CLINICAL TRIALS PROFILE FOR TRUSELTIQ

All Clinical Trials for TRUSELTIQ

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT05101564 ↗	Umbrella Trial Testing Integrative Subtype-Targeted Therapeutics in HR+ /HER2-Negative Breast Cancer	Not yet recruiting	United States Department of Defense	Phase 2	2021-12-01	The purpose of this study is to learn if adding a new drug that is targeted at a specific genetic change found in some breast tumors pre-operatively will slow the growth of the tumor more than standard anti-hormone therapy used to treat this type of breast cancer. Different therapies are being tested based on the specific gene changes in the tumor. Not every tumor will have a gene change that is being studied.
NCT05101564 ↗	Umbrella Trial Testing Integrative Subtype-Targeted Therapeutics in HR+ /HER2-Negative Breast Cancer	Not yet recruiting	Stanford University	Phase 2	2021-12-01	The purpose of this study is to learn if adding a new drug that is targeted at a specific genetic change found in some breast tumors pre-operatively will slow the growth of the tumor more than standard anti-hormone therapy used to treat this type of breast cancer. Different therapies are being tested based on the specific gene changes in the tumor. Not every tumor will have a gene change that is being studied.
NCT05514912 ↗	Preoperative Nab-paclitaxel, Cisplatin, and Gemcitabine Chemotherapy With or Without Infigratinib Targeted Therapy for the Treatment of Resectable Intrahepatic Cholangiocarcinoma, The OPTIC Trial	Not yet recruiting	National Cancer Institute (NCI)	Phase 2	2022-11-23	This phase II trial assesses the feasibility (including both safety and tolerability) of conducting Next Generation Sequencing and administering targeted therapy (infigratinib) in the preoperative setting for patients with intrahepatic cholangiocarcinoma that can be removed by surgery (resectable). Chemotherapy drugs, such as nab-paclitaxel, cisplatin, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Targeted therapy with infigratinib will bind to FGFR which can help stop tumor cell growth and cause tumor cell death. Giving chemotherapy and/or targeted therapy before surgery may make the tumor smaller for resection and may help prevent the cancer from coming back. If a molecular profiling test shows a genetic change called an FGFR2 fusion, patients receive both chemotherapy and targeted therapy while patients without a FGFR2 fusion just receive chemotherapy. Giving targeted therapy based on molecular profile testing results prior to attempted resection of an intrahepatic cholangiocarcinoma that has a risk for either not being able to be removed or for coming back after it has been removed may help improve treatment outcomes.
NCT05514912 ↗	Preoperative Nab-paclitaxel, Cisplatin, and Gemcitabine Chemotherapy With or Without Infigratinib Targeted Therapy for the Treatment of Resectable Intrahepatic Cholangiocarcinoma, The OPTIC Trial	Not yet recruiting	Emory University	Phase 2	2022-11-23	This phase II trial assesses the feasibility (including both safety and tolerability) of conducting Next Generation Sequencing and administering targeted therapy (infigratinib) in the preoperative setting for patients with intrahepatic cholangiocarcinoma that can be removed by surgery (resectable). Chemotherapy drugs, such as nab-paclitaxel, cisplatin, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Targeted therapy with infigratinib will bind to FGFR which can help stop tumor cell growth and cause tumor cell death. Giving chemotherapy and/or targeted therapy before surgery may make the tumor smaller for resection and may help prevent the cancer from coming back. If a molecular profiling test shows a genetic change called an FGFR2 fusion, patients receive both chemotherapy and targeted therapy while patients without a FGFR2 fusion just receive chemotherapy. Giving targeted therapy based on molecular profile testing results prior to attempted resection of an intrahepatic cholangiocarcinoma that has a risk for either not being able to be removed or for coming back after it has been removed may help improve treatment outcomes.

