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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 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 318

Last updated 2025-04-04

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Allist Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Jianxing He, PHD · The First Affiliated Hospital of Guangzhou Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-07
Primary Completion
2026-01-31
Completion
2030-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04853342 on ClinicalTrials.gov