CLINICAL TRIALS PROFILE FOR NEOSAR

505(b)(2) Clinical Trials for NEOSAR

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT03742258 ↗	Combination Chemotherapy and TAK-659 as Front-Line Treatment in Treating Patients With High-Risk Diffuse Large B Cell Lymphoma	Active, not recruiting	National Cancer Institute (NCI)	Phase 1	2019-03-13	The purpose of this research study is to evaluate a new investigational drug, TAK-659, given in combination with standard chemotherapy, for the treatment of Diffuse Large B-cell Lymphoma (DLBCL). ?Investigational? means that TAK-659 has not been approved by the United States Food and Drug Administration (FDA) for use as a prescription or over-the-counter medication to treat a certain condition. The primary purpose of this study is to find the appropriate and safe dose of the study drug to be used in combination with standard chemotherapy for the treatment of your disease and to determine how well the drug works in treating the disease. Other objectives include measuring the amount of the study drug in the body at different times after taking the study drug. Participation in the study is expected to last for up to 3 years after receiving the last dose of the study drug. Patients will receive the study treatment for up to 18 weeks, as long as they are benefitting.
OTC	NCT03742258 ↗	Combination Chemotherapy and TAK-659 as Front-Line Treatment in Treating Patients With High-Risk Diffuse Large B Cell Lymphoma	Active, not recruiting	Northwestern University	Phase 1	2019-03-13	The purpose of this research study is to evaluate a new investigational drug, TAK-659, given in combination with standard chemotherapy, for the treatment of Diffuse Large B-cell Lymphoma (DLBCL). ?Investigational? means that TAK-659 has not been approved by the United States Food and Drug Administration (FDA) for use as a prescription or over-the-counter medication to treat a certain condition. The primary purpose of this study is to find the appropriate and safe dose of the study drug to be used in combination with standard chemotherapy for the treatment of your disease and to determine how well the drug works in treating the disease. Other objectives include measuring the amount of the study drug in the body at different times after taking the study drug. Participation in the study is expected to last for up to 3 years after receiving the last dose of the study drug. Patients will receive the study treatment for up to 18 weeks, as long as they are benefitting.
New Dosage	NCT01760226 ↗	Dose Adjusted EPOCH-R, to Treat Mature B Cell Malignancies	Completed	National Cancer Institute (NCI)	Early Phase 1	2013-01-01	The subject is invited to take part in this research study because s/he has been diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL), Primary Mediastinal B-cell Lymphoma (PMBCL), or Post-transplant Lymphoproliferative Disorder (PTLD). In an attempt to improve cure rates while reducing harmful effects from drugs, oncologists are developing new treatment protocols. One such protocol, entitled dose-adjusted EPOCH-R, utilizes two major new strategies. First, the treatment approach utilizes continuous infusion of chemotherapy over four days, instead of being administered over minutes or hours. Secondly, the doses of some medications involved are increased or decreased based on how the drugs affect the subject's ability to produce blood cells, which is used as a measure of how rapidly the body is processing drugs. Using this approach in adults, researchers have shown improved cure rates in these cancers. Additionally, the harmful effects experienced by patients has been mild, with mucositis, severe infections, and tumor lysis syndrome occurring rarely. However, this new dosing method has never been used in children, and the effectiveness and side effects of this new method are unknown in children. The purpose of this study is to look at the safety of dose-adjusted EPOCH-R in the treatment of children with mature B-cell cancers, and to see if we can maintain cure rates (as has been shown in adults). This study represents the first trial of dose-adjusted EPOCH-R in children.
New Dosage	NCT01760226 ↗	Dose Adjusted EPOCH-R, to Treat Mature B Cell Malignancies	Completed	Texas Children's Hospital	Early Phase 1	2013-01-01	The subject is invited to take part in this research study because s/he has been diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL), Primary Mediastinal B-cell Lymphoma (PMBCL), or Post-transplant Lymphoproliferative Disorder (PTLD). In an attempt to improve cure rates while reducing harmful effects from drugs, oncologists are developing new treatment protocols. One such protocol, entitled dose-adjusted EPOCH-R, utilizes two major new strategies. First, the treatment approach utilizes continuous infusion of chemotherapy over four days, instead of being administered over minutes or hours. Secondly, the doses of some medications involved are increased or decreased based on how the drugs affect the subject's ability to produce blood cells, which is used as a measure of how rapidly the body is processing drugs. Using this approach in adults, researchers have shown improved cure rates in these cancers. Additionally, the harmful effects experienced by patients has been mild, with mucositis, severe infections, and tumor lysis syndrome occurring rarely. However, this new dosing method has never been used in children, and the effectiveness and side effects of this new method are unknown in children. The purpose of this study is to look at the safety of dose-adjusted EPOCH-R in the treatment of children with mature B-cell cancers, and to see if we can maintain cure rates (as has been shown in adults). This study represents the first trial of dose-adjusted EPOCH-R in children.
New Dosage	NCT01760226 ↗	Dose Adjusted EPOCH-R, to Treat Mature B Cell Malignancies	Completed	Baylor College of Medicine	Early Phase 1	2013-01-01	The subject is invited to take part in this research study because s/he has been diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL), Primary Mediastinal B-cell Lymphoma (PMBCL), or Post-transplant Lymphoproliferative Disorder (PTLD). In an attempt to improve cure rates while reducing harmful effects from drugs, oncologists are developing new treatment protocols. One such protocol, entitled dose-adjusted EPOCH-R, utilizes two major new strategies. First, the treatment approach utilizes continuous infusion of chemotherapy over four days, instead of being administered over minutes or hours. Secondly, the doses of some medications involved are increased or decreased based on how the drugs affect the subject's ability to produce blood cells, which is used as a measure of how rapidly the body is processing drugs. Using this approach in adults, researchers have shown improved cure rates in these cancers. Additionally, the harmful effects experienced by patients has been mild, with mucositis, severe infections, and tumor lysis syndrome occurring rarely. However, this new dosing method has never been used in children, and the effectiveness and side effects of this new method are unknown in children. The purpose of this study is to look at the safety of dose-adjusted EPOCH-R in the treatment of children with mature B-cell cancers, and to see if we can maintain cure rates (as has been shown in adults). This study represents the first trial of dose-adjusted EPOCH-R in children.

