RecruitingPhase 3NCT04853342

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

Sponsor

Allist Pharmaceuticals, Inc.

Enrollment

318 participants

Start Date

Jun 7, 2021

Study Type

INTERVENTIONAL

Conditions

Non-Small-Cell Lung Carcinoma

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a targeted drug called furmonertinib (taken as a pill) can prevent lung cancer from coming back in people who have had surgery to remove their non-small cell lung cancer (NSCLC) that carries a specific gene mutation called EGFR. **You may be eligible if...** - You are 18 years or older - You have had surgery to completely remove your non-small cell lung cancer - Your cancer was stage IB, II, or IIIA after surgery - Lab tests confirmed your tumor has a common EGFR mutation **You may NOT be eligible if...** - Your tumor does not have an EGFR mutation - Your cancer has returned or spread since surgery - Your cancer was squamous cell type Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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