lutetium-177 is being investigated[2].

Enhancing Production Efficiency

Efforts to enhance production efficiency and reduce costs are underway. This includes developing new lutetium-177 compounds and improving supply chain logistics, which could make the treatment more accessible and affordable[2].

Key Takeaways

• Clinical Trials: Ongoing and completed trials have demonstrated the efficacy of lutetium Lu 177 dotatate in treating NETs and prostate cancer.
• Market Growth: The market is projected to grow significantly, driven by increasing adoption of targeted radionuclide therapy and rising prevalence of NETs.
• Therapeutic Uses: Lutetium-177 is effective in treating NETs and prostate cancer, with potential applications in non-cancer conditions.
• Future Potential: Innovations in radiopharmaceuticals, imaging technologies, and collaborative research are expected to drive further growth.

FAQs

What is lutetium Lu 177 dotatate used for?

Lutetium Lu 177 dotatate is used primarily for the treatment of neuroendocrine tumors (NETs) and prostate cancer, targeting somatostatin receptors and prostate-specific membrane antigen (PSMA) respectively.

What are the benefits of lutetium Lu 177 dotatate over traditional treatments?

Lutetium Lu 177 dotatate offers targeted therapy, delivering radiation directly to cancer cells while minimizing harm to healthy tissues, which can lead to better patient outcomes and reduced side effects.

What are the current market trends for lutetium-177?

The market is growing at a CAGR of 21.44%, driven by increasing adoption of targeted radionuclide therapy, rising prevalence of NETs, and government funding for nuclear medicine research.

What are the challenges in the production and supply of lutetium-177?

The production of high-purity lutetium-177 is complex and costly, and there are stringent regulatory requirements and limited supply chain logistics that can hinder its availability.

Is lutetium Lu 177 dotatate approved for pediatric use?

Yes, the FDA has approved lutetium Lu 177 dotatate for pediatric patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs)[5].

References

1. ClinicalTrials.gov: Testing Lutetium Lu 177 Dotatate in Patients With Somatostatin Receptor Positive Bronchial Neuroendocrine Tumors.
2. GlobeNewswire: Lutetium-177 Industry Research Report 2024: Carrier Added Lutetium-177, Non-Carrier-Added Lutetium-177, Global Forecast 2024-2030.
3. Onclive: FDA Accepts Filing of Abbreviated NDA for Generic Lutathera in GEP-NETs.
4. Aetna: Lutetium Lu 177 Dotatate (Lutathera) and Lutetium Lu 177 Octreotate.
5. FDA: FDA Approves Lutetium Lu 177 Dotatate for Pediatric Patients 12 Years and Older with GEP-NETs.