All Clinical Trials for NEOSAR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002835 ↗	Combination Chemotherapy in Treating Patients With Lymphoma	Completed	National Cancer Institute (NCI)	Phase 3	1995-10-30	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of combination chemotherapy in treating patients who have intermediate-grade or immunoblastic lymphoma.
NCT00002831 ↗	Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous or Acute Leukemia	Completed	National Cancer Institute (NCI)	Phase 1/Phase 2	1995-08-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of high-dose chemotherapy plus peripheral stem cell transplantation in treating patients with chronic myelogenous or acute leukemia.
NCT00002831 ↗	Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous or Acute Leukemia	Completed	M.D. Anderson Cancer Center	Phase 1/Phase 2	1995-08-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of high-dose chemotherapy plus peripheral stem cell transplantation in treating patients with chronic myelogenous or acute leukemia.
NCT00002829 ↗	Bone Marrow Transplantation in Treating Patients With Lymphoma	Completed	National Cancer Institute (NCI)	Phase 2	1994-02-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells, and may be an effective treatment for lymphoma. Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill cancer cells. PURPOSE: Phase II trial to study the effectiveness of bone marrow transplantation in treating patients with recurrent or residual low-grade lymphoma.
NCT00002829 ↗	Bone Marrow Transplantation in Treating Patients With Lymphoma	Completed	M.D. Anderson Cancer Center	Phase 2	1994-02-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells, and may be an effective treatment for lymphoma. Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill cancer cells. PURPOSE: Phase II trial to study the effectiveness of bone marrow transplantation in treating patients with recurrent or residual low-grade lymphoma.
NCT00002524 ↗	Combination Chemotherapy in Treating Patients With AIDS-Related Lymphoma	Completed	National Cancer Institute (NCI)	Phase 2	1993-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with AIDS-related lymphoma.
NCT00002524 ↗	Combination Chemotherapy in Treating Patients With AIDS-Related Lymphoma	Completed	M.D. Anderson Cancer Center	Phase 2	1993-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with AIDS-related lymphoma.

