Almonertinib Combined With Anlotinib as First-line Treatment for Advanced Non-small Cell Lung Cance
This study tests a combination of two cancer drugs (almonertinib and anlotinib) for treating advanced lung cancer in patients whose tumors have specific genetic mutations. Researchers want to see if using these two drugs together is more effective and safe than standard treatments.
Key Objective:This trial is testing whether combining almonertinib with anlotinib can improve how well advanced lung cancer responds to treatment in patients with EGFR and TP53 mutations.
Who to Consider:Patients with advanced non-small cell lung cancer that has EGFR-sensitive mutations and TP53 mutations who have not received prior treatment should consider enrolling.
Trial Parameters
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Brief Summary
To evaluate the efficacy and safety of almonertinib plus anlotinib as first-line treatment for advanced non-small cell lung cancer with EGFR sensitive mutation and TP53 mutation. This study is an exploratory single-arm study. The specific treatment regimen is as follows: Non-squamous NSCLC: almonertinib (110 mg/d) plus anlotinib (12mg/d) is started on the first day of each treatment cycle and administered every three weeks until disease progression or intolerable toxicity. Anlotinib was given for two weeks, followed by one week off. Patients are assessed for measurable disease at baseline, 6 weeks, 12 weeks after starting treatment, and every 9 weeks thereafter according to RECIST 1.1 criteria during the treatment period until disease progression or intolerable toxicity withdrawal. Following discontinuation of treatment, subjects are followed for survival status every 3 months until death. Subject safety was assessed during treatment according to NCI CTCAE Version 4.0 criteria. Subjects who experience an AE should be followed until the AE returns to baseline. The primary endpoints is Progression-free survival (PFS) . Secondary endpoints include objective response rate (ORR), overall survival (OS) and safety (NCI CTCAE v 4.0). Statistical methods: The PFS curve was estimated using the Kaplan-Meier method for the largest population to be analyzed. The confidence interval method was used as the criterion for the main analysis. OS was calculated in the same way as the secondary endpoint. Descriptive statistics will be used to analyze ORR, DCR, etc. It is expected that almonertinib plus anlotinib as first-line treatment will prolong median PFS and OS of advanced non-small cell lung cancer with EGFR sensitive mutation and TP53 mutation patients.
Eligibility Criteria
Inclusion Criteria: Metastatic Non-squamous NSCLC is histologically or cytologically proven to be inoperable and cannot receive radical concurrent chemoradiotherapy. The conventional TNM stage was identified as stage IIIa-Ⅳb according to the International Association for the Study of Lung Cancer and the American Joint Committee on the Classification of Cancer 8th edition TNM Staging of Lung Cancer. Patients with EGFR mutation and TP53 mutation advanced Non-squamous NSCLC. Patients who had not previously received systemic radiotherapy and chemotherapy or who had relapsed for more than 6 months of follow-up after onset of adjuvant chemotherapy. At least one measurable lesion as determined by RECIST criteria. Male or female patients, age: 18-75 years of age. Performance score 0-1 based on Eastern Cooperative Oncology Group (ECOG) test. Expected survival period ≥12 weeks. Serum absolute number of neutrophils≥ 1.5 x 10\^9/L, platelet ≥ 100 x10\^9/L, and hemoglobin≥ 90g/L. Serum bilirubin≤1.