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Objective:Patients with asymptomatic or minimally symptomatic Stage IV EGFR-positive NSCLC with baseline intracranial metastases.
Aim: To investigate the timing, efficacy and safety of radiotherapy in patients with EGFR positive brain metastases treated with armatinib alone or combined with stereotactic radiotherapy.
Method: Almonertinib: specification 55mg/tablet; The dosage is 110 mg / day (2 tablets / day) orally once a day; SBRT: 3-5 doses of 27-40 Gy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GroupA | Experimental | Intracranial stereotactic radiotherapy (27-40 Gy/3-5f) was administered to all intracranial lesions on the first day of oral administration of Almonertinib |
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| GroupB | Experimental | Two successive MR enhancements after oral administration of Almonertinib suggest that intracranial lesions are maximally remission, and stereotactic body radiotherapy is given to all lesions (27-40Gy/3-5f) |
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| GroupC | Experimental | oral administration of Almonertinib |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Almonertinib | Drug | The dosage is 110 mg/day (2 tablets/day) orally once a day |
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| Measure | Description | Time Frame |
|---|---|---|
| iPFS | Intracranial to time to disease progression | up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
Received any of the following treatments:
patients with NSCLC EGFR driver gene negative or known severe allergic reactions (≥ grade 3) to TKIs drugs;
patients who are unable to undergo MR examination
brain metastases requiring surgical decompression;
the presence of a previous solid organ or hematologic transplant; clinically active diverticulitis, abdominal abscess, gastrointestinal obstruction; the presence of clinically uncontrollable pleural effusion/peritoneal effusion
malignancy other than non-small cell lung cancer within 5 years prior to enrollment, excluding adequately treated carcinoma in situ of the cervix, basal cell or squamous epithelial cell skin cancer of the skin, localized prostate cancer after radical surgery, and ductal carcinoma in situ of the breast;
having unremitting residual toxicity of prior therapy greater than CTCAE grade 1 at the time of initiation of study treatment, with the exception of alopecia and grade 2 neurotoxicity from prior chemotherapy;
have any serious or poorly controlled systemic disease, such as active bleeding-prone body or active infection, as judged by the investigator. Chronic illnesses that do not require exclusion;
the known presence of a psychiatric illness or substance abuse condition that may have an impact on compliance with trial requirements
any serious or uncontrolled ocular pathology that, in the judgment of the physician, may increase the safety risk to the patient
a known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive)
patients who, in the judgment of the investigator, are likely to be poorly compliant with the procedures and requirements of the study.](streamdown:incomplete-link)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| C000718108 | aumolertinib |
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| SBRT | Radiation | SRT, 27Gy-40Gy/3-5f |
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