Completely Resected Stage IA1–IA2 with High-risk Factors and Stage IA3 EGFR-Mutated NSCLC
Conditions
Interventions
Firmonertinib Group:Firmonertinib 80mg qd
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Histological or cytological examination suggests predominantly squamous-cell non-small cell lung cancer (NSCLC), or suggests small cell lung cancer, neuroendocrine carcinoma, sarcoma, etc.; 2. Subjects with other positive driver gene mutations (including ALK fusions, ROS1 fusions, BRAF V600E mutations, MET alterations, RET fusions, NTRK1/2/3 fusions, KRAS G12C mutations, HER2 mutations, NRG1 fusions, and FGFR alterations, but excluding mutations in TP53, RB1, BRCA, etc.); 3. Have received anti-tumour therapy, such as radiotherapy, chemotherapy, targeted therapy or immunotherapy, prior to surgery; 4. Are expected to require anti-tumour therapy other than that provided in this study during the trial period; 5. Have received any of the following treatments: a) Use of a strong CYP3A4 inhibitor within 7 days prior to the first dose, or use of a strong CYP3A4 inducer within 21 days prior to the first dose; b) Participation in and receipt of investigational drug or device clinical trials within 4 weeks prior to the first dose, or within at least 5 half-lives of the drug; c) Receipt of other anticancer drug therapy within 14 days prior to the first dose; 6. Post-operative recovery not yet reached 470 msec; or clinically significant QT prolongation; or other arrhythmias or clinical conditions deemed by the investigator to potentially increase the risk of QT prolongation (e.g. complete left bundle branch block, third-degree atrioventricular block, congenital long QT syndrome, severe hypokalaemia, or taking medications known to cause QT prolongation, etc.); 12. Severe gastrointestinal dysfunction that may affect the intake, transport or absorption of the study drug; 13. Infectious diseases requiring intravenous treatment; 14. Active infections, including hepatitis B, hepatitis C, HIV and syphilis: a) HBsAg-positive and HBV DNA >=1000 cps/ml (or 200 IU/ml); b) Anti-HCV antibody-positive and HCV RNA-positive; c) HIV antibody-positive; d) TP-positive; 15. Known history of psychiatric disorders or substance abuse, with active symptoms or current substance use; 16. Known or suspected hypersensitivity to voremetinib or any other component of the formulation; 17. Female subjects who are pregnant (confirmed by a positive pregnancy test) or breastfeeding; male subjects who are unwilling to use contraception during the trial; 18. Poor compliance, with the subject unable to adhere to the study procedures, restrictions or requirements; or any other circumstances deemed by the investigator to render the subject unsuitable for participation in this study.
Exclusion criteria
Exclusion criteria: 1. Histological or cytological examination suggests NSCLC with a predominance of squamous cells, or suggests small cell lung cancer, neuroendocrine carcinoma, sarcoma, etc.; 2. Subjects with other positive driver gene mutations (ALK fusion, ROS1 fusion, BRAF V600E mutation, MET mutation, RET fusion, NTRK1/2/3 fusion, KRAS G12C mutation, HER2 mutation, NRG1 fusion, FGFR mutation, but excluding TP53, RB1, BRCA, and other mutations); 3. Preoperative antitumor therapy, including radiotherapy, chemotherapy, targeted therapy, or immunotherapy; 4. Anticipated need for antitumor therapy other than that provided in this study during the trial period; 5. History of the following treatments: a) Use of a strong CYP3A4 inhibitor within 7 days or a strong CYP3A4 inducer within 21 days prior to the first dose; b) Participation in and receipt of investigational drug or device clinical trials within 4 weeks prior to the first dose or within at least 5 half-lives of the drug; c) Receipt of treatment with other anticancer drugs within 14 days prior to the first dose; 6. Postoperative recovery not yet reached = Grade 1 on the CTCAE (CTCAE 5.0) (excluding alopecia) or the level specified in the inclusion/exclusion criteria; 7. Patients with symptomatic and unstable pleural effusion; 8. History of other malignancies, or current concurrent malignancies; 9. History of interstitial lung disease (ILD), drug-induced interstitial lung disease, or radiation pneumonitis requiring steroid therapy; or patients with clinical manifestations suggestive of interstitial lung disease; 10. Patients with severe or uncontrolled systemic diseases requiring treatment, whom the investigator deems unsuitable for participation in the trial, including hypertension, diabetes, chronic heart failure (NYHA Class III–IV), unstable angina, myocardial infarction within the past year, active bleeding, and other such conditions; 11. Resting QT interval (QTc) > 470 msec as determined by clinical ECG screening; or clinically significant QT prolongation, or other arrhythmias or clinical conditions that the investigator believes may increase the risk of QT prolongation; such as complete left bundle branch block, third-degree atrioventricular block, congenital long QT syndrome, severe hypokalemia, or current use of medications known to prolong the QT interval; 12. Severe gastrointestinal dysfunction or conditions that may affect the intake, transport, or absorption of the study drug; 13. Patients with infectious diseases requiring intravenous medication; 14. Patients with active infections, including hepatitis B, hepatitis C, HIV, and syphilis: a) HBsAg-positive and HBV DNA >=1000 copies/mL (or 200 IU/mL); b) HCV antibody-positive and HCV RNA-positive; c) HIV antibody-positive; d) TP-positive; 15. Known history of psychiatric disorders or substance abuse, with current episodes or ongoing substance use; 16. Known or suspected hypersensitivity to voremetinib or any other component of the formulation; 17. Female subjects who are pregnant (confirmed by a positive pregnancy test) or breastfeeding; male subjects who are unwilling to use contraception during the study; 18. Poor compliance, unable to adhere to the study protocols, restrictions, or requirements; other circumstances deemed by the investigator to make the subject unsuitable for participation in this study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3?year DFS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events;1/2/5?year DFS rate;1/2/3/5?year OS rate;DFS; | — |
Countries
China
Contacts
Public ContactYingyi WANG
Peking Union Medical College Hospital
Outcome results
None listed