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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Perioperative Treatment of Sunvozertinib in Stage II-IIIB NSCLC

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)

Perioperative Treatment of Sunvozertinib in Stage II-IIIB NSCLC (NCT06864624) is a Phase 2 interventional studying NSCLC, sponsored by Tang-Du Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against NSCLC and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 27 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Patients must understand the requirements and content of the clinical trial and provide a handwritten signed and dated willing to sign a consent form. 2. Age ≥ 18 years old. 3. 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. 4. EGFR exon 20 insertion mutation confirmed by an approved local laboratory. 5. No disease progression in the past two weeks of signing the willing to sign a consent form form and a score of 0-1 according to the ECOG criteria, and no significant progression within 2 weeks before the first dose. 6. At least one measurable target lesion according to RECIST v1.1. 7. Adequate bone marrow and other organ reserve: - Absolute neutrophil count (ANC) ≥ 1.5 × 109/L - platelet count at least 100 × 109/L - blood count (hemoglobin) at least 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 8. 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. 9. 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 Should NOT Join This Trial: 1. Patients who have received the following treatments must be excluded: - Any systemic anti-tumor treatment, including radiotherapy; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Patients must understand the requirements and content of the clinical trial and provide a handwritten signed and dated informed consent. 2. Age ≥ 18 years old. 3. 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. 4. EGFR exon 20 insertion mutation confirmed by an approved local laboratory. 5. 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. 6. At least one measurable target lesion according to RECIST v1.1. 7. 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 8. 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. 9. 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. Exclusion Criteria: 1. 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. 2. 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). 3. 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.). 4. History of stroke or intracranial hemorrhage within 6 months before the first dose. 5. 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 6. 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. 7. Patients with refractory nausea and vomiting, chronic gastrointestinal diseases, difficulty in swallowing medication, or previous intestinal resection that prevents adequate absorption of sunvozertinib. 8. Women who are breastfeeding or pregnant. 9. Patients who are allergic to the drug components of sunvozertinib. 10. 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.

Treatments Being Tested

DRUG

Sunvozertinib

Neoadjuvant stage: 300mg for 12 weeks Adjuvant stage: 300mg for first 4 weeks, then 150mg for up to 2 years

Locations (3)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Second Xiangya Hospital of Central South University
Changsha, Hunan, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Tangdu Hospital
Xi'an, Shaanxi, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06864624), the sponsor (Tang-Du Hospital), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06864624 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06864624?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06864624?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06864624. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06864624. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.