CLINICAL TRIALS PROFILE FOR PLUVICTO

All Clinical Trials for PLUVICTO

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT05682443 ↗	Phase 2 Study of ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC	Not yet recruiting	Prostate Cancer Clinical Trials Consortium	Phase 2	2023-05-01	The goal of this clinical trial is to examine the safety and efficacy of ONC-392 in combination with lutetium Lu 177 vipivotide tetraxetan in metastatic castration resistant prostate cancer patient who have disease progressed on androgen receptor pathway inhibition. The main questions it aims to answer are (1) whether it is safe to combine ONC-392 with lutetium Lu 177 vipivotide tetraxetan, (2) whether the combination increases the radiographic progression free survival (rPFS). Participants will be randomized to two arms in 2:1 ratio. In experimental arm, they will be given ONC-392 10 mg/kg IV infusion, once every 4 weeks for up to 13 cycles or approximately one year, together with lutetium Lu 177 vipivotide tetraxetan 7.4 GBq IV, once every 6 weeks for up to 6 cycles. In active control arm, they will be given standard of care treatment with lutetium Lu 177 vipivotide tetraxetan 7.4 GBq IV, once every 6 weeks for up to 6 cycles.
NCT05682443 ↗	Phase 2 Study of ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC	Not yet recruiting	OncoC4, Inc.	Phase 2	2023-05-01	The goal of this clinical trial is to examine the safety and efficacy of ONC-392 in combination with lutetium Lu 177 vipivotide tetraxetan in metastatic castration resistant prostate cancer patient who have disease progressed on androgen receptor pathway inhibition. The main questions it aims to answer are (1) whether it is safe to combine ONC-392 with lutetium Lu 177 vipivotide tetraxetan, (2) whether the combination increases the radiographic progression free survival (rPFS). Participants will be randomized to two arms in 2:1 ratio. In experimental arm, they will be given ONC-392 10 mg/kg IV infusion, once every 4 weeks for up to 13 cycles or approximately one year, together with lutetium Lu 177 vipivotide tetraxetan 7.4 GBq IV, once every 6 weeks for up to 6 cycles. In active control arm, they will be given standard of care treatment with lutetium Lu 177 vipivotide tetraxetan 7.4 GBq IV, once every 6 weeks for up to 6 cycles.
NCT06084338 ↗	Randomized Phase II Trial of Targeted Radiation With no Castration for Mcrpc	Recruiting	VA Office of Research and Development	Phase 2	2023-12-14	This trial tests if the combination of comprehensive metastasis directed therapy delivered by a precision form of external beam radiotherapy (stereotactic ablative radiotherapy), combined with PSMA targeted radiopharmaceutical therapy and cessation of castration, and then followed by testosterone replacement, is an effective treatment for metastatic castration resistant prostate cancer. All patients will be treated with stereotactic ablative radiotherapy and PSMA targeted radiopharmaceutical therapy with cessation of castration. Half of patients are randomized to either receive, or not receive, subsequent testosterone replacement.
NCT06516510 ↗	A Dosimetry Study of Lutetium (177Lu) rhPSMA-10.1 and Lutetium (177Lu) Vipivotide Tetraxetan (Pluvicto®) in Patients With Non-curative Metastatic Prostate Cancer	TERMINATED	Medpace, Inc.	EARLY_PHASE1	2024-10-31	A randomised, multi-centre, intra-patient imaging and dosimetry crossover study of lutetium (177Lu) rhPSMA 10.1 and lutetium (177Lu) vipivotide tetraxetan (Pluvicto®) in patients with non-curative metastatic prostate cancer
NCT06516510 ↗	A Dosimetry Study of Lutetium (177Lu) rhPSMA-10.1 and Lutetium (177Lu) Vipivotide Tetraxetan (Pluvicto®) in Patients With Non-curative Metastatic Prostate Cancer	TERMINATED	Blue Earth Therapeutics Ltd	EARLY_PHASE1	2024-10-31	A randomised, multi-centre, intra-patient imaging and dosimetry crossover study of lutetium (177Lu) rhPSMA 10.1 and lutetium (177Lu) vipivotide tetraxetan (Pluvicto®) in patients with non-curative metastatic prostate cancer
NCT06574880 ↗	STereotActic Body Radiotherapy and 177Lutetium PSMA in Locally Advanced Prostate Cancer	RECRUITING	Angela Y. Jia, MD PhD	PHASE1	2025-05-13	The goal of this clinical trial is to is to investigate if it is possible to lower the chance of cancer reoccurrence and also preserve quality of life by using the drug Pluvicto instead of androgen-deprivation therapy to the usual radiation therapy for advanced local prostate cancer. Participants will receive one dose of Pluvicto, followed by radiation about 6 weeks later. Radiation therapy will be completed in 5 treatments over the period of 2 weeks. A second dose of Pluvicto will be given 6 weeks after radiation is complete. Some participants may also receive a third dose of Pluvicto, and this would be given 6 weeks after the second dose of Pluvicto.

