NCT04762459

Efficacy and Safety of Almonertinib Combined With or Without Chemotherapy as an Adjuvant Treatment for Stage II-IIIA Non-small Cell Lung Carcinoma Following Complete Tumour Resection

Efficacy and Safety of Almonertinib Combined With or Without Chemotherapy as an Adjuvant Treatment for EGFR Mutation Positive Stage II-IIIA Non-small Cell Lung Carcinoma Following Complete Tumour Resection: A Multicenter, Randomized Controlled, Open-label Clinical Study

• Status: Enrolling By Invitation
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 606 (estimated)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, open label, phase III study.

Detailed description

This is a multicenter, randomized, open label, phase III study assessing the efficacy and safety of Almonertinib combined with or without chemotherapy as an adjuvant treatment in patients with epidermal growth factor receptor (EGFR) mutation positive stage II-IIIA non-squamous NSCLC following complete tumour resection: Eligible patients will be randomized to receive either Almonertinib alone (110mg, po, once daily) or Almonertinib (110mg, po, once daily) plus pemetrexed (500mg/m2, iv) and cisplatin (500mg/m2, iv) or pemetrexed (500mg/m2, iv) plus cisplatin (500mg/m2, iv) in a 3:2:1 ratio.

Conditions

• Non-small Cell Lung Carcinoma

Interventions

Type	Name	Description
DRUG	Almonertinib	Almonertinib 110mg PO once daily
DRUG	Pemetrexed	500 milligrams per square meter (mg/m²) Pemetrexed
DRUG	Cisplatin	75mg/m² Cisplatin taken intravenously (IV) once every 3 weeks concurrently

Timeline

• Start date: 2021-08-01
• Primary completion: 2026-05-01
• Completion: 2029-05-01
• First posted: 2021-02-21
• Last updated: 2022-02-24

Locations

34 sites across 1 country: China