New pill could keep lung cancer away after surgery
NCT ID NCT07182682
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a daily pill called sunvozertinib against a placebo in 360 people with a specific type of lung cancer (stage IB-IIIA) who have had surgery to remove their tumor. The goal is to see if the drug can stop the cancer from returning. Participants must have certain EGFR gene changes and will be followed for several years.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 360 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Jan 2031
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Provide a signed and dated informed consent form (ICF) prior to any study specific procedures, sampling, and analyses. 2. Aged at least 18 years old at the time of ICF signature. 3. 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. 4. Participants must have NSCLC classified post-operatively as stage IB, II, or IIIA according to the AJCC TNM staging 9.0th edition. 5. 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. 6. Participants must provide sufficient tumor tissue samples for confirmation of EGFR mutations by the sponsor designated central laboratory. 7. ECOG performance status is 0 or 1. 8. 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. 9. Adequate bone marrow reservation or organ functions within 7 days prior to randomization. 10. 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. 11. 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. Exclusion Criteria: 1. Concurrent EGFR sensitizing mutations (L858R and/or exon 19 deletion) or other driver gene variations with available standard therapies (e.g., ALK positive). 2. Participants who have had only segmentectomies or wedge resections. 3. Participants who have received any preoperative or postoperative radiotherapy for NSCLC, or who plan to have radiotherapy during the study. 4. Participants who have received any EGFR TKIs as (neo)adjuvant therapy for NSCLC or have known pathological complete response from previous neoadjuvant therapy. 5. Participants who are receiving (or unable to stop) medications or herbs known to be strong CYP3A inducers within 2 weeks prior to randomization. 6. 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. 7. 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). 8. 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. 9. 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 10. 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. 11. Hypersensitivity to sunvozertinib, excipients of sunvozertinib, or drugs of similar chemical structure or same class. 12. Involvement in the design, planning or conduct of this study (applicable to Dizal staff or study site staff). 13. Judgment by the investigator that the participant is unlikely to comply with study procedures, restrictions or requirements.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
49 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Affiliated Cancer Hospital and Institute of Guangzhou Medical University
NOT_YET_RECRUITINGGuangzhou, China
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Anhui Provincial Cancer Hospital
RECRUITINGHefei, China
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Beijing Cancer Hospital
NOT_YET_RECRUITINGBeijing, China
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Beijing Chest Hospital, Capital medical university
NOT_YET_RECRUITINGBeijing, China
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Cancer Hospital Chinese Academy of Medical Sciences
NOT_YET_RECRUITINGBeijing, China
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China-Japan Friendship hospital
NOT_YET_RECRUITINGBeijing, China
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Fudan University Shanghai Cancer Center
NOT_YET_RECRUITINGShanghai, China
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Fujian Cancer Hospital
NOT_YET_RECRUITINGFuzhou, China
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Fujian Medical University Union Hospital
NOT_YET_RECRUITINGFuzhou, China
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Guangxi Medical University Cancer Hospital
NOT_YET_RECRUITINGNanning, China
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Harbin Medical University Cancer Hospital
NOT_YET_RECRUITINGHarbin, China
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Henan Cancer Hospital
NOT_YET_RECRUITINGZhengzhou, China
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Hubei Cancer Hospital
NOT_YET_RECRUITINGWuhan, China
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Hunan Cancer Hospital
NOT_YET_RECRUITINGChangsha, China
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Jiangsu Province Hospital
NOT_YET_RECRUITINGNanjing, China
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Jiangxi Provincial People 's Hospital
NOT_YET_RECRUITINGNanchang, China
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Jinan Central Hospital
NOT_YET_RECRUITINGJinan, China
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Liaoning Cancer Hospital & Institute
NOT_YET_RECRUITINGShenyang, China
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Nanjing Chest Hospital
NOT_YET_RECRUITINGNanjing, China
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Peking Union Medical College Hospital
NOT_YET_RECRUITINGBeijing, China
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Shandong Cancer Hospital
RECRUITINGJinan, China
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Shanghai Chest Hospital
NOT_YET_RECRUITINGShanghai, China
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Shanghai East Hospital
NOT_YET_RECRUITINGShanghai, China
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Shanghai Pulmonary Hospital
RECRUITINGShanghai, China
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Shanxi Cancer hospital (Shanxi Cancer institute)
NOT_YET_RECRUITINGTaiyuan, China
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Shanxi Provincial people's hospital
NOT_YET_RECRUITINGTaiyuan, China
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Sichuan Cancer Hospital
NOT_YET_RECRUITINGChengdu, China
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Sun Yat-sen Memorial Hospital, Sun Yat-sen University
NOT_YET_RECRUITINGGuangzhou, China
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Sun Yat-sen University Cancer Center
NOT_YET_RECRUITINGGuangzhou, China
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Taizhou Hospital, Zhejiang Province
NOT_YET_RECRUITINGTaizhou, China
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The Affiliated Hospital of Xuzhou Medical University
NOT_YET_RECRUITINGXuzhou, China
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The First Affiliated Hospital Zhejiang University School of Medicine
NOT_YET_RECRUITINGHangzhou, China
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The First Affiliated Hospital of Guangzhou Medical University
NOT_YET_RECRUITINGGuangzhou, China
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The First Affiliated Hospital of Xi'an Jiaotong University
NOT_YET_RECRUITINGXi'an, China
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The First Hospital of China Medical University
NOT_YET_RECRUITINGShenyang, China
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The First Hospital of Jilin University
RECRUITINGChangchun, China
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The Second Affiliated Hospital Zhejiang University School of Medicine
NOT_YET_RECRUITINGHangzhou, China
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The Third Xiangya Hospital of Central South University
NOT_YET_RECRUITINGChangsha, China
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The first affiliated hospital of Zhengzhou University
NOT_YET_RECRUITINGZhengzhou, China
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Tianjin Chest Hospital
NOT_YET_RECRUITINGTianjin, China
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Tianjin Medical University Cancer Institute & Hospital
NOT_YET_RECRUITINGTianjin, China
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Tianjin Medical University General Hospital
NOT_YET_RECRUITINGTianjin, China
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
NOT_YET_RECRUITINGWuhan, China
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West China Hospital Sichuan University
NOT_YET_RECRUITINGChengdu, China
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Xiangya Hospital of Central South University
NOT_YET_RECRUITINGChangsha, China
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Xuanwu Hospital Capital Medical University
NOT_YET_RECRUITINGBeijing, China
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Yunnan Cancer Hospital
NOT_YET_RECRUITINGKunming, China
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Zhejiang Cancer Hospital
NOT_YET_RECRUITINGHangzhou, China
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Zhongshan Hospital Fudan University
NOT_YET_RECRUITINGShanghai, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new drug shrink advanced solid tumors?
- Can a targeted drug delivery system shrink lung tumors?
- Can a new drug shrink tumors that resist standard care?
- Can a Three-Dose immunotherapy cure early lung cancer without surgery?
- Can a new drug shrink advanced solid tumors?
- Can a less extensive lung cancer surgery be just as effective?