New pill shrinks lung tumors before surgery in early trial
NCT ID NCT07274761
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a pill called sunvozertinib given before surgery to people with a certain type of lung cancer (stage II-IIIB non-small cell lung cancer with EGFR exon 20 insertion mutations). The goal is to see if the drug can shrink tumors and improve surgical outcomes. About 24 participants will receive the drug and be monitored for response and side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Oct 2024
- Expected to finish
-
May 2030
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
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\. The patient must understand the trial requirements and contents, and provide written informed consent. 2.Age ≥ 18 years. 3.Histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC). Assessed as resectable Stage II-III disease (per the American Joint Committee on Cancer (AJCC) 8th edition). 4.Confirmed EGFR exon 20 insertion mutation by a validated test. 5.No evidence of disease progression within the past two weeks prior to signing informed consent and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6.Adequate hematological and organ function, as defined by: 7.Hematological: Absolute Neutrophil Count (ANC) ≥ 1.5 × 10\^9/L Platelet count ≥ 100 × 10\^9/L Hemoglobin ≥ 9 g/dL Hepatic: Total bilirubin ≤ 1.5 × Upper Limit of Normal (ULN); for patients with Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases, total bilirubin ≤ 3 × ULN. Alanine Aminotransferase (ALT) ≤ 2.5 × ULN and Aspartate Aminotransferase (AST) ≤ 2.5 × ULN in the absence of liver metastases; or ALT and AST ≤ 5 × ULN for patients with liver metastases. Renal: Serum creatinine ≤ 1.5 × ULN, AND Calculated or measured creatinine clearance ≥ 60 mL/min (using the Cockcroft-Gault formula). 8.Male patients with female partners of childbearing potential must agree to use a highly effective barrier method of contraception (e.g., condom) during the trial intervention period and for 6 months after the last dose. Male patients must refrain from donating sperm during this same period. 9.Female patients must agree to use contraception from the time of screening until 6 weeks after the last dose, must not be breastfeeding, and must have a negative pregnancy test (serum or urine beta-human chorionic gonadotropin, β-hCG) at screening. Exclusion Criteria: * 1.Prior systemic anti-tumor therapy, including chemotherapy, targeted therapy, immunotherapy, and investigational agents from other clinical trials. 2.History of other malignancies within the past 2 years (except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix). 3.History of stroke or intracranial hemorrhage within 6 months prior to the first dose. 4.Severe or uncontrolled systemic diseases/active infection. 5.Any severe or poorly controlled systemic disease, in the investigator's judgment, including but not limited to the following cardiac conditions or abnormalities: QT interval corrected using Fridericia's formula (QTcF) \> 470 msec at rest on electrocardiogram (ECG). Any clinically significant abnormalities in cardiac rhythm, conduction, or morphology at rest on ECG, such as complete left bundle branch block, third-degree atrioventricular block, second-degree atrioventricular block, PR interval \> 250 msec. Any factors that increase the risk of QTc prolongation or arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death in a first-degree relative under 40 years of age, or any other known condition associated with prolonged QT interval. Presence of atrial fibrillation (except for drug-induced atrial fibrillation which has resolved after discontinuation of the causative agent). Myocardial infarction ≤ 6 months prior to the first dose, New York Heart Association (NYHA) Class II or higher congestive heart failure, or poorly controlled arrhythmia despite medical treatment. 6.History of interstitial lung disease (ILD), drug-induced ILD, or any evidence of ILD on imaging at screening. 7.Refractory nausea and vomiting, chronic gastrointestinal diseases, or significant bowel resection that would preclude adequate absorption of Sunvozertinib. 8.Women who are breastfeeding or pregnant. 9.Known hypersensitivity to the active ingredient or any excipients of Sunvozertinib. 10.Patients who, in the judgment of the investigator, are unsuitable for participation in this clinical trial or are unlikely to comply with the study procedures and requirements.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Non-small cell lung cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
Contacts and locations
Locations
-
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Surgeons could freeze lung tumors from miles away using 5G robots
- Two-Drug combo targets stubborn KRAS lung cancer
- Smaller chest drain may speed recovery after lung cancer surgery
- Gut bacteria may hold clues to why some cancer treatments work better
- Breath-Tracking sensor aims to sharpen lung cancer scans
- Can PET scan signals predict who beats lung cancer with immunotherapy?