NCT04685070

Neoadjuvant HS-10296 (Almonertinib) Therapy for Potential Resectable Stage III EGFR Mutation-Positive Non-small Cell Lung Cancer

Neoadjuvant HS-10296 (Almonertinib) Therapy for Potential Resectable Stage III EGFR Mutation-Positive Non-small Cell Lung Cancer: A Single-Arm, Open-Label, Phase II Clinical Trial

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II, single-arm, open-label study to evaluate the efficacy and safety of the third generation tyrosine kinase inhibitors (TKIs) Almonertinib (HS-10296) as neoadjuvant and adjuvant therapy for potential resectable stage III EGFR mutation-positive Non-small Cell Lung Cancer.

Conditions

• Non-small Cell Lung Cancer Stage III

Interventions

Type	Name	Description
DRUG	HS-10296 (Almonertinib)	Neoadjuvant treatment stage: HS-10296 110mg, qd, po, 4 weeks per cycle, 2-4 cycles in total; Surgical treatment stage: CR + PR patients and SD + PD patients who could still undergo surgery will receive radical surgery; Adjuvant treatment stage: CR, PR and SD patients who have been treated surgically: HS-10296 110mg, qd, po, up to 48 weeks (including neoadjuvant stage). PD patients: transferred into medical oncology or/and radiation oncology and receive comprehensive therapy.

Timeline

• Start date: 2021-12-14
• Primary completion: 2022-12-31
• Completion: 2027-12-31
• First posted: 2020-12-28
• Last updated: 2024-08-14

Locations

1 site across 1 country: China