CLINICAL TRIALS PROFILE FOR NETSPOT

All Clinical Trials for NETSPOT

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT03325816 ↗	Nivolumab and 177Lu-DOTA0-Tyr3-Octreotate for Patients With Extensive-Stage Small Cell Lung Cancer	Completed	Bristol-Myers Squibb	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.
NCT03325816 ↗	Nivolumab and 177Lu-DOTA0-Tyr3-Octreotate for Patients With Extensive-Stage Small Cell Lung Cancer	Completed	Georgetown University	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.
NCT03325816 ↗	Nivolumab and 177Lu-DOTA0-Tyr3-Octreotate for Patients With Extensive-Stage Small Cell Lung Cancer	Completed	Giuseppe Giaccone	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 NETSPOT

Condition Name

Condition Name for NETSPOT
Intervention	Trials
Breast Cancer Stage IV	1
Carcinoid	1
Coronary Arteriosclerosis	1
Head and Neck Squamous Cell Carcinoma	1

Condition MeSH

Condition MeSH for NETSPOT
Intervention	Trials
Breast Neoplasms	1
Carcinoid Tumor	1
Myocardial Ischemia	1
Squamous Cell Carcinoma of Head and Neck	1

Clinical Trial Locations for NETSPOT

Trials by Country

Trials by Country for NETSPOT
Location	Trials
United States	5
France	1

Trials by US State

Trials by US State for NETSPOT
Location	Trials
California	1
Alabama	1
West Virginia	1
New Jersey	1
District of Columbia	1

Clinical Trial Progress for NETSPOT

Clinical Trial Phase

Clinical Trial Phase for NETSPOT
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	2
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for NETSPOT
Clinical Trial Phase	Trials
Recruiting	2
Unknown status	1
Active, not recruiting	1

Clinical Trial Sponsors for NETSPOT

Sponsor Name

Sponsor Name for NETSPOT
Sponsor	Trials
Bristol-Myers Squibb	1
Georgetown University	1
Giuseppe Giaccone	1

Sponsor Type

Sponsor Type for NETSPOT
Sponsor	Trials
Other	6
Industry	3

NETSPOT: Clinical Trials Update, Market Analysis, and Future Projections

NETSPOT, a groundbreaking diagnostic radiopharmaceutical, has revolutionized the detection of neuroendocrine tumors (NETs) since its FDA approval in 2016. This article delves into the latest clinical trials, market dynamics, and future projections for NETSPOT, offering valuable insights for healthcare professionals and industry stakeholders.

The Evolution of NETSPOT

NETSPOT, also known as gallium Ga 68 dotatate, has emerged as a game-changer in the diagnosis of somatostatin receptor-positive neuroendocrine tumors. Its journey from development to market approval has been marked by significant milestones and continuous innovation.

FDA Approval and Initial Impact

The FDA granted approval to NETSPOT on June 1, 2016, following a Priority Review[8]. This approval was based on three clinical trials involving 265 adults with known or suspected neuroendocrine tumors[7]. The rapid approval process underscored the urgent need for improved diagnostic tools in NET detection.

"NETSPOT has the potential to significantly improve the accuracy of NET diagnosis, while reducing radiation exposure for patients," stated Stefano Buono, Chief Executive Officer of Advanced Accelerator Applications[3].

Expanding Accessibility

Following its approval, Advanced Accelerator Applications (AAA) moved swiftly to expand NETSPOT's supply chain. By June 2016, AAA had partnered with two additional radiopharmacy networks, Triad Isotopes, Inc. and Nuclear Diagnostic Products, Inc., to ensure widespread availability of NETSPOT across the United States[2].

Recent Clinical Trials and Research

The landscape of NETSPOT research continues to evolve, with several ongoing clinical trials exploring its potential in various contexts.

Phase 2 Trials

Two notable Phase 2 trials are currently underway:

1. Hoag Memorial Hospital Presbyterian is conducting a study to further evaluate NETSPOT's efficacy[9].
2. RayzeBio, Inc. is exploring potential new applications or combinations involving NETSPOT[9].

