NCT05165355

Adjuvant Targeted-therapy for Patients With Resected High-risk EGFR-mutant Stage IB-IIA Non-small Cell Lung Carcinoma

A Phase II, Single-armed Study to Assess the Efficacy and Safety of Furmonertinib in Patients With Epidermal Growth Factor Receptor Mutation Positive Stage IB-IIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Tongji University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single-armed study designed to evaluate the safety and efficacy of adjuvant targeted-therapy in patients with epidermal growth factor receptor mutation positive stage IB-IIA non-small cell lung carcinoma and high-risk of recurrence following complete tumor resection. The primary endpoint: 2-year DFS rate; The second endpoint: DFS

Conditions

• NSCLC
• EGF-R Positive Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Furmonertinib	Furmonertinib (80 mg orally, once daily) for 3 years.

Timeline

• Start date: 2021-12-28
• Primary completion: 2024-11-01
• Completion: 2025-02-01
• First posted: 2021-12-21
• Last updated: 2022-01-18

Locations

1 site across 1 country: China