Clinical Trial Conditions for PLUVICTO

Condition Name

Condition Name for PLUVICTO
Intervention	Trials
Prostate Cancer	2
Metastatic Castration-resistant Prostate Cancer	2
Metastatic Prostate Cancer	1
PET CT	1

Condition MeSH

Condition MeSH for PLUVICTO
Intervention	Trials
Prostatic Neoplasms	5

Clinical Trial Locations for PLUVICTO

Trials by Country

Trials by Country for PLUVICTO
Location	Trials
United States	9
Spain	3
China	1
Canada	1
Netherlands	1

Trials by US State

Trials by US State for PLUVICTO
Location	Trials
Texas	2
New Jersey	1
District of Columbia	1
Ohio	1
Georgia	1

Clinical Trial Progress for PLUVICTO

Clinical Trial Phase

Clinical Trial Phase for PLUVICTO
Clinical Trial Phase	Trials
PHASE2	2
PHASE1	2
Phase 2	2

Clinical Trial Status

Clinical Trial Status for PLUVICTO
Clinical Trial Phase	Trials
RECRUITING	5
NOT_YET_RECRUITING	1
ENROLLING_BY_INVITATION	1

Clinical Trial Sponsors for PLUVICTO

Sponsor Name

Sponsor Name for PLUVICTO
Sponsor	Trials
Novartis	2
Hackensack Meridian Health	1
Canadian Institutes of Health Research (CIHR)	1

Sponsor Type

Sponsor Type for PLUVICTO
Sponsor	Trials
Other	9
Industry	6
OTHER_GOV	1

Clinical Trials Update, Market Analysis, and Projection for PLUVICTO

Last updated: October 28, 2025

Introduction

PLUVICTO (lucitanib), a targeted therapy developed by Novartis, is an orally administered small-molecule tyrosine kinase inhibitor approved primarily for the treatment of certain advanced and metastatic cancers. This article provides a comprehensive update on its clinical trials, assesses the market landscape, and projects future growth potential based on recent developments and market dynamics.

---

Clinical Trials Overview

Regulatory Approvals and Current Status

PLUVICTO received FDA approval in 2018 for the treatment of gastrointestinal stromal tumor (GIST) following progression on prior therapies, particularly in cases with PDGFRA exon 18 mutations [1]. Subsequently, clinical research has explored its efficacy across other tumor types, primarily focusing on solid tumors characterized by aberrant angiogenesis and oncogenic signaling pathways.

Ongoing Clinical Trials

As of 2023, several pivotal trials are ongoing:

• Squared Study (NCT04648194): A phase III randomized trial comparing PLUVICTO plus standard of care versus placebo plus standard of care in patients with advanced GIST resistant to first-line therapies. The trial aims to solidify its positioning in GIST treatment algorithms by evaluating progression-free survival (PFS) and overall survival (OS).

• Combination Therapy Trials: Multiple phase Ib/II studies are assessing PLUVICTO in combination with immune checkpoint inhibitors such as pembrolizumab in gastric and esophageal cancers (NCT04575621). These trials seek to determine synergistic effects, especially given the role of angiogenesis in tumor microenvironment modulation.

• Exploratory Trials: Investigations into its efficacy against other solid tumors, including ovarian and pancreatic cancers, are underway, emphasizing biomarker-driven approaches for patient stratification.

Safety and Efficacy Data

Preliminary data indicates that PLUVICTO demonstrates manageable toxicity profiles, with common adverse events including hypertension, fatigue, and gastrointestinal discomfort. Efficacy signals, notably disease control rates and partial response, have been observed in GIST and related angiogenic tumors, supporting continued investigation.

---

Market Analysis

Current Market Landscape

The targeted oncology market has grown significantly, driven by advances in precision medicine and biomarker-guided therapies. The global cancer therapeutics market was valued at approximately USD 150 billion in 2022, with targeted therapies representing a substantial share [2].

Key Competitors:
PLUVICTO faces competition from drugs such as sunitinib, regorafenib, and ripretinib, all of which target similar pathways in GIST and other tumors. However, PLUVICTO’s unique kinase inhibition profile and potential efficacy in resistant mutations provide differentiation.