Clinical Trial Conditions for NEOSAR

Condition Name

Condition Name for NEOSAR
Intervention	Trials
Acute Lymphoblastic Leukemia	47
Leukemia	45
Lymphoma	40
Myelodysplastic Syndrome	24

Condition MeSH

Condition MeSH for NEOSAR
Intervention	Trials
Leukemia	147
Lymphoma	147
Leukemia, Lymphoid	114
Precursor Cell Lymphoblastic Leukemia-Lymphoma	94

Clinical Trial Locations for NEOSAR

Trials by Country

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−

Trials by Country for NEOSAR
Location	Trials
New Zealand	44
Switzerland	9
Ireland	9
Brazil	9
Italy	8

Trials by US State

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−

Trials by US State for NEOSAR
Location	Trials
Texas	196
California	134
Washington	105
New York	96
Pennsylvania	91

Clinical Trial Progress for NEOSAR

Clinical Trial Phase

Clinical Trial Phase for NEOSAR
Clinical Trial Phase	Trials
Phase 3	61
Phase 2/Phase 3	3
Phase 2	172

Clinical Trial Status

Clinical Trial Status for NEOSAR
Clinical Trial Phase	Trials
Recruiting	118
Completed	114
Active, not recruiting	85

Clinical Trial Sponsors for NEOSAR

Sponsor Name

Sponsor Name for NEOSAR
Sponsor	Trials
National Cancer Institute (NCI)	268
M.D. Anderson Cancer Center	122
Fred Hutchinson Cancer Research Center	33

Sponsor Type

Sponsor Type for NEOSAR
Sponsor	Trials
Other	436
NIH	287
Industry	142

Clinical Trials, Market Analysis, and Projections for NSCLC Drugs: A Focus on Emerging Therapies

Introduction to NSCLC and Clinical Trials

Non-Small Cell Lung Cancer (NSCLC) is one of the most common types of lung cancer, accounting for about 85% of all lung cancer cases. The treatment landscape for NSCLC is rapidly evolving, driven by advancements in clinical trials and the development of new therapies.

Current State of NSCLC Clinical Trials

Clinical trials play a crucial role in the development of new treatments for NSCLC. Here are some key points regarding current clinical trials:

• Increasing Number of Trials: The number of registered clinical trials has been growing significantly to meet the increasing demand for treatments for chronic diseases, including NSCLC. This trend is expected to continue, with a significant portion of these trials being conducted outside of the U.S. and the European Union due to cost-effectiveness and easier regulatory processes[3][5].

• Diverse Therapeutic Approaches: Clinical trials are exploring various therapeutic approaches, including targeted therapies, immunotherapies, and combination therapies. For instance, AstraZeneca's Imfinzi (durvalumab) is being tested in several trials, including those for resectable NSCLC and in combination with chemotherapy and radiation therapy[1].

• Repurposing Non-Cancer Drugs: There is also a growing interest in repurposing non-cancer drugs as potential cancer treatments. The ReDO_Trials_DB database lists over 900 active clinical trials investigating the use of such drugs, with medications like metformin and celecoxib being among the most popular[4].

Market Analysis for NSCLC Drugs

The NSCLC market is projected to experience significant growth over the next few years.

• Global Market Size: By 2025, the global NSCLC market is expected to reach $26.8 billion in the 8 major markets (8MM), growing at a Compound Annual Growth Rate (CAGR) of 15.7%[2].

• Regional Growth: The China NSCLC market is anticipated to grow the most rapidly, increasing to $4.3 billion by 2025 at a CAGR of 25.4%. The U.S. and Japan will see their market shares decrease, while the 5EU will increase its share to 34.3% by 2025[2].