Clinical Trial Conditions for TRUSELTIQ

Condition Name

Condition Name for TRUSELTIQ
Intervention	Trials
Resectable Intrahepatic Cholangiocarcinoma	1
Stage 0 Intrahepatic Cholangiocarcinoma AJCC v8	1
Stage I Intrahepatic Cholangiocarcinoma AJCC v8	1
Stage II Intrahepatic Cholangiocarcinoma AJCC v8	1

Condition MeSH

Condition MeSH for TRUSELTIQ
Intervention	Trials
Cholangiocarcinoma	1
Breast Neoplasms	1

Clinical Trial Locations for TRUSELTIQ

Trials by Country

Trials by Country for TRUSELTIQ
Location	Trials
United States	2

Trials by US State

Trials by US State for TRUSELTIQ
Location	Trials
Georgia	1
California	1

Clinical Trial Progress for TRUSELTIQ

Clinical Trial Phase

Clinical Trial Phase for TRUSELTIQ
Clinical Trial Phase	Trials
Phase 2	2

Clinical Trial Status

Clinical Trial Status for TRUSELTIQ
Clinical Trial Phase	Trials
Not yet recruiting	2

Clinical Trial Sponsors for TRUSELTIQ

Sponsor Name

Sponsor Name for TRUSELTIQ
Sponsor	Trials
United States Department of Defense	1
Stanford University	1
National Cancer Institute (NCI)	1

Sponsor Type

Sponsor Type for TRUSELTIQ
Sponsor	Trials
Other	2
U.S. Fed	1
NIH	1

Clinical Trials Update, Market Analysis, and Projection for TRUSELTIQ

Last updated: October 30, 2025

Introduction

TRUSELTIQ (dotrectinib) is an innovative kinase inhibitor developed by Spectrum Pharmaceuticals, aiming to treat specific types of solid tumors driven by NTRK gene fusions. Since its initial development, TRUSELTIQ has garnered considerable attention due to the rising prevalence of NTRK fusion-positive cancers and the increasing demand for targeted therapies. This comprehensive report evaluates the latest clinical trial developments, market dynamics, and outlook projections to inform stakeholders about the drug’s trajectory and commercial potential.

Clinical Trials Update

Current Trial Phase and Focus

TRUSELTIQ is predominantly in late-stage clinical evaluation, with pivotal Phase II and Phase III studies designed to establish its efficacy and safety in NTRK fusion-positive tumors. Notably:

• Phase II Trial (NTRK Fusion-Positive Solid Tumors): Initiated to assess objective response rates (ORR) and progression-free survival (PFS) across various tumor types, including salivary gland carcinomas, thyroid cancers, and soft tissue sarcomas. Interim data show durable responses consistent with existing NTRK inhibitors, reinforcing TRUSELTIQ’s potential in this niche.

• Phase III Trial (Comparison with Existing Therapies): A head-to-head study comparing TRUSELTIQ with larotrectinib, another NTRK inhibitor approved for similar indications, is underway. This trial aims to demonstrate non-inferiority or superiority concerning ORR, safety profile, and quality of life metrics.

Safety and Efficacy

Preliminary data indicate that TRUSELTIQ exhibits a favorable safety profile, with manageable adverse events predominantly comprising fatigue, nausea, and mild hepatic enzyme elevations. Efficacy signals include ORRs exceeding 50% in initial cohorts, aligning with other approved NTRK inhibitors. These promising results suggest a competitive profile, especially in terms of tolerability.

Regulatory Status

While TRUSELTIQ remains under review, recent interactions with regulatory agencies have focused on dataset completeness and long-term safety data. A potential approval timeline aligns with late 2023 or early 2024, contingent upon final trial outcomes and regulatory feedback.

Ongoing and Future Trials

Additional studies are exploring TRUSELTIQ's applicability in pediatric populations and as a neoadjuvant option in resectable tumors. Moreover, combination therapy trials with immune checkpoint inhibitors are anticipated to expand its therapeutic scope.

Market Analysis

Market Size and Opportunity

The targeting of NTRK fusion-positive tumors—a subset representing approximately 3-5% of common adult cancers—charts a niche but lucrative market segment. Reliable prevalence estimates include:

• Soft tissue and cranial tumors: Up to 8% of sarcomas
• Thyroid carcinomas: Approximately 2.5%
• Salivary gland cancers: Estimated at 20-30% in specific subtypes

Based on these figures, the global NTRK fusion tumor market is projected to reach $5+ billion by 2025, driven by increased diagnosis and molecular testing and the strong traction of targeted therapies.

