EGFR+ Non small cell lung cancer
Conditions
Interventions
Treatment group:160mg/d Furmonertinib and Cisplatin/Pemetrexed
Sponsors
Army Medical Center of PLA
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. With written informed consent before any study procedure; 2. Male or female, age 18-75; 3. Histology or cytology diagnose of non-small cell lung cancer within 60 days; 4. According to the eighth edition of AJCC lung cancer staging, for patients in stage II-IIIB (N1-N2, where N1 is determined by imaging, and N2 is confirmed by thoracoscopy, EBUS-TBNA or PET/CT), who have undergone systematic imaging evaluations (including enhanced chest/abdominal CT, enhanced head CT/MRI, radionuclide bone scan, or whole-body PET/CT examination), and whose lesions have not invaded the surrounding adjacent structures or organs (such as main bronchus, parietal pleura, chest wall, phrenic nerve, heart, major blood vessels, recurrent laryngeal nerve, carina, esophagus, vertebral body, etc., and there are no independent tumor nodules in different ipsilateral lung lobes), and who are planned for radical resection, the lesions are treated with surgical methods such as lobectomy, sleeve resection, bilateral lobectomy or pneumonectomy (either minimally invasive or open surgical procedures are acceptable); 5. The EGFR mutation was positive (19Del and/or L858R mutation, with or without T790M mutation) as indicated by NGS testing of tumor tissues or blood; 6. There is at least one measurable lesion, with the longest diameter of = 10 mm as shown in the baseline CT scan (except for lymph nodes which must have a short axis of = 15 mm), and it is suitable for accurate repeated measurement; 7. ECOG performance status 0-1; 8. Female patients should take adequate and effective contraceptive measures, refrain from breastfeeding, and have a negative pregnancy test before the first administration of the study drug; or female patients must meet the following criteria at screening to prove their infertility: a. Postmenopausal, defined as being over 50 years old and having no menstruation for at least 12 months after discontinuing all exogenous hormone treatments. b. For women under 50 years old, if they have no menstruation for 12 months or longer after discontinuing exogenous hormone treatments, and their luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels are within the postmenopausal range, they are considered postmenopausal. c. Documented irreversible sterilization procedures, including hysterectomy, bilateral oophorectomy or bilateral salpingectomy, but not tubal ligation. 9. Male patients should be willing to adopt barrier contraception(condoms).
Exclusion criteria
Exclusion criteria: 1. Squamous cell carcinoma, and tumors with neuroendocrine components such as large cell carcinoma, or small cell carcinoma; 2. Patients with EGFR exon 20 insertion mutation; 3. Exposure to other antitumor therapies prior to enrolment; 4. Major surgery was performed in the four weeks prior to the first dosing of the study drug; 5. Pregnant or lactating female patients; 6. Within 7 days prior to the first administration, the patient had used a CYP3A4 strong inhibitor; within 21 days prior to the first administration, the patient had used a CYP3A4 strong inducer; within 14 days prior to the first administration, the patient had used traditional Chinese medicine or its preparations with anti-tumor indications, traditional Chinese medicine or its preparations with tumor-assisted therapeutic effects, and other drugs with anti-tumor activity; 7. Have a history of other malignant tumors, or currently have another malignant tumor (excluding those that have undergone radical surgery and have not recurred within 5 years after the surgery, such as cervical carcinoma in situ, skin basal cell carcinoma, and papillary thyroid carcinoma, etc.); 8. Patients with severe or uncontrolled systemic diseases requiring treatment, and those considered unsuitable for the trial by the researchers, include those with hypertension, diabetes, chronic heart failure (NYHA cardiac function classification III-IV), unstable angina pectoris, myocardial infarction within the past year, active bleeding, etc.; hepatitis B (including all HBsAg-positive patients), hepatitis C (HCV Ab positive) and human immunodeficiency virus (HIV); patients with active infections requiring intravenous medication treatment; 9. Severe gastrointestinal dysfunction, which may affect the intake, transport or absorption of the investigational drug, such as inability to take oral medication, uncontrollable nausea and vomiting, extensive history of gastrointestinal resection, etc; 10. Meet any of the following criteria for cardiac assessment: a. The corrected QT interval (QTc) on resting ECG is greater than 470 milliseconds, and the QTc is corrected using the F formula (if the initial ECG measures a QTc greater than 470 milliseconds, repeat the ECG measurement twice and take the average of the three QTc results). b. Any clinically significant abnormality in the rhythm, conduction, or morphology of the resting ECG, such as complete left bundle branch block, second or third degree atrioventricular block, etc. c. Any factor that increases the risk of QTc prolongation or arrhythmia events, such as heart failure, hypokalemia, congenital long QT syndrome, long QT syndrome family history, or sudden death in a first-degree relative under 40 years old of unknown cause, or a person who is not able to discontinue any concomitant medication that is known to prolong the QT interval. 11. Patients who have a history of interstitial lung disease (ILD), drug-induced interstitial lung disease, radiation pneumonitis requiring glucocorticoid treatment, or have clinical manifestations suggestive of interstitial lung disease; 12. Any of the following laboratory tests indicate insufficient bone marrow or organ reserve function. a) Absolute neutrophil count 2.5 × upper limit of normal (ULN) e) Aspartate transaminase (AST) > 2.5 × ULN f) Total bilirubin > 1.5 × ULN or with Gilbert syndrome (non-conjugated hyperbilirubinemi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major pathologic response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence rate of adverse events;Disease control rate;overall survival;disease free survival;Pathological complete response rate;Objective Response Rate; | — |
Countries
China
Contacts
Public ContactLi Li
Army Medical Center of PLA
Outcome results
None listed