Non-Small Cell Lung CancerPhase 3NCT07182682

A Phase 3 Study of Sunvozertinib Versus Placebo as Adjuvant Therapy in Patients With Early-Stage Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations or PACC Mutations After Radical Surgery

A Phase 3 study testing sunvozertinib in people with Non-Small Cell Lung Cancer, run by Dizal (Jiangsu) Pharmaceutical Co., Ltd. at 49 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

To assess the efficacy and safety of sunvozertinib versus placebo as adjuvant therapy in patients with stage IB-IIIA non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins) or P-loop and αC-helix compression (PACC) mutations, who have had radical… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-Small Cell Lung Cancer
What is being tested?: sunvozertinib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 360 participants
Where: 49 sitesChina
Study dates: 1 Dec 2025to Jan 2031
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Provide a signed and dated informed consent form (ICF) prior to any study specific procedures, sampling, and analyses.
Aged at least 18 years old at the time of ICF signature.
Complete resection (R0) of the primary tumor and histologically confirmed diagnosis of NSCLC (participants with tumor histology indicative of neuroendocrine carcinoma, sarcomatoid carcinoma, or small cell lung cancer should be excluded).
Complete surgical resection of the primary NSCLC is mandatory. All gross lesions must be completely resected to achieve microscopically negative margins. Hilar and mediastinal lymph node dissection should be performed per clinical guidelines.
Acceptable surgery type: lobectomy, sleeve lobectomy, bilobectomy, or pneumonectomy.
Acceptable surgery approach: thoracotomy or thoracoscopic surgery.

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Participants must have NSCLC classified post-operatively as stage IB, II, or IIIA according to the AJCC TNM staging 9.0th edition.
Have documented EGFR exon20ins (Cohort 1) or EGFR PACC mutations (Cohort 2) from a local Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory (or equivalent).
Common EGFR PACC mutations include, but not limited to, L718Q, G719X, S768I, L747P/S, V769L, E709_T710delinsD, L792H, and T854I.
Participants must provide sufficient tumor tissue samples for confirmation of EGFR mutations by the sponsor designated central laboratory.
ECOG performance status is 0 or 1.
Participants must recover from prior lung surgery and systemic therapy (e.g., neoadjuvant therapy and/or adjuvant chemotherapy) without Grade 1 or higher AEs (except alopecia of any grade and ≤ Grade 2 platinum-associated neuropathy) at randomization.
Participants who have not previously received adjuvant chemotherapy should be randomized as early as 4 weeks and within 10 weeks after the radical surgery.
Participants who have previously received adjuvant chemotherapy can be randomized within 2 - 10 weeks of completion of adjuvant chemotherapy with a maximum interval of no more than 26 weeks from surgery to randomization. The adjuvant chemotherapy can start as early as 4 weeks after the radical surgery, in 21-day cycles, and up to 4 cycles.
Adequate bone marrow reservation or organ functions within 7 days prior to randomization.
Male participants with female partners of child-bearing potential should use barrier contraceptives (e.g., by use of condoms), during their participation in this study and for 6 months following the last dose of the study drug. Male participants must refrain from donating sperm during their participation in the study and for 6 months following the last dose of the study drug. If male participants wish to father children, they should be advised to arrange for freezing of sperm samples prior to the start of study drug.
Female participants of child-bearing potential should use reliable contraceptives from the time of screening until 2 months after discontinuation of study drug. Female participants should not be breast feeding and must have a negative pregnancy test (serum or urine β-human chorionic gonadotropin) prior to start dosing or must fulfil one of the following criteria at screening:
Post-menopausal defined as aged at least 50 years old and amenorrhea for at least 12 months following cessation of all exogenous hormonal treatment.
Women under 50 years old would be considered postmenopausal if they have been amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments and with luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the post-menopausal range.
Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.