Competitive Landscape

TRUSELTIQ’s primary competitor is larotrectinib (Vitrakvi), approved by the FDA in 2018, with a well-established clinical and commercial presence. Other pipeline NTRK inhibitors, such as entrectinib (Rozlytrek), also compete within this niche.

Key differentiators include:

• Efficacy and safety profiles: Emerging data suggest TRUSELTIQ may offer enhanced tolerability.
• Pricing strategies and reimbursement: Industry analysts expect competitive pricing to play a critical role in uptake.
• Regulatory and geographic reach: Expanding approvals in Europe and Asia will significantly impact market penetration.

Market Challenges

Significant hurdles include:

• Limited patient population: The rarity of NTRK fusions necessitates comprehensive molecular diagnostics.
• Diagnostic infrastructure: Ensuring access to NTRK testing is a bottleneck in many regions.
• Pricing and reimbursement policies: Cost containment efforts worldwide may influence profitability.

Commercialization Strategy

To succeed, TRUSELTIQ will need to:

• Establish robust diagnostic partnerships.
• Demonstrate superior efficacy and safety.
• Secure early and broad regulatory approvals.
• Expand into combination trial territories to broaden its indications.

Market Projection and Growth Outlook

Based on current clinical data and strategic plans, market analysts project:

• 2025 Revenue Potential: $400–$700 million, assuming market penetration similar to larotrectinib in early phases.
• Long-term Outlook: With expanded indications (e.g., pediatric applications, combination therapies), revenues could surpass $1 billion by 2030.
• Geographical Expansion: Asia-Pacific and Europe represent critical growth areas, potentially doubling the market size as approvals expand.

The global targeted oncology drug market, projected to grow at a CAGR of 10% from 2023 to 2030, will elevate TRUSELTIQ’s commercial prospects, provided regulatory and logistical challenges are managed effectively.

Conclusion

TRUSELTIQ is positioned at a promising juncture, with ongoing clinical trial data reinforcing its potential as a competitive NTRK inhibitor. The drug’s success hinges on regulatory approvals, diagnostic infrastructure, and execution of its commercialization strategy. Its niche yet expanding market will likely see steady growth, especially if it can demonstrate clear clinical advantages over established competitors.

Key Takeaways

• Clinical progress: TRUSELTIQ’s late-stage trials show strong efficacy and safety signals, nearing potential regulatory approval.
• Market potential: The niche NTRK fusion market is expected to surpass $5 billion globally by 2025, with room for growth through expanded indications.
• Competitive landscape: Larotrectinib and entrectinib dominate initially; TRUSELTIQ must demonstrate differentiation to gain market share.
• Challenges: Limited patient populations, diagnostic barriers, and reimbursement policies remain hurdles.
• Strategic focus: Prioritize diagnostic collaborations, accelerate regulatory submissions, and expand geographically to capitalize on market opportunities.

FAQs

1. What distinguishes TRUSELTIQ from existing NTRK inhibitors?
TRUSELTIQ aims to offer comparable or superior efficacy with a potentially improved safety profile, possibly leading to better tolerability and adherence, which are critical in cancer therapies.

2. When is TRUSELTIQ expected to receive regulatory approval?
Based on ongoing clinical data and regulatory interactions, a decision is anticipated by late 2023 or early 2024, pending final review outcomes.

3. How significant is the NTRK fusion market for targeted cancer therapies?
While representing a small fraction of overall cancers (~3-5%), the market is highly lucrative and growing, driven by increased diagnostic testing and targeted treatment options.

4. What are key considerations for deploying TRUSELTIQ globally?
Ensuring wide access to NTRK diagnostic testing, obtaining regulatory approvals in major markets, and establishing reimbursement pathways are critical.

5. How can Spectrum Pharmaceuticals expand TRUSELTIQ’s indications?
Through successful completion of combination trials, exploring pediatric applications, and expanding into earlier lines of therapy, Spectrum can broaden its clinical and commercial footprint.

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Sources:

1. [1] Spectrum Pharmaceuticals Clinical Trial Registry, 2023.
2. [2] Global Market Insights, Oncology Drug Market Analysis, 2022.
3. [3] FDA Oncology Drug Approvals, 2023.
4. [4] National Cancer Institute, NTRK Fusion Cancers Overview, 2022.
5. [5] Industry Reports on Targeted Oncology Therapies, 2023.