NCT04687241

Almonertinib Versus Placebo as Adjuvant Therapy in Resected Stage II-IIIB Non-Small Cell Lung Cancer With EGFR-sensitive Mutations

Efficacy and Safety of Almonertinib Versus Placebo as Adjuvant Therapy for Subjects With Resected Stage II-IIIB NSCLC Harboring EGFR-sensitive Mutations: A Randomized, Controlled, Double-blind, Phase 3 and Multicenter Clinical Study

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 192 (estimated)
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To assess the efficacy and safety of Almonertinib versus placebo in patients with epidermal growth factor receptor mutation-positive (EGFRm+) stage II-IIIB non-small cell lung cancer (NSCLC), following complete tumor resection with or without adjuvant chemotherapy.

Detailed description

HS-10296-302 is a randomized, placebo-controlled, double-blind, multicenter, phase III study to assess the efficacy and safety of Almonertinib versus placebo in stage II-IIIB NSCLC with EGFRm+ following complete tumor resection, with or without postoperative adjuvant chemotherapy (2\~4 cycles of platinum-based doublet). Eligible patients are randomized to receive either Almonertinib (110 mg orally, once daily) or placebo (110 mg orally, once daily) in a 1:1 ratio.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Almonertinib	The initial dose of Almonertinib 110 mg daily can be reduced to 55 mg daily under specific conditions.
DRUG	Placebo Almonertinib	Placebo Almonertinib

Timeline

• Start date: 2021-04-30
• Primary completion: 2024-07-08
• Completion: 2029-01-01
• First posted: 2020-12-29
• Last updated: 2024-11-07

Locations

1 site across 1 country: China