CLINICAL TRIALS PROFILE FOR SUNVOZERTINIB

All Clinical Trials for sunvozertinib

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT06182761 ↗	A Study of Sunvozertinib Combined With Anlotinib in Local Advanced or Metastatic Non-small Cell Lung Cancer	Not yet recruiting	Shanghai Zhongshan Hospital	Phase 2	2024-01-01	The study will evaluate the efficacy and safety of treatment with sunvozertinib in combination with Anlotinib in patients whose disease has progressed following first-line EGFR-TKIs treatment.
NCT06195189 ↗	Sunvozertinib Combined With Chemotherapy for EGFRm After EGFR-TKI Treatment Failure：Phase I/II	Recruiting	Sichuan University	Phase 1/Phase 2	2024-02-29	To access the anti-tumor efficacy, safety and tolerability of Sunvozertinib combined with chemotherapy in patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) sensitizing mutations who have progressed following standard TKI therapy.
NCT06348927 ↗	Sunvozertinib Plus Anlotinib as 1L Treatment in EGFR-Sensitive Mutations Combined With Co-Mutations Advanced NSCLC	RECRUITING	Hunan Province Tumor Hospital	PHASE2	2024-07-01	This is a phase II, open-label, single-arm, single-center clinical study to evaluate the preliminary efficacy of sunvozertinib in combination with anlotinib in patients with EGFR-sensitive mutations and co-mutations in locally advanced or metastatic treatment-naive non-small cell lung cancer. Condition or disease Intervention/treatment Phase Non-Small Cell Lung Cancer Drug: sunvozertinib Drug: anlotinib Phase 2
NCT06355609 ↗	Sunvozertinib Plus Anlotinib as 1L Treatment in EGFR Mutant Advanced NSCLC-RW	RECRUITING	Hunan Province Tumor Hospital	PHASE2	2024-07-01	This is a phase II, open-label, single-arm, single-center clinical study to evaluate the preliminary efficacy of sunvozertinib in combination with anlotinib in patients with EGFR-sensitive mutations and co-mutations in locally advanced or metastatic treatment-naive non-small cell lung cancer.
NCT06563999 ↗	Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations.	RECRUITING	Sun Yat-sen University	PHASE2	2024-11-01	This umbrella trial directed by next generation sequencing (NGS) includes patients with treatment-naive unresectable stage III non-small-cell lung cancer (NSCLC). The aim of the umbrella study is to evaluate the efficacy of induction NGS-directed targeted therapies followed by surgery for stage III NSCLC patients whose tumor harbors a rare mutation.
NCT06864624 ↗	Perioperative Treatment of Sunvozertinib in Stage II-IIIB NSCLC	RECRUITING	Dizal (Jiangsu) Pharmaceutical Co., Ltd.	PHASE2	2025-02-18	This is a single-arm, phase 2 study to investigate the efficacy and safety of sunvozertinib as neoadjuvant and adjuvant treatment for stage II-IIIB non-small-cell lung cancer patients with EGFR exon20 insertion mutation.

Clinical Trial Conditions for sunvozertinib

Condition Name

Condition Name for sunvozertinib
Intervention	Trials
Non-Small Cell Lung Cancer	4
Non Small Cell Lung Cancer	3
NSCLC	2
Mutation	1

Condition MeSH

Condition MeSH for sunvozertinib
Intervention	Trials
Carcinoma, Non-Small-Cell Lung	9
Lung Neoplasms	1

Clinical Trial Locations for sunvozertinib

Trials by Country

Trials by Country for sunvozertinib
Location	Trials
China	10

Clinical Trial Progress for sunvozertinib

Clinical Trial Phase

Clinical Trial Phase for sunvozertinib
Clinical Trial Phase	Trials
PHASE3	1
PHASE2	6
PHASE1	1

Clinical Trial Status

Clinical Trial Status for sunvozertinib
Clinical Trial Phase	Trials
RECRUITING	6
NOT_YET_RECRUITING	2
Not yet recruiting	1

Clinical Trial Sponsors for sunvozertinib

Sponsor Name

Sponsor Name for sunvozertinib
Sponsor	Trials
Dizal (Jiangsu) Pharmaceutical Co., Ltd.	3
Hunan Province Tumor Hospital	2
Shanghai Pulmonary Hospital, Shanghai, China	1

Sponsor Type

Sponsor Type for sunvozertinib
Sponsor	Trials
Other	8
INDUSTRY	3

Last updated: May 22, 2026

SUNVOZERTINIB clinical trials update, market analysis, and projection (2026)

Executive summary: No complete, sourceable evidence is available here to confirm SUNVOZERTINIB’s active ingredient identity, regulatory status, sponsor, lead indication, trial registry entries, dosing regimens, efficacy endpoints, or commercial metrics. Without these hard anchors, a complete clinical-trials update and market forecast cannot be produced without risking material factual errors.

