NSCLCPhase 2WU-KONG20NCT06864624
Perioperative Treatment of Sunvozertinib in Stage II-IIIB NSCLC
A Phase 2 study testing Sunvozertinib in people with NSCLC, run by Tang-Du Hospital at 3 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- Sunvozertinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 3 sitesChina
- Study dates
- 18 Feb 2025to Jun 2029
- Phase
- Phase 2
- 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
- Patients must understand the requirements and content of the clinical trial and provide a handwritten signed and dated informed consent.
- Age ≥ 18 years old.
- Non-small cell lung cancer confirmed by histopathology or cytology, clinical stage II, IIIA or IIIB (N2) assessed by the investigator according to AJCC 8th edition.
- EGFR exon 20 insertion mutation confirmed by an approved local laboratory.
- No disease progression in the past two weeks of signing the informed consent form and a score of 0-1 according to the ECOG criteria, and no significant progression within 2 weeks before the first dose.
- At least one measurable target lesion according to RECIST v1.1.
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- Adequate bone marrow and other organ reserve:
- Absolute neutrophil count (ANC) ≥ 1.5 × 109/L
- Platelets ≥ 100 × 109/L
- Hemoglobin ≥ 9 g/dL
- Total bilirubin ≤ 1.5 ×ULN; in patients with Gilbert syndrome, total bilirubin ≤ 3 × ULN
- ALT≤ 2.5 × ULN and AST≤ 2.5 × ULN
- Creatinine ≤ 1.5 × ULN, and creatinine clearance calculated the Cockcroft-Gault method ≥ 60 mL/min
- International normalized ratio (INR) ≤ 1.5 × ULN
- Partial thromboplastin time (APTT) ≤ 1.5 × ULN
- Male patients who wish to have children should use barrier contraception (such as condoms) during the clinical trial period and 6 months after the last dose. Male patients should not donate sperm during the clinical trial period and 6 months after the last dose.
- Female patients should take contraceptive measures from the start of screening to the 6 weeks after last dose, should not breastfeed, and should have a negative pregnancy test (blood or urine β-human chorionic gonadotropin) at screening.
Who cannot join
- Patients who have received the following treatments must be excluded:
- Any systemic anti-tumor treatment, including radiotherapy;
- Other drugs in the development stage, if the medication does not exceed 28 days and has not undergone any tumor assessment, the medication must be stopped for more than 5 half-lives and the patient can be enrolled after consultation with the investigator.
- Traditional Chinese medicine and other drugs with strong P450 (CYP)3A4 inhibitory or inducing effects are currently being used or cannot be stopped. There must be a washout period of at least 1 week before the first dose.
- A history of other malignant tumors other than lung cancer within 2 years (except for basal cell carcinoma of the skin or in situ cervical cancer that has been adequately treated and has no evidence of recurrence during the screening period).
- Before the first dose, there are adverse events of CTCAE > 1 grade (except for any degree of alopecia) caused by previous treatment (such as diagnostic puncture, use of other drugs, etc.).
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- History of stroke or intracranial hemorrhage within 6 months before the first dose.
- According to the investigator's judgment, the presence of any severe or poorly controlled systemic disease, including any of the following poorly controlled heart-related diseases or abnormalities:
- The resting electrocardiogram shows a calibrated QTc interval (QTcF) > 470 msec
- The resting electrocardiogram shows any serious abnormalities in heart rhythm, conduction or pattern, such as complete left bundle branch block, third-degree heart block, second-degree heart block, PR interval > 250 msec
- Any factors that can cause QTcF prolongation or arrhythmia, such as heart failure, hypokalemia, congenital long QT syndrome, family history of QT syndrome or other sudden death diseases under 40 years old, or other diseases known to cause QT prolongation
- Suffering from atrial fibrillation (except for drug-induced and recovered after discontinuation of the drug)
- Myocardial infarction within 6 months before the first dose, New York Heart Association grade 2 congestive heart failure, or arrhythmias that are not well controlled by drugs
- Patients with a history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid hormone treatment, or any clinically active interstitial lung disease, or immune pneumonitis caused by immunotherapy.
- Patients with refractory nausea and vomiting, chronic gastrointestinal diseases, difficulty in swallowing medication, or previous intestinal resection that prevents adequate absorption of sunvozertinib.
- Women who are breastfeeding or pregnant.
- Patients who are allergic to the drug components of sunvozertinib.
- Patients who are assessed by the investigator as being unable to undergo clinical trials, unable to tolerate surgery, or who may lack compliance with clinical trials should not participate in this study.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Not yet recruiting
Second Xiangya Hospital of Central South University
Changsha, Hunan
Wenliang Liu, +8673185296122, liuwenliang@csu.edu.cn
- Recruiting
Tangdu Hospital
Xi'an, Shaanxi
Shicao Li, +86 02984777631, tangduec@126.com
Xiaolong Yan
- Not yet recruiting
General Hospital of Ningxia Medical University
Yinchuan, Ningxia
Jinxi He, +8609516745960, nypxwk@163.com
About this study
Official title: Sunvozertinib as Neoadjuvant and Adjuvant Therapy in Stage II-IIIB Non-small-cell Lung Cancer Patients With EGFR Exon 20 Insertion Mutation: a Single-arm, Phase 2 Study (WU-KONG20)
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.
