Armatinib Alone or in Combination With SRT for Brain Metastases EGFR-mutated Non-small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Cancer Hospital, China
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
aged 18 years or older (including 18 years) and up to 75 years (including 75 years)
histologically confirmed NSCLC (by AJCC 8th edition lung cancer staging criteria)
asymptomatic or minimally symptomatic brain metastases (i.e., headache, nausea, or seizures responding to dexamethasone/analgesic/antiepileptic agents at a stable drug dose for at least 3 days);
brain metastases must meet the following criteria on diagnostic MRI: at least one lesion that can be classified as measurable disease according to RANO-BM, ≤ 10 brain or brainstem metastases
Disqualifiers
Currently participating in an interventional clinical study treatment or received another study drug within 4 weeks prior to the first dose
Received palliative intracranial radiation therapy prior to the first dose
Patient has undergone major surgery (including biopsy) or major trauma within 4 weeks prior to the first dose of study drug; patients who are expected to require major surgery during the study period
Patients previously treated with EGFR-TKI.
Trial design
Design model
Parallel
Treatments tested in this trial
Almonertinib
DrugThe dosage is 110 mg/day (2 tablets/day) orally once a day
SBRT
RadiationSRT, 27Gy-40Gy/3-5f
Treatment groups
300 Participants
are divided into 3 treatment groupsGroup A: GroupAExperimental treatment 2 interventions
Group B: GroupBExperimental treatment 2 interventions
Group C: GroupCExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
iPFS
Intracranial to time to disease progression
Time frame
up to 12 monthsSponsors and contacts
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Source ClinicalTrials.gov