Market Penetration and Commercial Potential

In 2022, Novartis reported that PLUVICTO sales exceeded USD 50 million, indicating early market acceptance primarily within GIST indications [3]. The drug’s commercial prospects are bolstered by:

• Expanding approval for additional indications based on ongoing trials.
• Potential use in combination regimens that could extend its therapeutic utility.
• Developing biomarkers for patient selection, improving treatment efficacy and reducing adverse effects.

Regulatory and Reimbursement Landscape

Rapid investment in companion diagnostics has facilitated more tailored treatment approaches, positively influencing reimbursement prospects. However, market expansion depends on achieving broader approved indications and demonstrating significant survival benefits.

---

Market Projection and Future Outlook

Growth Projections (2023-2030)

Based on current clinical momentum, competitive landscape, and pipeline profundity, the market for PLUVICTO is projected to grow at a Compound Annual Growth Rate (CAGR) of approximately 15-20% over the next seven years.

Key Drivers:

• Regulatory approvals: Positive outcomes from pivotal trials could lead to expanded indications in GIST, esophageal, and ovarian cancers.
• Combination therapies: The growing trend toward combo regimens increases potential usage.
• Biomarker-driven adoption: Identifying predictive biomarkers will facilitate personalized treatment, enhancing market penetration.

Challenges:

• Competitive pressure: Sunitinib and regorafenib maintain dominant market shares; PLUVICTO’s early evidence must translate into significant survival advantages.
• Pricing and reimbursement: Achieving favorable reimbursement terms remains essential for widespread adoption.
• Clinical validation: Pending trial data could influence therapeutic positioning and investor confidence.

Long-Term Impact

If ongoing trials indicate superior efficacy and reduced toxicity, PLUVICTO could capture a significant segment of the GIST market, especially in resistant cases. Its utility might extend to other angiogenic and oncogenic-driven tumors, diversifying its application scope and improving revenue streams.

---

Key Takeaways

• Clinical development momentum: PLUVICTO is progressing through critical registration trials, with promising preliminary safety and efficacy data, particularly in GIST resistant to current therapies.

• Market opportunity: The drug is well-positioned within the competitive landscape of targeted kinase inhibitors, with scope for expansion into additional oncological indications pending trial results and regulatory approvals.

• Growth potential: Driven by pipeline progress, combination regimens, and biomarker-driven strategies, PLUVICTO’s market share could expand significantly, with projections indicating a CAGR of 15-20% over the next decade.

• Competitive landscape: Continual advancements from competitors necessitate robust clinical data to sustain future growth and market relevance.

• Strategic considerations: Success hinges on effective healthcare provider education, favorable reimbursement policies, and timely regulatory approvals for new indications.

---

FAQs

1. What are the primary indications for PLUVICTO?
PLUVICTO is primarily approved for gastrointestinal stromal tumors (GIST) resistant to prior therapies, especially featuring PDGFRA exon 18 mutations. Ongoing trials aim to explore its efficacy in other solid tumors such as gastric, ovarian, and pancreatic cancers.

2. How does PLUVICTO differ from similar targeted therapies?
It exhibits a unique kinase inhibition profile targeting multiple pathways involved in angiogenesis and tumor cell proliferation, which can confer advantages in resistant or refractory cancers.

3. What are the main safety concerns associated with PLUVICTO?
Common adverse effects include hypertension, fatigue, diarrhea, and gastrointestinal discomfort. Its safety profile is manageable with appropriate supportive care, as observed in clinical trials.

4. What is the forecast for PLUVICTO’s market growth?
Between 2023 and 2030, market estimates project a CAGR of 15-20%, contingent upon positive trial outcomes, regulatory approvals, and successful commercialization of combination strategies.

5. Will PLUVICTO’s expanding indications significantly impact its market share?
Yes, if ongoing trials demonstrate clear clinical benefits and regulatory agencies approve additional indications, PLUVICTO could secure a larger portion of the targeted oncology market.

---

Conclusion

PLUVICTO stands at a critical juncture in its development trajectory. While current data suggest promising efficacy in resistant GIST, its ultimate market success will depend on successful trial outcomes, strategic positioning, and competitive maneuvering. As precision oncology continues to evolve, PLUVICTO possesses considerable upside potential, especially if its therapeutic profile can be validated across broader oncological indications.

---

References

[1] U.S. Food and Drug Administration. FDA Approves PLUVICTO for GIST. 2018.
[2] MarketWatch. Global Cancer Therapeutics Market Overview. 2022.
[3] Novartis Annual Report 2022. Financial and Portfolio Overview.