• Major Drivers of Growth: Targeted therapies, such as AstraZeneca’s Tagrisso (osimertinib) and Roche’s Avastin (bevacizumab), are expected to drive market growth. Tagrisso, in particular, is projected to achieve blockbuster status with estimated sales of $1.7 billion by 2025, driven by its uptake in the second-line and first-line settings for EGFR-mutant patients[2].

Emerging Therapies in NSCLC

Several emerging therapies are being developed and tested in clinical trials for NSCLC.

• Immunotherapies: Immunotherapies, including checkpoint inhibitors like PD-1 and CTLA-4 inhibitors, are gaining traction. For example, volrustomig (PD-1/CTLA-4) and rilvegostomig (PD-1/TIGIT) are bispecific monoclonal antibodies being developed by AstraZeneca[1].

• Targeted Therapies: New targeted therapies are also on the horizon. AZD5335, an anti-FRα TOP1i ADC, is being tested for ovarian cancer and lung adenocarcinoma. Similarly, AZD9574, a PARP inhibitor, is being investigated for advanced solid malignancies[1].

• Combination Therapies: Combination therapies are another area of focus. Trials like the NeoADAURA trial for Tagrisso in resectable NSCLC and the MATTERHORN trial for Imfinzi in resectable gastric and gastroesophageal junction cancer are exploring the efficacy of combining different therapeutic approaches[1].

Market Projections and Trends

• Growth in Incidence: The increasing incidence of NSCLC, particularly in urban China, will drive market growth. The incidence of NSCLC is expected to increase at an Annual Growth Rate (AGR) of 3.1% from 2015 to 2025 across the 8MM[2].

• Shift to Immunotherapies: By 2025, immunotherapies are expected to dominate the NSCLC market, accounting for 65% of total sales, while chemotherapy and targeted agents will account for the remaining 35%[2].

• Biosimilar Impact: The introduction of biosimilars, such as biosimilar bevacizumab, will impact the market. Biosimilar bevacizumab is expected to achieve $1 billion in sales by 2025, assuming a 30% discount compared to branded Avastin[2].

Challenges and Opportunities

• Cost of Clinical Trials: One of the major challenges facing the clinical trials market is the rising cost of conducting trials. This poses a significant barrier to the development of new therapies[5].

• Technological Advancements: The integration of AI and other advanced technologies in clinical trials is expected to redefine market trends and improve efficiency. However, this also brings new challenges related to data management and regulatory compliance[5].

Key Takeaways

• The NSCLC market is projected to grow significantly, driven by targeted therapies and immunotherapies.
• Emerging therapies, including bispecific monoclonal antibodies and new targeted therapies, are being developed and tested in clinical trials.
• The increasing incidence of NSCLC, particularly in China, will drive market growth.
• Immunotherapies are expected to dominate the market by 2025.
• The cost of clinical trials and the impact of biosimilars are key factors to consider in market projections.

FAQs

Q: What is the projected global market size for NSCLC drugs by 2025? A: The global NSCLC market is expected to reach $26.8 billion by 2025[2].

Q: Which region is expected to see the most rapid growth in the NSCLC market? A: China is anticipated to see the most rapid growth, with a CAGR of 25.4% by 2025[2].

Q: What are the major drivers of growth in the NSCLC market? A: Targeted therapies, such as Tagrisso and Avastin, and the increasing incidence of NSCLC are major drivers of growth[2].

Q: How are immunotherapies expected to impact the NSCLC market by 2025? A: Immunotherapies are expected to account for 65% of the total NSCLC market by 2025[2].

Q: What challenges do clinical trials for NSCLC drugs face? A: One of the major challenges is the rising cost of conducting clinical trials[5].

Sources

1. AstraZeneca - H1-and-Q2-2023-results-clinical-trials-appendix.pdf
2. GlobalData - NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025
3. Fortune Business Insights - Clinical Trials Market Size, Share, Industry Trends, Growth, 2032
4. Anticancer Fund - Database repurposing trials in oncology
5. Technavio via PR Newswire - Clinical Trials Market in the US to grow by USD 5 Billion from 2024-2028