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, 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)
1 other identifier
interventional
360
1 country
49
Brief 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 surgery, regardless of adjuvant chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 nonsmall-cell-lung-cancer
Started Dec 2025
Typical duration for phase_3 nonsmall-cell-lung-cancer
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 3, 2025
CompletedFirst Posted
Study publicly available on registry
September 19, 2025
CompletedStudy Start
First participant enrolled
December 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2031
December 15, 2025
December 1, 2025
3.8 years
September 3, 2025
December 11, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Disease-free survival (DFS) by investigator assessment
Up to approximately 5 years after the first participant is randomized
Secondary Outcomes (5)
Overall survival (OS)
Up to approximately 5 years after the first participant is randomized.
DFS rate at 2, 3, and 5 years by investigator assessment
Up to approximately 5 years after the first participant is randomized.
OS rate at 2, 3 and 5 years
Up to approximately 5 years after the first participant is randomized.
Incidence of adverse event (AE) and serious adverse event (SAE)
Up to approximately 3 years after the first dose
The plasma concentration of sunvozertinib and its metabolite (DZ0753)
Up to approximately 3 years after the first dose
Study Arms (2)
Sunvozertinib, 200 mg orally, once daily
EXPERIMENTALMatching placebo, 200 mg orally, once daily
PLACEBO COMPARATORInterventions
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).
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).
Eligibility Criteria
You may qualify if:
- 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.
- 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.
- +5 more criteria
You may not qualify if:
- 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.
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (49)
Beijing Cancer Hospital
Beijing, China
Beijing Chest Hospital, Capital medical university
Beijing, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
China-Japan Friendship hospital
Beijing, China
Peking Union Medical College Hospital
Beijing, China
Xuanwu Hospital Capital Medical University
Beijing, China
The First Hospital of Jilin University
Changchun, China
Hunan Cancer Hospital
Changsha, China
The Third Xiangya Hospital of Central South University
Changsha, China
Xiangya Hospital of Central South University
Changsha, China
Sichuan Cancer Hospital
Chengdu, China
West China Hospital Sichuan University
Chengdu, China
Fujian Cancer Hospital
Fuzhou, China
Fujian Medical University Union Hospital
Fuzhou, China
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, China
Sun Yat-sen University Cancer Center
Guangzhou, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, China
Zhejiang Cancer Hospital
Hangzhou, China
Harbin Medical University Cancer Hospital
Harbin, China
Anhui Provincial Cancer Hospital
Hefei, China
Jinan Central Hospital
Jinan, China
Shandong Cancer Hospital
Jinan, China
Yunnan Cancer Hospital
Kunming, China
Jiangxi Provincial People 's Hospital
Nanchang, China
Jiangsu Province Hospital
Nanjing, China
Nanjing Chest Hospital
Nanjing, China
Guangxi Medical University Cancer Hospital
Nanning, China
Fudan University Shanghai Cancer Center
Shanghai, China
Shanghai Chest Hospital
Shanghai, China
Shanghai East Hospital
Shanghai, China
Shanghai Pulmonary Hospital
Shanghai, China
Zhongshan Hospital Fudan University
Shanghai, China
Liaoning Cancer Hospital & Institute
Shenyang, China
The First Hospital of China Medical University
Shenyang, China
Shanxi Cancer hospital (Shanxi Cancer institute)
Taiyuan, China
Shanxi Provincial people's hospital
Taiyuan, China
Taizhou Hospital, Zhejiang Province
Taizhou, China
Tianjin Chest Hospital
Tianjin, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
Tianjin Medical University General Hospital
Tianjin, China
Hubei Cancer Hospital
Wuhan, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, China
Henan Cancer Hospital
Zhengzhou, China
The first affiliated hospital of Zhengzhou University
Zhengzhou, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhou
Shanghai East Hospital
- PRINCIPAL INVESTIGATOR
Wang
Tianjin Medical University Cancer Institute and Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 3, 2025
First Posted
September 19, 2025
Study Start
December 1, 2025
Primary Completion (Estimated)
September 1, 2029
Study Completion (Estimated)
January 1, 2031
Last Updated
December 15, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share