Previously untreated EGFR-sensitive mutation-mutated metastatic (TNM stage IV) non-small cell lung cancer
Conditions
Interventions
Group A (brain metastases control group):75-100 mg QD
Group B (Brain Metastasis Experimental Group):25mg TID
Group C (Meningeal metastasis observation group):75-100 mg QD
Sponsors
Henan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign a written informed consent form, able to understand and comply with the requirements of the trial protocol. 2. The age at the time of signing the informed consent form is >= 18 years old. 3. Metastatic non-small cell lung adenocarcinoma confirmed by histology or cytology (AJCC 8th edition stage IV), and not suitable for radical surgery or radiotherapy. A mixed histological type dominated by adenocarcinoma components is acceptable. Simultaneously accompanied by brain (membrane) metastasis. For patients with meningeal metastases (LM), positive cerebrospinal fluid cytology tests or positive cerebrospinal fluid EGFR mutations are required. The tissue for examination cannot come from tumor lesions that have been treated with radiation, and newly developed lesions after local treatment can be used. 4. Have not previously received systemic antitumor therapy for metastatic NSCLC with EGFR-sensitive mutations (exon 19 deletion or exon 21 L858R mutation, both alone or co-existing with other EGFR site mutations). Patients who have received local treatment for more than 2 weeks may participate in the study if the lesions within the local treatment range are non-target lesions. Remarks: Subjects who have previously completed radical surgery and adjuvant therapy for early stage NSCLC but later develop disease recurrence or metastasis can also be enrolled, provided that the interval between the end of adjuvant therapy and the first dosing of this study is more than 6 months. Participants who had previously used EGFR-TKIs as adjuvant therapy could not be enrolled. 5. ECOG score =10mm, and the short diameter of lymph node lesions was >=15mm. 8. There must be at least one measurable intracranial lesion that is asymptomatic, untreated, and does not require local treatment at enrollment; Measurable intracranial lesions were defined as brain metastases that could be accurately measured with magnetic resonance imaging (MRI) of =5mm in at least one dimension (the longest diameter to be recorded). If the lesion is 5-10mm in size and is the only measurable disease, MRI imaging must be performed using sections of 1.5mm or less. 9. Voluntary consent to the use of regular and effective contraception throughout the study period and for 3 months after the final dose [For women: 1. Oral, injectable or hormonal contraceptive methods; 2. Intrauterine devices or intrauterine birth control systems; 3. Barrier contraception: spermicidal condoms or blocking caps (diaphragm or cervical/fornix caps). For men: (1) Condoms with spermicidal effect; (2) surgical sterilization (such as: bilateral testicles, bilateral vasectomy); Premenopausal fertility is possible (premenopausal fertility is possible if the following conditions are met: 1. Bilateral tubal ligation, hysterectomy, and bilateral ovariectomy were not performed. 2. Fem
Exclusion criteria
Exclusion criteria: 1. Associated with other malignancies (except clinically cured cervical carcinoma in situ, basal cell or squamous cell skin cancer, and thyroid papillary carcinoma). 2. Patients with meningeal metastases (LM) cannot be examined with enhanced MRI. 3. Patients who experience complications of the central nervous system (CNS) and require emergency neurosurgical treatment (such as surgery); Patients with brain metastases who need to use an equivalent dose of dexamethasone exceeding 10mg per day for the first 5 days prior to medication to control symptoms. 4. NSCLC was previously treated with any EGFR TKI drug. 5. Previous use of any systemic antitumor therapy for locally advanced or metastatic NSCLC, including systemic chemotherapy, immunotherapy, biotherapy, etc. 6. Within 2 weeks prior to the treatment of the investigational drug, they had received traditional Chinese medicine and proprietary Chinese medicine preparations for anti-tumor indications. 7. Patients who had surgery within 4 weeks prior to study drug treatment, except for minor surgery (e.g., tooth extraction, etc.) that the investigators determined would not affect participation in the trial; Or those who plan to undergo major surgery during the study period. 8. If symptoms or signs deteriorated significantly within 2 weeks prior to screening (for example, a large amount of pleural effusion was found within 2 weeks prior to screening, screening could be considered after control of pleural effusion), the investigator judged that it was not suitable for participation in the experiment; 9. Any clinical evidence of a severe or uncontrolled disease that the investigator considers ineligible to participate in the clinical trial or that would affect the patient's adherence to the study protocol, Examples include patients with uncontrolled hypertension (SBP>160mmHg or DBP>100mmHg), active bleeding prone patients, active infection patients (such as hepatitis B, hepatitis C, syphilis, HIV antibody positive) after drug treatment. Active hepatitis B is defined as HBV DNA >= 2000 IU/ml (equivalent to 10^4 copies /ml); Active hepatitis C is defined as HCV RNA above the lower limit of detection. 10. In the resting state, for those with abnormal QTcF results corrected by the screening period electrocardiogram, two retests with an interval of more than 4 hours each time are required. The average QTcF of the three electrocardiogram examinations is >= 450 msec for males and >= 470 msec for females. Various clinically significant abnormalities in heart rhythm, conduction, and resting ECG morphology, such as complete left bundle branch block, third degree block, second degree block, PR interval>250 msec. There are factors that increase the risk of QTc prolongation or arrhythmia events, such as heart failure, hypokalemia, congenital long QT syndrome, first-degree relatives with long QT syndrome in family history, or unexplained sudden death before the age of 40, known as concomitant medication for prolonging QT interval. Echocardiography examination shows left ventricular ejection fraction (LVEF) <= 50% or other clinically significant abnormalities determined by the researcher. 11. A history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonia requiring hormone therapy, or clinical evidence of active interstitial lung disease. 12. Any condition that affects the patient's ability to swallow or absorb drugs orally, such as severe chronic gastrointestinal disease, g
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;Intracranial objective remission rate;Intracranial progression free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactWang Huijuan
Henan Cancer Hospital
Outcome results
None listed