RecruitingPhase 3NCT05800223

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

Prospective, Multicenter, Randomized Controlled, Phase III Clinical Study of Armatinib Alone or in Combination With Stereotactic Body Radiotherapy (SRT) for First-line Treatment of Brain Metastases From EGFR-mutated Non-small Cell Lung Cancer


Sponsor

Shanghai Cancer Hospital, China

Enrollment

300 participants

Start Date

Jan 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether a targeted therapy drug called armatinib — used alone or combined with stereotactic radiation — works better for lung cancer that has spread to the brain. It focuses specifically on patients whose tumors have a specific genetic change called an EGFR mutation. **You may be eligible if:** - You are between 18 and 75 years old - You have non-small cell lung cancer (NSCLC) with an EGFR mutation (exon 19 deletion or exon 21 L858R) - Cancer has spread to the brain (up to 10 brain spots), but symptoms are mild or none - You have not received prior systemic therapy (other than short-term neoadjuvant/adjuvant treatment) - You are in good general health (ECOG score 0 or 1) - Your blood counts, liver, and kidney values are within normal ranges **You may NOT be eligible if:** - You have a different EGFR mutation or no EGFR mutation - Your brain metastases are causing severe symptoms not controlled by medication - You have more than 10 brain metastases - You have received prior EGFR-targeted therapy - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAlmonertinib

The dosage is 110 mg/day (2 tablets/day) orally once a day

RADIATIONSBRT

SRT, 27Gy-40Gy/3-5f


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT05800223


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