NCT04643847

A Phase II Trial of Upfront Radiotherapy Plus Almonertinib for Epidermal Growth Factor Receptor(EGFR)-Mutant Non-small-cell Lung Cancer(NSCLC) Patients With Brain Metastases

Upfront Radiotherapy Combined With Almonertinib for Brain Metastasis in Non-small Cell Lung Cancer With EGFR Mutation: A Prospective Single-arm Phase II Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (estimated)
• Sponsor: First People's Hospital of Hangzhou · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Almonertinib is a three-generation epidermal growth factor receptor tyrosine kinase inhibitor(EGFR-TKI), which has shown competitive potential in the second-line treatment against first-generation TKIs. This study intends to assess the efficacy and safety of stereotactic radiosurgery with sequential almonertinib in treatment-naive EGFR-mutant NSCLC patients with brain metastases.

Conditions

• EGFR Positive Non-small Cell Lung Cancer
• Brain Metastases

Interventions

Type	Name	Description
DRUG	Almonertinib	110mg Almonertinib is administered orally daily since the first day after stereotactic radiosurgery treatment (total dose 30 Gy, 5 fractions, day1, 3, 5, calibrated by CBCT before each treatment). For patients who are assessed as oligometastasis three months after Almonertinib treatment, SBRT is recommended for oligometastatic lesions (The number of lesions received SBRT and radiation dose are not standardized).

Timeline

• Start date: 2020-11-30
• Primary completion: 2022-11-30
• Completion: 2023-11-30
• First posted: 2020-11-25
• Last updated: 2020-11-25

Locations

1 site across 1 country: China