NCT05800223

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Shanghai Cancer Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Non-small Cell Lung Cancer Metastatic

Interventions

Type	Name	Description
DRUG	Almonertinib	The dosage is 110 mg/day (2 tablets/day) orally once a day
RADIATION	SBRT	SRT, 27Gy-40Gy/3-5f

Timeline

• Start date: 2023-01-01
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2023-04-05
• Last updated: 2023-04-05

Locations

1 site across 1 country: China