Who cannot join

Concurrent EGFR sensitizing mutations (L858R and/or exon 19 deletion) or other driver gene variations with available standard therapies (e.g., ALK positive).
Participants who have had only segmentectomies or wedge resections.
Participants who have received any preoperative or postoperative radiotherapy for NSCLC, or who plan to have radiotherapy during the study.
Participants who have received any EGFR TKIs as (neo)adjuvant therapy for NSCLC or have known pathological complete response from previous neoadjuvant therapy.
Participants who are receiving (or unable to stop) medications or herbs known to be strong CYP3A inducers within 2 weeks prior to randomization.
Previous history of interstitial lung disease (ILD), drug-induced ILD, or radiation pneumonitis requiring steroid therapy, any evidence of clinically active ILD, or immunotherapy induced pneumonitis.

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Any serious or uncontrolled systemic disease requiring treatment, including uncontrolled hypertension, diabetes, chronic heart failure and active bleeding disorders (such as hemophilia, von Willebrand disease), etc., which in the opinion of the investigator is not suitable for participation in the trial or will affect compliance with the protocol; or active infection, including hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
Any of the following cardiac criteria:
Mean resting corrected QT interval (QTc) > 470 msec on 3 ECGs at screening
Any clinically significant abnormalities in rhythm, conduction or morphology of resting ECG, e.g., complete left bundle branch block, third degree heart block, and second-degree heart block, PR interval > 250 msec.
Any factors that increase the risk of QTc prolongation, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years old in first degree relatives or any concomitant medication known to prolong the QT interval.
Prior history of atrial fibrillation within 6 months of the first dose of study drug, except for those related to drug treatment and recovered.
Participants with a history of any malignancy, except for adequately treated non-melanoma skin cancer, carcinoma in situ or other solid tumors with >5 years since completion of anti-cancer therapy and no evidence of disease recurrence at randomization
Refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow the formulated product, or previous major bowel resection that may preclude adequate absorption of sunvozertinib.
Hypersensitivity to sunvozertinib, excipients of sunvozertinib, or drugs of similar chemical structure or same class.
Involvement in the design, planning or conduct of this study (applicable to Dizal staff or study site staff).
Judgment by the investigator that the participant is unlikely to comply with study procedures, restrictions or requirements.

Trial locations and contacts

49 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Sherry Hu, MD, PhD contact

+86 2161098345

sherry.hu@dizalpharma.com

City, postcode or hospital

Sites recruiting now only

49 sites in 1 country

China49 sites, 49 recruiting

Beijing Cancer Hospital
Beijing
Not yet recruiting
Beijing Chest Hospital, Capital medical university
Beijing
Not yet recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing
Not yet recruiting
China-Japan Friendship hospital
Beijing
Not yet recruiting
Peking Union Medical College Hospital
Beijing
Not yet recruiting
Xuanwu Hospital Capital Medical University
Beijing
Not yet recruiting
The First Hospital of Jilin University
Changchun
Recruiting
Hunan Cancer Hospital
Changsha
Not yet recruiting
The Third Xiangya Hospital of Central South University
Changsha
Not yet recruiting
Xiangya Hospital of Central South University
Changsha
Not yet recruiting
Sichuan Cancer Hospital
Chengdu
Not yet recruiting
West China Hospital Sichuan University
Chengdu
Not yet recruiting
Fujian Cancer Hospital
Fuzhou
Not yet recruiting
Fujian Medical University Union Hospital
Fuzhou
Not yet recruiting
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou
Not yet recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou
Not yet recruiting
Sun Yat-sen University Cancer Center
Guangzhou
Not yet recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou
Not yet recruiting
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou
Not yet recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou
Not yet recruiting
Zhejiang Cancer Hospital
Hangzhou
Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin
Not yet recruiting
Anhui Provincial Cancer Hospital
Hefei
Recruiting
Jinan Central Hospital
Jinan
Not yet recruiting
Shandong Cancer Hospital
Jinan
Recruiting
Yunnan Cancer Hospital
Kunming
Not yet recruiting
Jiangxi Provincial People 's Hospital
Nanchang
Not yet recruiting
Jiangsu Province Hospital
Nanjing
Not yet recruiting
Nanjing Chest Hospital
Nanjing
Not yet recruiting
Guangxi Medical University Cancer Hospital
Nanning
Not yet recruiting
Fudan University Shanghai Cancer Center
Shanghai
Not yet recruiting
Shanghai Chest Hospital
Shanghai
Not yet recruiting
Shanghai East Hospital
Shanghai
Not yet recruiting
Shanghai Pulmonary Hospital
Shanghai
Recruiting
Zhongshan Hospital Fudan University
Shanghai
Not yet recruiting
Liaoning Cancer Hospital & Institute
Shenyang
Not yet recruiting
The First Hospital of China Medical University
Shenyang
Not yet recruiting
Shanxi Cancer hospital (Shanxi Cancer institute)
Taiyuan
Not yet recruiting
Shanxi Provincial people's hospital
Taiyuan
Not yet recruiting
Taizhou Hospital, Zhejiang Province
Taizhou
Not yet recruiting
Tianjin Chest Hospital
Tianjin
Not yet recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin
Not yet recruiting
Tianjin Medical University General Hospital
Tianjin
Not yet recruiting
Hubei Cancer Hospital
Wuhan
Not yet recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Not yet recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an
Not yet recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou
Not yet recruiting
Henan Cancer Hospital
Zhengzhou
Not yet recruiting
The first affiliated hospital of Zhengzhou University
Zhengzhou
Not yet recruiting

