drugset / Trial / 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

NCT04853342

Phase 3 Recruiting 318 enrolled Allist Pharmaceuticals, Inc.
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2021-06-07
Primary completion
2026-01
Completion
2030-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Firmonertinib Small molecule 80 mg Oral