NCT06674343

Furmonertinib 160mg as First-line Treatment in Locally Advanced or Metastatic NSCLC With EGFR Classical Mutations

The Efficacy and Safety of Furmonertinib 160mg as First-line Treatment in Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With EGFR Classical Mutations, a Prospective, Single-arm, Multicenter Clinical Study

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy, safety, recurrence site, recurrence pattern and resistance mechanism of 160mg furmonertinib as first-line therapy in advanced or metastatic non-small cell lung cancer (NSCLC) patients with EGFR classical mutations(19Del or L858R).

Detailed description

To evaluate the PFS, ORR, DCR, OS, CNS ORR CNS DCR, CNS PFS, safety, recurrence site, recurrence pattern and resistance mechanism of 160mg furmonertinib as first-line therapy in advanced or metastatic non-small cell lung cancer (NSCLC) patients with EGFR classical mutations(19Del or L858R).

Conditions

• Advanced or Metastatic Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Furmonertinib	Furmonertinib 160mg, once daily, orally. Other Names: AST2818

Timeline

• Start date: 2024-07-15
• Primary completion: 2026-12-31
• Completion: 2028-12-31
• First posted: 2024-11-05
• Last updated: 2024-11-05

Locations

1 site across 1 country: China