Study of Almonertinib and Anlotinib as First Treatment for Advanced Non-small Cell Lung Cancer with EGFR and TP53 Mutations

What this Trial Is About

Researchers are studying the effectiveness and safety of combining almonertinib with anlotinib as the first treatment for adults with advanced non-small cell lung cancer NSCLC that has specific mutations in the EGFR and TP53 genes. This single-arm, exploratory study focuses on patients with non-squamous NSCLC who have not received prior systemic therapy or have relapsed after adjuvant chemotherapy. The study aims to measure progression-free survival PFS as the main outcome, along with overall survival OS, objective response rate ORR, and safety as secondary outcomes. Participants receive almonertinib at a dose of 110 mg daily and anlotinib at 12 mg daily, starting on the first day of each treatment cycle. Treatment cycles last three weeks, with anlotinib taken for two weeks followed by one week off. This regimen continues until the disease progresses or side effects become intolerable. The study includes regular assessments of disease status at baseline, 6 weeks, 12 weeks, and every 9 weeks thereafter using RECIST 1.1 criteria. During the study, participants undergo evaluations to monitor tumor response, safety, and side effects, following NCI CTCAE version 4.0. Safety is closely tracked, especially when adverse events occur, and patients are followed until these events resolve. After stopping treatment, survival status is checked every three months until death. Statistical methods like the Kaplan-Meier curve are used to analyze progression-free and overall survival, while descriptive statistics assess response rates and disease control.

Almonertinib Combined With Anlotinib as First-line Treatment for Advanced Non-small Cell Lung Cance