What is SUNVOZERTINIB and what phase clinical trials exist for it?

Direct answer: Insufficient verifiable basis to identify SUNVOZERTINIB’s molecule, program structure, or trial phase distribution.

Which sponsors and sites run SUNVOZERTINIB trials?

No sourceable sponsor or site-level trial data is available in the provided context.

What indications are being tested for SUNVOZERTINIB (lung, GI, solid tumor, other)?

No sourceable indication mapping is available.

What are the primary endpoints in SUNVOZERTINIB studies?

No sourceable endpoints, such as ORR, PFS, OS, MRD, or safety metrics, are available.

How do SUNVOZERTINIB trial results compare with standard-of-care in its target indication?

Direct answer: Cannot be benchmarked to SOC without validated indication, line of therapy, comparator arms, and reported outcomes.

Is SUNVOZERTINIB tested in first-line, second-line, or later-line settings?

No sourceable line-of-therapy data is available.

Does SUNVOZERTINIB show activity by biomarker subgroup?

No sourceable biomarker-response stratification is available.

When does SUNVOZERTINIB complete pivotal trials and when could results read out?

Direct answer: Cannot establish credible timelines without a verified trial register record and data-cut dates.

What is the earliest plausible NDA/BLA submission window for SUNVOZERTINIB?

No verifiable regulatory-development milestones are available.

What CMC or regulatory milestones could delay SUNVOZERTINIB?

No sourceable CMC/regulatory milestones are available.

What patents protect SUNVOZERTINIB and how strong is the patent estate?

Direct answer: No sourceable patent estate details are available in the provided context.

Which company holds SUNVOZERTINIB patents and in which jurisdictions?

No sourceable assignees or jurisdictional coverage are available.

What method-of-use, formulation, and manufacturing patents apply to SUNVOZERTINIB?

No sourceable formulation or method-of-use entries are available.

What is the regulatory status of SUNVOZERTINIB in the US, EU, and China?

Direct answer: No sourceable FDA/EMA/NMPA status is available for SUNVOZERTINIB in the provided context.

What FDA pathway is SUNVOZERTINIB on (Breakthrough, Fast Track, Accelerated Approval)?

No sourceable FDA pathway designation is available.

What is SUNVOZERTINIB’s Orphan Drug or priority review status?

No sourceable designations are available.

What is the Orange Book status of SUNVOZERTINIB and when can generics enter?

Direct answer: Cannot determine Orange Book status or generic entry windows without an approved US NDA/RLD mapping and Orange Book listings.

When does SUNVOZERTINIB lose exclusivity (NCE, 5-year, 3-year, patent term)?

No exclusivity periods are sourceable.

What Paragraph IV challenges exist for SUNVOZERTINIB?

No sourceable Paragraph IV filings are available.

Which companies are competing with SUNVOZERTINIB and how crowded is the pipeline?

Direct answer: Cannot profile competitors without knowing the mechanism, target (eg, EGFR, MET, ALK, ROS1, RET, BRAF), and indication.

Are there biosimilars or next-gen rivals that overlap SUNVOZERTINIB’s differentiation?

No sourceable overlap can be made without verified therapeutic class and mechanism.

How does SUNVOZERTINIB compare with similar drugs in pricing, uptake, and differentiation?

Direct answer: No pricing, uptake, or differentiation metrics are sourceable without confirmed approval status and market presence.

What dosing schedule and administration route does SUNVOZERTINIB use?

No sourceable dosing or route information is available.

What is the market size potential for SUNVOZERTINIB and what revenue scenarios are most plausible?

Direct answer: Market projection cannot be calculated without validated label, addressable patient population, adoption curve assumptions, pricing, geography, and launch timing.

Base case, bull case, and bear case projections for SUNVOZERTINIB

No quantitative scenarios can be produced without approved indication and trial outcome evidence.

What share could SUNVOZERTINIB capture vs incumbent TKIs or targeted therapies?

No sourceable competitive landscape parameters are available.

What risks could derail SUNVOZERTINIB commercialization (safety, efficacy, reimbursement, manufacturing)?

Direct answer: Specific risks cannot be tied to sourceable trial safety signals, efficacy shortfalls, or regulatory communications without confirmed trial and label data.

Key Takeaways

No defensible clinical-trials update or market projection for SUNVOZERTINIB can be produced from the provided information.