Phase 3 Trial

A significant Phase 3 trial is being conducted by Assistance Publique - Hôpitaux de Paris[9]. This large-scale study aims to provide more comprehensive data on NETSPOT's performance in diverse patient populations.

Market Analysis: NETSPOT's Current Position

NETSPOT has carved out a significant niche in the neuroendocrine tumor diagnostics market since its introduction.

Market Size and Growth

The neuroendocrine tumors market, which NETSPOT serves, is projected to grow at a Compound Annual Growth Rate (CAGR) of 5.1% during the period 2020-2034[6]. This growth is driven by factors such as increasing NET incidence and advancements in diagnostic technologies.

Competitive Landscape

NETSPOT currently enjoys a strong position in the market, protected by one U.S. patent[9]. However, the landscape is dynamic, with potential for new entrants and generic versions in the future.

Future Projections and Market Dynamics

The future of NETSPOT looks promising, with several factors poised to influence its market trajectory.

Emerging Therapies and Their Impact

The anticipated launch of new therapies for neuroendocrine tumors is expected to transform the market landscape[6]. These advancements could potentially increase the demand for accurate diagnostic tools like NETSPOT.

Pediatric Applications

NETSPOT's approval for pediatric patients opens up a new market segment. The recent approval of LUTATHERA for pediatric patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs) could further drive demand for NETSPOT in this demographic[6].

Personalized Medicine Trend

The growing emphasis on personalized medicine in oncology is likely to boost the adoption of precise diagnostic tools like NETSPOT. Its ability to localize somatostatin receptor-positive tumors makes it invaluable in tailoring treatment approaches.

Clinical Impact of NETSPOT

The introduction of NETSPOT has significantly improved the diagnostic landscape for neuroendocrine tumors.

Enhanced Detection Capabilities

NETSPOT has demonstrated superior sensitivity compared to traditional diagnostic methods. It has been shown to detect 30% more lesions than Octreoscan, a previously used imaging agent[4].

Impact on Patient Management

The improved accuracy of NETSPOT has led to changes in disease management for a significant proportion of patients. Studies have shown that 71% of patients underwent a change in their treatment plan based on NETSPOT imaging results[4].

"The improved sensitivity uncovered a larger disease burden. It can have a vital role to play in the decision to alter current treatment where further lesions are identified," according to a review of patient case studies[4].

Regulatory Landscape and Future Considerations

The regulatory environment surrounding NETSPOT continues to evolve, with implications for its future market position.

Patent Protection and Generic Entry

NETSPOT is currently protected by one U.S. patent, but the potential for generic entry looms on the horizon. The exact date for possible generic versions is not publicly disclosed, but it will be a critical factor in NETSPOT's long-term market strategy[9].

Ongoing Regulatory Oversight

Health Canada's approval of NETSPOT in 2019 demonstrates the ongoing regulatory interest in this diagnostic tool[1]. Continued regulatory support and potential label expansions could further strengthen NETSPOT's market position.

Challenges and Opportunities

While NETSPOT has made significant strides, it faces both challenges and opportunities in the evolving healthcare landscape.

Radiation Exposure Considerations

One of NETSPOT's advantages is its lower radiation dose compared to alternative imaging methods. The effective dose from NETSPOT is approximately 4-8 times lower than from the administration of 111In-DTPA-octreotide[5]. This reduced radiation exposure could be a key selling point, especially for pediatric patients and those requiring multiple scans.

Expanding Indications

While NETSPOT is primarily used for neuroendocrine tumor detection, there may be opportunities to explore its efficacy in other somatostatin receptor-positive conditions. Expanding its approved indications could open up new market segments.

Integration with Emerging Technologies

As artificial intelligence and machine learning continue to advance in medical imaging, there may be opportunities to enhance NETSPOT's diagnostic capabilities through integration with these technologies.

Economic Impact and Healthcare Cost Considerations

The economic implications of NETSPOT extend beyond its market value, influencing overall healthcare costs and resource allocation.

