Non-Small Cell Lung Cancer
Conditions
Interventions
Experimental Group:Almonertinib + platinum-based chemotherapy + local treatment (surgery combined with radiotherapy or radiotherapy alone)
Sponsors
Liaoning Cancer Hospital & Institute
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age above 18 years old (including 18 years old); 2. The Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1, and no deterioration in the first 2 weeks of treatment, and the expected survival time is not less than 12 weeks; 3. Histological or cytological confirmation of NSCLC, T1-4N3M0 (AJCC 9th); Systemic 18F-fluorodeoxyglucose positron emission tomography (PET) or contrast-enhanced computed tomography (CT) or PET-CT suspicious lymph nodes should undergo invasive lymph node staging, which can be confirmed by endobronchial ultrasound, mediastinoscopy, thoracoscopy, or needle biopsy; However, when the lymph nodes of mediastinal region 5 and 6 were highly suspicious, they were not forced; 4. Did not receive any systemic or local treatment after diagnosis of NSCLC; 5. Known EGFR-sensitive mutations (including exon 19 deletion or 21 L858R, both alone or co-existing or accompanied by other EGFR site mutations, with primary T790M mutation can be included, with exon 20 insertion mutation can not be included, blood/cytology/histology approved); 6. The patient had at least one tumor lesion that was measurable at baseline according to RECIST 1.1 criteria. Maximum diameter =10 mm at baseline (minimum diameter =15 mm in case of lymph nodes). The measurement method chosen is suitable for accurate repeat measurements and can be a CT or magnetic resonance scan (MRI). If only one measurable lesion is present, it can be accepted as a target lesion, and baseline evaluation of the tumor lesion should be performed at least 14 days after the diagnostic biopsy. Baseline imaging assessment of the tumor was performed within 28 days prior to the first dose. 7. Women of childbearing age should use appropriate contraception and should not breastfeed for 3 months from screening to discontinuation of study treatment. Prior to initiation of the drug, the pregnancy test was negative, or one of the following criteria was met to demonstrate that there was no pregnancy risk: ? Postmenopause was defined as age greater than 50 years and amenorrhea for at least 12 months after discontinuation of all exogenous hormone replacement therapy; (2) Women younger than 50 years of age may also be considered postmenopausal if they have stopped all exogenous hormone therapy for 12 months or more and their luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels are within the laboratory postmenopausal reference range; Have undergone irreversible sterilization, including hysterectomy, bilateral ovariectomy, or bilateral tubal resection, except bilateral tubal ligation; 8. Male patients should use barrier contraception (i.e., condoms) for 3 months from screening to discontinuation of study treatment; 9. The participant must voluntarily agree to participate and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of superior lung sulcus tumor; 2. Primary tumor or metastatic lymph nodes surround or infiltrate aorta/trachea/esophagus/heart, etc. 3. Have received any of the following treatment: ? Have previously undergone lung surgery; ? Previous use of any EGFR tyrosine kinase inhibitors; (3) Prior acceptance of any antitumor therapy such as systemic chemotherapy or immunotherapy for lung cancer; (4) Receiving any previous radiotherapy for lung cancer; Had undergone major surgery within 14 days prior to use of the study drug; Or have undergone major surgery within 28 days and have not fully recovered from the toxicity and/or complications of the intervention; (6) Patients who had used proprietary Chinese medicines with anti-tumor effects for no more than 7 days, and had stopped taking the drugs for 2 weeks or more before the drug treatment in this study could be enrolled; 4. In addition to NSCLC, have been diagnosed with another malignant disease within the last 5 years (excluding completely resected basal cell or squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, or breast carcinoma in situ); 5. People who have had a major gastrectomy in the past, and who have swallowing dysfunction, active gastrointestinal disease, or other diseases that significantly affect the absorption, distribution, metabolism, and excretion of oral drugs; 6. Fever with a body temperature above 38 ° C within the last 1 week, or clinically significant active infections, active tuberculosis, and active fungal, bacterial, and/or viral infections requiring systemic treatment [Allow patients with chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection to receive antiviral therapy]; 7. Patients with active bleeding or new thrombotic diseases who are taking therapeutic amounts of anticoagulant drugs or have bleeding tendencies; 8. Meet any of the following cardiac test results: (1) Corrected QT interval (QTc) from resting electrocardiogram (ECG) examination > 470 msec; The resting ECG indicates a variety of clinically significant rhythms, conduction or ECG morphological abnormalities (e.g., clinically significant ventricular arrhythmia or atrial fibrillation, complete left bundle branch block, 3rd degree atrioventricular block, 2nd degree atrioventricular block, and PR interval > 250 msec); ? Unstable angina pectoris, myocardial infarction, coronary/peripheral artery bypass, or cerebrovascular accident occurred within 3 months; (4) There are risk factors leading to prolonged QT interval or increased risk factors for arrhythmia, such as heart failure, =CTCAE (4.03 version), 2 degrees hypokalemia (blood potassium <3.0mmol/L, and symptoms, need treatment), congenital long QT syndrome, long QT syndrome family history; Or sudden unexplained death of an immediate family member under the age of 40; Or being on any drug known to prolong the QT interval within 2 weeks prior to initial dosing; Congestive heart failure, New York Heart Association (NYHA) grade = 2 chronic heart failure; Left ventricular ejection fraction (LVEF) =40%; 9. Evidence of uncontrolled hypertension (i.e., hypertension greater than or equal to CTCAE level 3 after medication); 10. The presence of severe or uncontrolled systemic disease, unstable or uncompensable respiratory, liver or kidney disease; 11. A history of interstitial lung disease or clinically active interstitial lung disease, lung inflammation (non-infectious) or poorly controlled lung disease (incl
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Local recurrence rate;Distant metastasis rate;Safety;Quality of life;Patient-reported outcomes;ORR;DCR;DPR;Clinical down-staging rate;R0 rate;Pathologic complete remission rate in the surgical area;MPR rate;Mediastinal Nodal Clearance rate; | — |
Countries
China
Contacts
Public ContactHongxu Liu
Liaoning Cancer Hospital & Institute
Outcome results
None listed