RecruitingPhase 3NCT04951635

A Phase III Study to Assess the Effects of Almonertinib Following Chemoradiation in Patients With Stage III Unresectable Non-small Cell Lung Cancer

A Phase III, Randomised, Double-blind, Placebo-controlled, Multi-centre Study of Almonertinib as Maintenance Therapy in Patients With Locally Advanced, Unresectable EGFR Mutation-positive Non-Small Cell Lung Cancer (Stage III) Who Have Not Progressed Following Definitive, Platinum-based Chemoradiation Therapy


Sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Enrollment

150 participants

Start Date

Mar 18, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

To assess the efficacy and safety of Almonertinib versus placebo following chemoradiation in patients with stage III unresectable epidermal growth factor receptor mutation-positive (EGFRm+) non-small cell lung cancer (NSCLC).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase III study is testing whether a targeted lung cancer drug called almonertinib (an EGFR inhibitor) — taken after completing standard chemoradiation (chemotherapy plus radiation) — improves outcomes for people with locally advanced, inoperable (stage III) non-small cell lung cancer whose tumors have a specific genetic mutation (EGFR exon 19 deletion or L858R mutation). **You may be eligible if...** - You are 18 or older with confirmed stage III non-squamous non-small cell lung cancer that cannot be surgically removed - Your tumor has an EGFR mutation (specifically Ex19Del or L858R) - You have completed at least 2 cycles of platinum-based chemotherapy combined with radiation (54–66 Gy), finishing no more than 6 weeks ago - Your cancer did not progress during or after chemoradiation - You are in good health (WHO performance status 0–1) **You may NOT be eligible if...** - You have previously used an EGFR-targeted drug (like erlotinib, gefitinib, or osimertinib) - You have had prior chemotherapy or immunotherapy for this lung cancer outside of the standard chemoradiation - You have a history of lung scarring (interstitial lung disease) - You have ongoing significant side effects (grade 2 or above) from prior treatment - You have significant heart problems (abnormal QT interval, severe heart failure) - You have uncontrolled infections, active hepatitis B or C, or HIV - You are pregnant or breastfeeding 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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Interventions

DRUGAlmonertinib

The initial dose of Almonertinib 110 mg daily can be reduced to 55 mg daily under specific conditions. Treatment can continue until disease progression, unacceptable toxicity or other discontinuation criteria are met. The 2:1 ratio (Almonertinib to placebo).

DRUGPlacebo Almonertinib

The initial dose of Placebo Almonertinib 110 mg daily can be reduced to 55 mg daily under specific conditions. Treatment can continue until disease progression, unacceptable toxicity or other discontinuation criteria are met. The 2:1 ratio (Almonertinib to placebo).


Locations(1)

Shandong Cancer Hospital

Ji'nan, Shandong, China

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NCT04951635


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