NSCLC
Conditions
Interventions
Experimental group:HSRT + TKI
Control group:TKI + HSRT
Sponsors
Shandong Cancer Hospital and Institute Affiliated to Shandong University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Non-small cell lung cancer diagnosed with EGFR mutation, 19 deletion mutation or L858R mutation; 2. KPS score 0-2; 3. Patients with or without symptoms of clinical brain metastases, lucid and able to tolerate radiotherapy; 4. No seizures or seizures after oral antiepileptic drugs control well; 5. No previous history of craniocerebral radiotherapy; 6. Agree to be randomly grouped and sign informed consent; 7. Multiple brain metastases were diagnosed: 3-10 brain metastases, maximum tumor diameter <= 2 cm, no meningeal metastases, excluding lesions of other nature; 8. Agree with intracranial metastases big stereotactic radiotherapy (Hypofractionated stereotactic radiotherapy, HSRT) 24 to 30 Gy/3, 1 day radiotherapy, radiotherapy is done in 1 week.
Exclusion criteria
Exclusion criteria: 1. Had received any of the following treatments: (1) Had undergone major surgery within 4 weeks prior to initial administration of the study drug; (2) Use of a CYP3A4 booster, inducer, or a drug with a narrow therapeutic window that is a CYP3A4 sensitive substrate within 7 days prior to initial drug administration; 2. At the beginning of the treatment study, there were unalleviated residual toxicity of previous treatment greater than CTCAE1, except for hair loss and grade 2 neurotoxicity caused by previous chemotherapy; 3. Any serious or poorly controlled systemic disease, as determined by the investigator, such as poorly controlled hypertension, an active bleeding prone constitution, or an active infection. You don't need to screen for chronic diseases; 4. Women who are breastfeeding or who have positive blood or urine pregnancy test results within 3 days before the first administration of the study treatment; 5. A history of hypersensitivity to any active or inactive component of ametinib or to drugs with a chemical structure similar to that of ametinib or the same class of ametinib; 6. Patients who are allergic to pemetrexed or any other component of the preparation, cisplatin or other platinum-containing compounds; 7. Patients with contraindications of cisplatin and pemetrexed; 8. Any severe or uncontrolled ocular lesions that the doctor determines may increase the safety risk of the patient; 9. Patients who are judged by the investigator to have poor compliance with the study procedures and requirements; 10. Patients with any condition that the investigator determined compromised patient safety or interfered with study evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| intracranial progression-free survival;objective response rate;disease control rate; | — |
Countries
China
Contacts
Public ContactShao Qian
Shandong Cancer Hospital and Institute Affiliated to Shandong University
Outcome results
None listed