NCT06227897

Aumolertinib in EGFR-Mutant Resected Stage IB-IIIA NSCLC (AERESA).

A Single-Arm, Open-Lable Study of Adjuvant Aumolertinib for Completely Resected Stage IB-IIIA Non-Small-Cell Lung Cancer With EGFR Exon 19 Deletion or L858R Mutations.

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Aumolertinib (almonertinib; HS-10296) is a novel third-generation EGFR-TKI showing activity against EGFR-sensitizing mutations and EGFR T790M mutation. The third-generation EGFR-TKI osimertinib has been approved in the adjuvant setting. This study is to studying 3-year aumolertinib as adjuvant therapy to see how well it works in treating patients with resected stage IB-IIIA NSCLC harboring sensitizing EGFR mutations.

Detailed description

Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) show great efficacy in patients with advanced non-small cell lung cancer (NSCLC) with EGFR mutations. Aumolertinib (almonertinib; HS-10296) is a novel third-generation EGFR-TKI. Aumolertinib showed activity against EGFR-sensitizing mutations and EGFR T790M mutation. In the phase III AENEAS trial, aumolertinib had improved efficacy to gefitinib with similar safety. In the phase II APOLLO trial, aumolertinib is effective and well-tolerated for patients with advanced NSCLC having an EGFR T790M mutation after disease progression on first- and second-generation EGFR TKI therapy. The third-generation EGFR-TKI osimertinib has been approved in the adjuvant setting. This study is to studying 3-year aumolertinib as adjuvant therapy to see how well it works in treating patients with resected stage IB-IIIA NSCLC harboring sensitizing EGFR mutations.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	Aumolertinib	Aumolertinib 110 mg per day orally for 3 years.

Timeline

• Start date: 2024-06-01
• Primary completion: 2026-04-01
• Completion: 2029-04-01
• First posted: 2024-01-29
• Last updated: 2024-12-10

Locations

1 site across 1 country: China