Lung Cancer
Conditions
Interventions
Experimental 1 group:firmonertinib 80mg, po, qd
Experimental 2 group:firmonertinib 80mg, po, qd or combined therapy
Sponsors
Tianjin Medical University General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Part 1: Radical resection of lung cancer was performed within the previous four weeks, and the surgical methods were lobectomy, sleeve resection, double lobectomy or total lung resection (minimally invasive or open surgery is acceptable, sublobectomy requires more than two groups of lymph node resection to confirm negative). Confirmed to be stage IA2-IB according to the AJCC 8th edition of lung cancer staging. And pathology confirmed the presence of high-risk factors such as histopathological high-risk (micropapillae, solid type, airspace spread, etc.), vascular invasion, pleural invasion (confirmed by elastic layer staining). Part 2: According to the AJCC 8th edition of lung cancer stage, stage IB-IIIB (N1-N2, N1 IS DETERMINED BY IMAGING, N2 is confirmed by thoracoscopy, EBUS-TBNA, or PET/CT) by systematic imaging evaluation (including enhanced chest/abdominal CT, enhanced cranial CT/MRI, isotope bone scan, or whole-body PET/CT) without invasion of surrounding adjacent structures or organs (eg, main bronchus, parietal pleura, chest wall, phrenic nerve, heart, large vessels, recurrent laryngeal nerve, carina, esophagus, pyramid, etc., and there is no independent tumor nodule in different ipsilateral lobes), lesions to be radically resected, and the surgical method is lobectomy, sleeve resection, double lobectomy or pneumonectomy (minimally invasive or open surgery is acceptable). Presence of at least 1 measurable lesion with a longest diameter of > = 10 mm on baseline CT (except for lymph nodes with a short axis > = 15 mm) and amenable to accurate repeat measurements. General Section: 1. Written informed consent has been obtained from the patient before carrying out any examination, sampling, and analysis related to the study; 2. Male or female, age 18-80 years old; 3. Primary lung adenocarcinoma confirmed by histology/cytology within 60 days prior to the study; 4. Positive for EGFR mutation (19Del and/or L858R mutation, with or without T790M mutation) by tumor tissue or blood NGS test; 5. ECOG performance status score of 0-1; 6. Female patients should take adequate and effective contraceptive measures, should not breastfeed, and have a negative pregnancy test before the first dose of the study drug; or female patients must meet the following criteria at screening to demonstrate non-childbearing potential: (1) Postmenopausal, defined as being older than 50 years old and without menstruation for at least 12 months after stopping all exogenous hormone therapy; (2) For women younger than 50 years of age, if there is no menstruation for 12 months or more after stopping exogenous hormone therapy, and the levels of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) are in the postmenopausal range, they are considered postmenopausal; (3) documented irreversible sterilization procedures, including hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, with the exception of tubal ligation; 9. Male patients should be willing to use barrier contraception, i.e. condoms.
Exclusion criteria
Exclusion criteria: 1. Tumors with neuroendocrine components such as squamous cell carcinoma, large cell carcinoma or small cell carcinoma; 2. Genetic detection of EGFR exon 20 insertion mutations; 3. Exposure to other anti-tumor therapies prior to enrollment; 4. Major surgery (including primary tumor surgery, excluding vascular access manipulation) within 4 weeks before the first dose of study drug; 5. Other medical procedures (such as endoscopy or paracentesis) or surgical procedures have been scheduled or planned to be scheduled in the next 4 months; 6. The patient is pregnant or lactating; 7. Use of strong inhibitors of CYP3A4 within 7 days or strong inducers of CYP3A4 within 21 days prior to the first dose; Within 14 days before the first dose, the use of traditional Chinese medicine and traditional Chinese medicine preparations with anti-tumor indications, traditional Chinese medicine and traditional Chinese medicine preparations with tumor adjuvant treatment effects, and other drugs with anti-tumor activity; 8. Have a history of other malignant tumors, or are now combined with other malignant tumors (except for malignant tumors that have undergone radical resection and have not recurred for 5 years after surgery, such as carcinoma in situ of the cervix, basal cell carcinoma of the skin and papillary thyroid carcinoma, etc.); 9. Patients with severe or uncontrolled systemic diseases requiring treatment, which are considered by the investigator to be unsuitable for participating in the trial, including hypertension, diabetes, chronic heart failure (NYHA cardiac function class III-IV), unstable angina, myocardial infarction within 1 year, active hemorrhagic and other diseases; hepatitis B (including all HBsAg-positive patients), hepatitis C (hepatitis C Ab-positive), and human immunodeficiency virus (HIV); Patients with active infection requiring intravenous therapy; 10. Severe gastrointestinal dysfunction, diseases or clinical states that may affect the intake, transport or absorption of study drugs, such as inability to take oral drugs, nausea and vomiting that are difficult to control, history of extensive gastrointestinal resection, etc.; 11. Meet any of the following cardiac evaluation criteria: (1) The QT interval (QTc) was corrected by resting ECG > 470 msec, and the QTc was corrected by the F formula (if the QTc was measured for the first time > 470ms, the ECG was retested twice, and the average of the results of the three QTc sessions was taken). (2) Any clinically important abnormalities in the rhythm, conduction or morphology of resting ECG, such as complete left bundle branch block, second- and third-degree atrioventricular block, etc.; (3) 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 of a first-degree relative under 40 years of age, or those who are taking any concomitant medication known to prolong the QT interval and cannot stop the drug; 12. Patients with a history of interstitial lung disease (ILD), drug-induced interstitial lung disease, radiation pneumonitis requiring glucocorticoid therapy, or patients with suspected clinical manifestations of interstitial lung disease; 13. Any of the following laboratory tests indicating inadequate function of bone marrow reserve or organ reserve; (1) Absolute neutrophil count< 1.5×10^9/L; (2) Platelet count< 100×10^9/L; (3) Hemoglobin <90
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression - Free Survival, PFS;Major Pathological Response rate MPR;Disease-Free Survival, DFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate, ORR;R0 resection rate; | — |
Countries
China
Contacts
Public ContactJun Chen
Tianjin Medical University General Hospital
Outcome results
None listed