Non-small cell lung cancer
Conditions
Interventions
Experimental group:Sunvozertinib
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age>=18 years old, gender is not limited; 2. Histologically confirmed primary NSCLC; 3. Computed tomography (CT) or magnetic resonance scan (MRI) of the brain should be performed before surgery; 4. Postoperative pathological confirmation of IB-IIIB (N1-N2) stage; 5. Tumor tissue samples or blood samples diagnosed with stage IB-IIIB NSCLC confirmed to have EGFR ex20ins mutations by laboratory testing; 6. Primary NSCLC needs to be completely resected and the margins are negative; 7. At the time of enrollment, the patient has completely recovered from surgery or postoperative adjuvant chemotherapy (if adjuvant chemotherapy is used); 8. WHO physical status score of 0~1; 9. Females of childbearing potential should take appropriate contraceptive measures from screening to 3 months after stopping study treatment and should not breastfeed. Before starting the dosing, the pregnancy test was negative; 10. Male patients should use barrier contraception (i.e., condoms) from screening until 3 months after discontinuation of study treatment; 11. The subject himself voluntarily participates and signs the informed consent form in writing.
Exclusion criteria
Exclusion criteria: 1. Received any of the following treatments: arbitrary immuno-anti-tumor therapy; b. Preoperative or postoperative or planned radiotherapy; c. Neoadjuvant therapy with platinum-based or other chemotherapy preoperatively; d. Prior treatment with any EGFR tyrosine kinase inhibitor; e. Patient has undergone major surgery within 4 weeks prior to the first dose; f. Receipt of other investigational drugs within 5 half-lives g. Use of strong inhibitors of CYP3A4, inducers, or drugs with a narrow therapeutic window as CYP3A4-sensitive substrates within 7 days prior to the first dose of study drug. 2. Patients who have undergone wedgectomy only. 3. Have a history of other malignant tumors, except for non-melanoma skin cancer, carcinoma in situ or other solid tumors that have been effectively treated, and there is no evidence of any disease > 5 years after the last treatment. 4. At the time of initiation of study treatment, there are residual toxicities from previous treatment that are greater than CTCAE grade 1 that have not been relieved, except for those with alopecia and grade 2 neurotoxicity caused by previous chemotherapy. 5. Any severe or uncontrolled systemic disease, including uncontrolled hypertension and active bleeding patients, which in the opinion of the investigator is not suitable for participation in the study or affects compliance with the trial protocol, or has active infection including hepatitis B, C, HIV. 6. Refractory nausea, vomiting or chronic gastrointestinal disease, unable to swallow the study drug or having undergone extensive bowel resection that may affect adequate absorption of suvotinib. 7. Consistent with any of the following cardiac examination results: a. Mean corrected QT interval (QTc>) of 470 msec obtained by 3 electrocardiograms (ECG) examinations at rest, QT interval correction (QTcF) using Fridericia's formula; b. Resting ECG suggests the presence of a variety of clinically significant rhythmic, conduction, or ECG morphological abnormalities (e.g., complete left bundle branch block, third-degree atrioventricular block, second-degree atrioventricular block, and PR interval >). 250 msec); c. Presence of any factor that increases 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 an immediate family member under 40 years of age, or any concomitant medication that prolongs the QT interval; 8. Has a history of interstitial lung disease, a history of drug-induced interstitial lung disease, a history of radiation pneumonitis requiring steroid therapy, or any evidence of clinically active interstitial lung disease. 9. Insufficient bone marrow reserve or organ function. 10. Allergy to suvotinib components. 11. Patients who, in the judgment of the investigator, may have poor compliance with the procedures and requirements of the study. 12. Patients with any condition that jeopardizes patient safety or interferes with study evaluations as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year DFS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| DFS rates for 2, 4 and 5 years;2-, 3-, 4- and 5-year overall survival (OS) rates;Median DFS; | — |
Countries
China
Contacts
Public ContactChang Chen
Shanghai Pulmonary Hospital
Outcome results
None listed