Phase III Study of Almonertinib as Maintenance Therapy After Chemoradiation in Adults With Stage III Unresectable EGFR Mutation-positive Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating the effectiveness and safety of Almonertinib compared to a placebo in patients with stage III unresectable non-small cell lung cancer NSCLC that has specific mutations in the epidermal growth factor receptor EGFR. This phase III, randomized, double-blind, placebo-controlled study focuses on patients whose disease has not progressed after chemoradiation, including those with common EGFR mutations such as Ex19Del and L858R. The goal is to understand how well Almonertinib works as a maintenance therapy following chemoradiation. Participants will be randomly assigned in a 21 ratio to receive either Almonertinib or a placebo after completing chemoradiation within the past 6 weeks. Almonertinib or placebo is given daily with an initial dose of 110 mg, which can be reduced to 55 mg if needed. Treatment continues until disease progression, unacceptable side effects, or other reasons for stopping occur. After progression, patients may receive open-label Almonertinib if their doctor believes it is beneficial. During the study, tumor scans will be performed at the start, then approximately every 8 weeks for up to 48 weeks, and every 12 weeks thereafter for up to 3 to 4 years. Researchers will monitor progression-free survival, overall survival, tumor response, and safety through adverse event tracking. Participants will also undergo evaluations of brain metastases and other health assessments throughout the study period. The total participation may last several years based on ongoing monitoring and treatment response.

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