Armatinib Alone or in Combination With SRT for Brain Metastases EGFR-mutated Non-small Cell Lung Cancer

Recruiting Phase 3 Interventional Study
Non-small Cell Lung Cancer Metastatic
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
300 (estimated)
Sponsor
Shanghai Cancer Hospital, China · Other
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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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. aged 18 years or older (including 18 years) and up to 75 years (including 75 years) 2. histologically confirmed NSCLC (by AJCC 8th edition lung cancer staging criteria) 3. asymptomatic or minimally symptomatic brain metastases (i.e., headache, nausea, or seizures responding t…
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