Other trials in China

About this study

Official title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Anti-Tumor Efficacy and Safety of Sunvozertinib Versus Placebo as Adjuvant Therapy in Patients With Stage IB-IIIA Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations or PACC Mutations After Radical Surgery (WU-KONG16)

Conditions: Non-Small Cell Lung Cancer
Being tested: sunvozertinib, Matching Placebo
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

sunvozertinibDrug
Participants will receive oral administration of sunvozertinib 200 mg QD following randomization, with each treatment cycle defined as 21 days, until meeting any treatment discontinuation criteria (i.e, objective disease recurrence, intolerable adverse event [AE], completion of 3-year [156-week] treatment period, study termination, death, treatment or study withdrawal by participants, whichever occurs first).
Matching PlaceboDrug
Participants will receive oral administration of placebo 200 mg QD following randomization, with each treatment cycle defined as 21 days, until meeting any treatment discontinuation criteria (i.e, objective disease recurrence, intolerable adverse event [AE], completion of 3-year [156-week] treatment period, study termination, death, treatment or study withdrawal by participants, whichever occurs first).

Study groups in NCT07182682
Study group	Role	What they receive
Sunvozertinib, 200 mg orally, once daily	Experimental	Not described Receives: Drug: sunvozertinib
Matching placebo, 200 mg orally, once daily	Placebo comparator	Not described Receives: Drug: Matching Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Disease-free survival (DFS) by investigator assessment
Measured: Up to approximately 5 years after the first participant is randomized

Secondary outcomes (5)

Overall survival (OS)
Measured: Up to approximately 5 years after the first participant is randomized.
DFS rate at 2, 3, and 5 years by investigator assessment
Measured: Up to approximately 5 years after the first participant is randomized.
OS rate at 2, 3 and 5 years
Measured: Up to approximately 5 years after the first participant is randomized.
Incidence of adverse event (AE) and serious adverse event (SAE)
Measured: Up to approximately 3 years after the first dose
The plasma concentration of sunvozertinib and its metabolite (DZ0753)
Measured: Up to approximately 3 years after the first dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 2025Jan 2031

