EGFR Exon 21 L858R-Mutated Advanced Lung Adenocarcinoma
Conditions
Interventions
experimental group:Almonertinib 165mg, oral, once daily (QD)
Sponsors
The Affiliated Panyu Central Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Aged between 18 and 80 years old at the time of signing the informed consent form, both males and females are eligible; 2.No prior anti-tumor medical treatment has been received; 3.Histologically or cytologically confirmed locally advanced or metastatic LUAD (including recurrent or newly diagnosed stage IIIB-IV patients after previous surgical treatment. According to the 9th edition of the AJCC lung cancer TNM staging criteria); 4.The presence of EGFR exon 21 L858R mutation confirmed by genetic testing on tumor tissue or blood samples before entering the trial, and the test results are recognized by all qualified testing institutions. 5.According to RECIST 1.1 criteria, subjects must have at least one measurable lesion (lesions that have received radiotherapy must show clear progression to be considered measurable). 6.ECOG PS score: 0-1. 7.Life expectancy >= 3 months. 8.Patients must have at least one lesion that has not been previously treated with radiation or other local therapies and can be accurately measured at baseline, with the longest diameter >=10 mm (for lymph nodes, the short axis must be >=15 mm). The chosen method of measurement should be suitable for accurate and repeatable measurements, which can be computed tomography (CT) or magnetic resonance imaging (MRI). If there is only one measurable lesion and it has not been previously treated with radiation or other local therapies, it may be accepted as the target lesion. 9.Non-surgically sterilized or women of childbearing age must undergo a serum pregnancy test within one week before the first dose of medication, with a negative result; they must not be in the lactation period. Women of childbearing age or men whose partners are of childbearing age must agree to use effective contraception during the study and for 3 months after the last administration of the study medication. 10.Patients voluntarily participate in this clinical study and sign the informed consent form, with good compliance and the ability to cooperate with follow-up visits.
Exclusion criteria
Exclusion criteria: 1.Histological diagnosis of squamous cell carcinoma or adenosquamous carcinoma, or positive expression of any marker (P63, P40, CK5/6) in immunohistochemical testing. 2.Prior receipt of any anti-tumor medication, including but not limited to EGFR-TKI, chemotherapy, immunotherapy. 3.Having received any of the following treatments: a. Major surgery within 4 weeks prior to the first dose of the study drug; b. More than 30% bone marrow radiation or extensive radiotherapy within 4 weeks prior to the first dose of the study drug; c. Use of strong CYP3A4 inhibitors, inducers, or narrow therapeutic window drugs that are substrates of CYP3A4 within 7 days prior to the first dose of the study drug. 4.Presence of symptomatic brain metastases, or meningeal metastases, spinal cord compression, etc. Patients who have undergone treatment for brain metastases (radiotherapy or surgery), have discontinued systemic corticosteroid therapy (prednisone >10mg/day or equivalent), and are asymptomatic may be included. 5.Presence of symptomatic, uncontrolled pleural effusion, pericardial effusion, or ascites. Patients who have undergone fluid drainage (excluding diagnostic thoracentesis), and have been stable for at least 2 weeks after drainage may be included (local treatment within the pleura according to routine clinical practice is allowed before giving informed consent). 6.History of other malignant tumors within 5 years or concurrently, excluding cured basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and in situ carcinoma of the breast. 7.History or presence of interstitial pneumonia/pulmonary fibrosis (except for radiological changes only), pneumonia requiring systemic corticosteroid treatment (such as radiation pneumonia, etc.). 8.Intractable nausea, vomiting, or chronic gastrointestinal disease, inability to swallow study medication, or having undergone extensive bowel resection, which may affect the adequate absorption of aumolertinib. 9.As judged by the investigator, any severe or poorly controlled systemic disease, such as poorly controlled hypertension, active bleeding tendency, or active infection. Chronic diseases do not need to be investigated. 10.Meeting any of the following cardiac examination results: a. The average corrected QT interval (QTc) from three ECG examinations in a resting state is >470 msec, corrected using the Fridericia formula (QTcF); b. Resting ECG showing clinically significant arrhythmias, conduction abnormalities, or ECG morphological abnormalities (e.g., complete left bundle branch block, third-degree atrioventricular block, second-degree atrioventricular block, and PR interval >250 msec); c. Presence of any factors that increase the risk of QTc prolongation or arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or any concomitant medication that prolongs the QT interval; d. Left ventricular ejection fraction (LVEF) <=40%. Major surgical treatment within 4 weeks prior to enrollment, local treatment within 2 weeks prior to enrollment, and failure to recover from previous intervention measures to <=grade 1 NCI-CTCAE (except for alopecia and fatigue). 11.Subjects who have had a serious infection within 1 month prior to enrollment, including but not limited to infectious complications requiring hospitalization, bacteremia, severe pneumonia, etc., or those who have used antibiotic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Intracranial Progression-Free Survival;overal survival;duration of remission;disease control rate;Safety and Tolerability; | — |
Countries
China
Contacts
Public ContactLin Liping
The Affiliated Panyu Central Hospital of Guangzhou Medical University
Outcome results
None listed