NCT04853342

To Assess the Efficacy and Safety of Furmonertinib Versus Placebo, in Patients With Epidermal Growth Factor Receptor Mutation Positive Stage II-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy

A Phase III, Double-blind, Randomized, Placebo-Controlled Multi-centre, Study to Assess the Efficacy and Safety of Furmonertinib (AST2818) Versus Placebo, in Patients With Epidermal Growth Factor Receptor Mutation Positive Stage II-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 318 (estimated)
• Sponsor: Allist Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 3 double-blind, randomized, placebo-controlled, study to assess the efficacy and safety of Furmonertinib (AST2818) versus placebo in patients with stage II-IIIA non-small cell lung cancer (NSCLC) with centrally confirmed, most common sensitising EGFR mutations (Ex19Del and L858R) either alone or in combination with other EGFR mutations as confirmed by a central test, who have had complete tumour resection, with or without postoperative adjuvant chemotherapy.

Conditions

• Non-small Cell Lung Carcinoma

Interventions

Type	Name	Description
DRUG	Drug: Furmonertinib 80 mg	The initial dose of Furmonertinib 80 mg once daily
DRUG	Furmonertinib 80 mg placebo	The initial dose of Furmonertinib 80 mg once daily

Timeline

• Start date: 2021-06-07
• Primary completion: 2026-01-01
• Completion: 2030-01-01
• First posted: 2021-04-21
• Last updated: 2025-04-04

Locations

1 site across 1 country: China