First posted19 Sep 2025
Study start1 Dec 2025
Primary completionSep 2029 (estimated)
Study completionJan 2031 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 360 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07182682
Sponsor's protocol ID: DZ2025E0001
Status last verified: Dec 2025
First submitted: 3 Sep 2025
Last updated: 15 Dec 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Anti-Tumor Efficacy and Safety of Sunvozertinib Versus Placebo as Adjuvant Therapy in Patients With Stage IB-IIIA Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations or PACC Mutations After Radical Surgery (WU-KONG16)
ClinicalTrials.gov ID: NCT07182682
Acronym / sponsor ID: DZ2025E0001
Conditions: Non-Small Cell Lung Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 360 participants (estimated)
Lead sponsor: Dizal (Jiangsu) Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 1 Dec 2025 (actual)
Primary completion: Sep 2029 (estimated)
Study completion: Jan 2031 (estimated)
First posted: 19 Sep 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Sunvozertinib, 200 mg orally, once daily	Experimental	Drug: sunvozertinib
Matching placebo, 200 mg orally, once daily	Placebo comparator	Drug: Matching Placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (20 listed)

Provide a signed and dated informed consent form (ICF) prior to any study specific procedures, sampling, and analyses.
Aged at least 18 years old at the time of ICF signature.
Complete resection (R0) of the primary tumor and histologically confirmed diagnosis of NSCLC (participants with tumor histology indicative of neuroendocrine carcinoma, sarcomatoid carcinoma, or small cell lung cancer should be excluded).
Participants must have NSCLC classified post-operatively as stage IB, II, or IIIA according to the AJCC TNM staging 9.0th edition.
Have documented EGFR exon20ins (Cohort 1) or EGFR PACC mutations (Cohort 2) from a local Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory (or equivalent).

Key exclusion criteria (17 listed)

Concurrent EGFR sensitizing mutations (L858R and/or exon 19 deletion) or other driver gene variations with available standard therapies (e.g., ALK positive).
Participants who have had only segmentectomies or wedge resections.
Participants who have received any preoperative or postoperative radiotherapy for NSCLC, or who plan to have radiotherapy during the study.
Participants who have received any EGFR TKIs as (neo)adjuvant therapy for NSCLC or have known pathological complete response from previous neoadjuvant therapy.
Participants who are receiving (or unable to stop) medications or herbs known to be strong CYP3A inducers within 2 weeks prior to randomization.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
sunvozertinibParticipants will receive oral administration of sunvozertinib 200 mg QD following randomization, with each treatment cycle defined as 21 days, until meeting any treatment discontinuation criteria (i.e, objective disease recurrence, intolerable adverse event [AE], completion of 3-year [156-week] treatment period, study termination, death, treatment or study withdrawal by participants, whichever occurs first).	Drug	Sunvozertinib, 200 mg orally, once daily
Matching PlaceboParticipants will receive oral administration of placebo 200 mg QD following randomization, with each treatment cycle defined as 21 days, until meeting any treatment discontinuation criteria (i.e, objective disease recurrence, intolerable adverse event [AE], completion of 3-year [156-week] treatment period, study termination, death, treatment or study withdrawal by participants, whichever occurs first).	Drug	Matching placebo, 200 mg orally, once daily

Primary outcome

Disease-free survival (DFS) by investigator assessment
Time frame: Up to approximately 5 years after the first participant is randomized

5 secondary outcomes

Overall survival (OS)
Time frame: Up to approximately 5 years after the first participant is randomized.
DFS rate at 2, 3, and 5 years by investigator assessment
Time frame: Up to approximately 5 years after the first participant is randomized.
OS rate at 2, 3 and 5 years
Time frame: Up to approximately 5 years after the first participant is randomized.
Incidence of adverse event (AE) and serious adverse event (SAE)
Time frame: Up to approximately 3 years after the first dose
The plasma concentration of sunvozertinib and its metabolite (DZ0753)
Time frame: Up to approximately 3 years after the first dose

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Sherry Hu, MD, PhD contact

+86 2161098345

sherry.hu@dizalpharma.com

Zhou principal investigator

Shanghai East Hospital

Wang principal investigator

Tianjin Medical University Cancer Institute and Hospital

49 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing sunvozertinib in people with Non-Small Cell Lung Cancer, run by Dizal (Jiangsu) Pharmaceutical Co., Ltd. at 49 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sherry Hu, MD, PhD (+86 2161098345, sherry.hu@dizalpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free survival (DFS) by investigator assessment (time frame: Up to approximately 5 years after the first participant is randomized). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07182682.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.