Non-small cell lung cancer
Conditions
Interventions
Experimental group:After three cycles of treatment with aumolertinib combined with pemetrexed + carboplatin, treatment efficacy will be assessed.
Aumolertinib is administered at 110 mg orally once da
pemetrexed at 500 mg/m2, and carboplatin at an area under the curve (AUC) of 4–5. The specific chemotherapy doses may be adjusted by the investigator based on individual patient conditions.
Subsequen
for those deemed non-resectable, definitive radiotherapy will be administered. If radiotherapy is selected during the local treatment phase, the decision to concurrent with targeted therapy or chemoth
surgery is recommended 4–6 weeks after completion of the third chemotherapy cycle, with aumolertinib discontinued for 2 weeks prior to surgery.
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age should be above 18 years (inclusive of 18 years) and below 75 years (inclusive of 75 years). 2. Eastern Cooperative Oncology Group (ECOG) performance status score should be 0 or 1, and there should be no deterioration within 2 weeks before the treatment with the study drug. The expected survival period should be no less than 12 weeks. 3. Pathological histology or cytology confirmed, and judged by multidisciplinary team (MDT) as potentially resectable stage III (IIIA or IIIB) non-squamous cell non-small cell lung cancer (International Association for the Study of Lung Cancer 8th edition lung cancer staging). 4. Tumor tissue samples or blood samples should be confirmed as EGFR sensitive mutations by the researcher-approved laboratory tests (i.e., exon 19 deletion or L858R, either alone or coexisting, or accompanied by other EGFR site mutations, but patients with EGFR20 exon insertion mutation cannot be enrolled). 5. According to RECIST1.1 standard, the subjects must have at least one measurable lesion on imaging. The baseline imaging assessment should be conducted within 28 days before the first administration of the drug. 6. Pregnant women from the screening to the end of the study treatment should take appropriate contraceptive measures and should not breastfeed. Before starting the medication, the pregnancy test should be negative, or one of the following criteria should be met to prove no pregnancy risk: a. Postmenopausal defined as an age greater than 50 years and amenorrhea for at least 12 months after stopping all exogenous hormone replacement therapy. b. Women younger than 50 years old, if amenorrhea occurs after stopping all exogenous hormone therapy for 12 months or more, and the levels of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) are within the laboratory reference range for postmenopause, can also be considered postmenopausal. c. Male subjects from screening to the end of the study treatment should use barrier contraception, namely condoms. 7. Male subjects from screening to the end of the study treatment should use barrier contraception, namely condoms. 8. The subjects should voluntarily participate and sign the informed consent form in person.
Exclusion criteria
Exclusion criteria: 1. Have received any of the following treatments: a. Previously underwent lung surgery; b. Previously used any EGFR tyrosine kinase inhibitor; c. Previously received any systemic chemotherapy or immunotherapy for lung cancer; d. Previously received any radiotherapy for lung cancer; 2. Within 14 days before the patient used the study drug, had undergone open surgical procedures in any part other than the lungs (= 2 chronic heart failure. 9. Have experienced myocardial infarction, coronary artery/peripheral artery bypass or cerebrovascular accident within 3 months. 10. QT interval (QTc) in 12-lead electrocardiogram for males >= 450 ms, for females >= 470 ms. 11. Have risk factors causing QT interval prolongation or increasing the risk of arrhythmia, such as heart failure, = CTCAE (version 4.03) grade 2 hypokalemia (grade 2 hypokalemia is defined as: serum potassium 3 times the upper limit of normal (ULN); e. Aspartate aminotransferase > 3 × ULN; f. Total bilirubin > 1.5 × ULN; g. Creatinine > 1.5 × ULN or creatinine clearance rate < 45 mL/min (calculated by Cockcroft-Gault formula); h. Serum albumin (ALB) < 28
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological response ;Complete pathological remission;Overall survival period;Event-free survival period; | — |
Countries
China
Contacts
Public ContactLi Xin;Zhang Zhixuan
Sichuan Cancer Hospital
Outcome results
None listed