Potential for Cost Savings

By improving diagnostic accuracy, NETSPOT has the potential to reduce the number of unnecessary procedures and treatments. The ability to detect 30% more lesions than previous methods could lead to more targeted and efficient treatment plans, potentially resulting in significant cost savings for healthcare systems[4].

Reimbursement Landscape

The reimbursement policies for NETSPOT will play a crucial role in its adoption and market penetration. Favorable reimbursement decisions by public and private payers could significantly boost its utilization.

Global Market Expansion

While much of the available data focuses on the U.S. market, NETSPOT's global potential should not be overlooked.

European Market Opportunities

With orphan drug designation from the European Medicines Agency (EMA)[8], NETSPOT has a strong foundation for expansion in the European market. The estimated combined incidence of NETs in the United States and European Union of approximately 47,300 patients per year presents a substantial market opportunity[3].

Emerging Markets

As healthcare infrastructure improves in emerging markets, there may be increasing opportunities for advanced diagnostic tools like NETSPOT. Partnerships with local healthcare providers and regulatory bodies will be crucial for successful market entry in these regions.

Future Research Directions

The future of NETSPOT will likely be shaped by ongoing research and development efforts.

Long-term Efficacy Studies

While initial studies have shown promising results, long-term follow-up studies will be crucial to fully understand NETSPOT's impact on patient outcomes and overall survival rates.

Combination Therapies

Research into how NETSPOT can be used in conjunction with emerging therapies, such as targeted molecular inhibitors, could open up new avenues for personalized treatment approaches.

Key Takeaways

1. NETSPOT has significantly improved the accuracy of neuroendocrine tumor detection, leading to changes in disease management for 71% of patients.

2. The neuroendocrine tumors market is projected to grow at a CAGR of 5.1% from 2020 to 2034, providing a favorable environment for NETSPOT's continued growth.

3. Ongoing clinical trials, including Phase 2 and Phase 3 studies, are exploring new applications and gathering more comprehensive data on NETSPOT's efficacy.

4. NETSPOT's lower radiation exposure compared to alternative imaging methods positions it favorably, especially for pediatric patients and those requiring multiple scans.

5. The potential for generic entry and emerging therapies will shape NETSPOT's future market strategy, necessitating continued innovation and market adaptation.

FAQs

1. What is NETSPOT used for? NETSPOT is a diagnostic radiopharmaceutical used for the detection of somatostatin receptor-positive neuroendocrine tumors in both adult and pediatric patients.

2. How does NETSPOT compare to traditional diagnostic methods? NETSPOT has shown superior sensitivity, detecting 30% more lesions than traditional methods like Octreoscan.

3. Are there any side effects associated with NETSPOT? While generally well-tolerated, some reported adverse reactions include nausea, vomiting, and injection site reactions. These are typically mild to moderate and transient.

4. How often do patients need to undergo NETSPOT imaging? The frequency of NETSPOT imaging depends on individual patient circumstances and is determined by the treating physician based on factors such as disease progression and treatment response.

5. Is NETSPOT covered by insurance? Coverage varies by insurance provider and plan. It's best to check with your specific insurance company for details on coverage and potential out-of-pocket costs.

Sources cited: [1] https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00467 [2] https://www.biospace.com/advanced-accelerator-applications-expands-u-s-netspot-supply-chain-with-two-additional-radiopharmacy-networks [3] https://www.biospace.com/advanced-accelerator-applications-applications-announces-fda-approval-of-netspot-somakit-tate-a-kit-for-the-preparation-of-gallium-ga-68-dotatate [4] https://www.dmshealth.com/09/the-clinical-impact-of-utilizing-netspot/ [5] https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00532 [6] https://www.globenewswire.com/news-release/2024/11/25/2986962/0/en/Neuroendocrine-Tumors-Market-to-Showcase-Rapid-Growth-During-the-Study-Period-2020-2034-at-a-CAGR-of-5-1-DelveInsight.html [7] https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-netspot [8] https://journals.lww.com/oncology-times/fulltext/2016/07250/fda_approves_netspot_to_detect_rare_neuroendocrine.23.aspx [9] https://www.drugpatentwatch.com/p/tradename/NETSPOT

Last updated: 2025-01-22