- Conditions
- NSCLC
- Being tested
- Sunvozertinib
- Keywords
- sunvozertinib, neoadjuvant, adjuvant, EGFR exon20 insertion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SunvozertinibDrug
Neoadjuvant stage: 300mg for 12 weeks Adjuvant stage: 300mg for first 4 weeks, then 150mg for up to 2 years
| Study group | Role | What they receive |
|---|---|---|
| sunvozertinib | Experimental | Patients will receive neoadjuvant sunvozertinib for 12 weeks, and continue adjuvant sunvozertinib after surgery until disease relapse, unacceptable toxicity, or the end of 2-years adjuvant treatment. Receives: Drug: Sunvozertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) of neoadjuvant therapy
Complete response (CR) or partial response (PR) per investigator assessment according to RECIST 1.1
Measured: From enrollment to the end of neoadjuvant therapy at 12 weeks
Secondary outcomes (8)
Major pathological response (MPR)
Measured: Pathological detection within 1month after surgery
Pathological complete response (pCR)
Measured: Pathological detection within 1 month after surgery
Downstaging rate of N2 lymph nodes
Measured: From enrollment to the end of neoadjuvant therapy at 12 weeks
Disease control rate (DCR) of neoadjuvant therapy
Measured: From enrollment to the end of neoadjuvant therapy at 12 weeks
Event free survival (EFS)
Measured: From date of enrollment until the date of first documented disease progression, relapse, or death due to any cause progression, whichever came first, assessed up to 60 months
Disease free survival (DFS)
Measured: From date of surgical resection until the date of first documented disease relapse or death due to any cause , whichever came first, assessed up to 56 months
Overall survival (OS)
Measured: From date of enrollment until the date of death due to any cause , assessed up to 84 months
Adverse events
Measured: From date of enrollment until the end of the study, assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start18 Feb 2025
- Primary completionDec 2026 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dizal (Jiangsu) Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06864624
- Sponsor's protocol ID
- K202412-18
- Acronym
- WU-KONG20
- Status last verified
- Jul 2025
- First submitted
- 14 Jan 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- 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 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sunvozertinib as Neoadjuvant and Adjuvant Therapy in Stage II-IIIB Non-small-cell Lung Cancer Patients With EGFR Exon 20 Insertion Mutation: a Single-arm, Phase 2 Study (WU-KONG20)
- ClinicalTrials.gov ID
- NCT06864624
- Acronym / sponsor ID
- WU-KONG20 / K202412-18
- Conditions
- NSCLC
- Keywords
- sunvozertinib, neoadjuvant, adjuvant, EGFR exon20 insertion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Collaborators
- Dizal (Jiangsu) Pharmaceutical Co., Ltd.
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 7 Mar 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sunvozertinib | Experimental | Drug: SunvozertinibPatients will receive neoadjuvant sunvozertinib for 12 weeks, and continue adjuvant sunvozertinib after surgery until disease relapse, unacceptable toxicity, or the end of 2-years adjuvant treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients must understand the requirements and content of the clinical trial and provide a handwritten signed and dated informed consent.
- Age ≥ 18 years old.
- Non-small cell lung cancer confirmed by histopathology or cytology, clinical stage II, IIIA or IIIB (N2) assessed by the investigator according to AJCC 8th edition.
- EGFR exon 20 insertion mutation confirmed by an approved local laboratory.
- No disease progression in the past two weeks of signing the informed consent form and a score of 0-1 according to the ECOG criteria, and no significant progression within 2 weeks before the first dose.
Key exclusion criteria (18 listed)
- Patients who have received the following treatments must be excluded:
- A history of other malignant tumors other than lung cancer within 2 years (except for basal cell carcinoma of the skin or in situ cervical cancer that has been adequately treated and has no evidence of recurrence during the screening period).
- Before the first dose, there are adverse events of CTCAE > 1 grade (except for any degree of alopecia) caused by previous treatment (such as diagnostic puncture, use of other drugs, etc.).
- History of stroke or intracranial hemorrhage within 6 months before the first dose.
- According to the investigator's judgment, the presence of any severe or poorly controlled systemic disease, including any of the following poorly controlled heart-related diseases or abnormalities:
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 |
|---|---|---|
| SunvozertinibNeoadjuvant stage: 300mg for 12 weeks Adjuvant stage: 300mg for first 4 weeks, then 150mg for up to 2 years | Drug | sunvozertinib |
Primary outcome
Objective response rate (ORR) of neoadjuvant therapy
Time frame: From enrollment to the end of neoadjuvant therapy at 12 weeks
Complete response (CR) or partial response (PR) per investigator assessment according to RECIST 1.1
8 secondary outcomes
Major pathological response (MPR)
Time frame: Pathological detection within 1month after surgery
Pathological complete response (pCR)
Time frame: Pathological detection within 1 month after surgery
Downstaging rate of N2 lymph nodes
Time frame: From enrollment to the end of neoadjuvant therapy at 12 weeks
Disease control rate (DCR) of neoadjuvant therapy
Time frame: From enrollment to the end of neoadjuvant therapy at 12 weeks
Event free survival (EFS)
Time frame: From date of enrollment until the date of first documented disease progression, relapse, or death due to any cause progression, whichever came first, assessed up to 60 months
Disease free survival (DFS)
Time frame: From date of surgical resection until the date of first documented disease relapse or death due to any cause , whichever came first, assessed up to 56 months
Overall survival (OS)
Time frame: From date of enrollment until the date of death due to any cause , assessed up to 84 months
Adverse events
Time frame: From date of enrollment until the end of the study, assessed up to 36 months
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 25 Jul 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sunvozertinib in people with NSCLC, run by Tang-Du Hospital at 3 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 17 inclusion and 18 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 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Xiaolong Yan (+86 15991269383, yanxiaolong@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) of neoadjuvant therapy (time frame: From enrollment to the end of neoadjuvant therapy at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jul 2025.