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Almonertinib is a three-generation epidermal growth factor receptor tyrosine kinase inhibitor(EGFR-TKI), which has shown competitive potential in the second-line treatment against first-generation TKIs. This study aims to explore the efficacy and safety of different doses of almonertinib in the first-line and second-line treatment of brain metastases/meningeal metastases in NSCLC patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| almonertinib 110mg PO once daily | Experimental |
| |
| almonertinib 160mg PO once daily | Experimental |
| |
| almonertinib 220mg PO once daily | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| almonertinib | Drug | Patients was given a standard dose of 110mg/day of almonertinib, orally, and the first efficacy evaluation was carried out 4 weeks later. If the patient's lungs and/or other parts of the disease (PD) progress, then leave the group to receive other treatment; if the patient's lungs If the brain and other parts are stable or relieved and the brain has not progressed, continue the original dose treatment, and evaluate the effect every 8 weeks. Until the patient's lungs and/or other parts progress (PD), then leave the group to receive other treatment; if If the patient's lungs and other parts are stable or relieved and the brain is progressing, the dose of almonertinib can be increased to 165mg/day, orally ± radiotherapy (the investigator's decision), and then the efficacy will be evaluated every 8 weeks until the patient's lungs and/ Or there is progress (PD) in other parts, then the group will receive other treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| iPFS | Intracranial progression-free survival (iPFS) | Up to approximately 3 years after the last patient is randomized |
| Measure | Description | Time Frame |
|---|---|---|
| DCR | Disease control rate (DCR) | Up to approximately 3 years after the last patient is randomized |
| PFS | progression-free period (PFS) |
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Inclusion Criteria:
Queue 1
Queue 2
Queue 3
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huijuan Wang, MD | Contact | 18638561588 | 18638561588@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Huijuan Wang, MD | Henan Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | 450003 | China |
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|
| LM-first line treatment | Drug | Patients were given a standard dose of almonertinib 110 mg/day, orally, and the first efficacy evaluation was performed 4 weeks later. If there was no disease progression in two consecutive evaluations, the dose of almonertinib was increased to 165 mg /Day, oral ± radiotherapy (decided by the investigator), continue to evaluate the efficacy every 4 weeks until the patient progresses; if there is no disease progression in two consecutive assessments, the dose of almonertinib is increased to 220 mg/day, orally ± Radiotherapy treatment (determined by the investigator), continue to evaluate the efficacy every 4 weeks until the patient progresses. |
|
| LM-second line treatment | Drug | Patients were given a standard dose of almonertinib 110 mg/day, orally, and the first efficacy evaluation was performed 4 weeks later. If there was no disease progression in two consecutive evaluations, the dose of almonertinib was increased to 165 mg /Day, oral ± radiotherapy (decided by the investigator), continue to evaluate the efficacy every 4 weeks until the patient progresses; if there is no disease progression in two consecutive assessments, the dose of almonertinib is increased to 220 mg/day, orally ± Radiotherapy treatment (determined by the investigator), continue to evaluate the efficacy every 4 weeks until the patient progresses. |
|
| Up to approximately 3 years after the last patient is randomized |
| OS | overall survival (OS) | Up to approximately 3 years after the last patient is randomized |
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D055756 | Meningeal Carcinomatosis |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008577 | Meningeal Neoplasms |
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| ID | Term |
|---|---|
| C000718108 | aumolertinib |
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