The "Efficacy and Safety of Almonertinib Mesilate VS Placebo in Adjuvant Therapy of Stage II-IIIB NSCLC with Positive EGFR Sensitive Mutation: A Randomized, Controlled, Double-Blind, Phase III, Multicenter Clinical Study" (Clinical Study Protocol No.: HS-10296-302) initiated by Jiangsu Hansoh Pharmaceutical Group Co., Ltd. has been approved by the National Medical Products Administration and the ethics committee of the study leader, and Professor Cheng Ying of Jilin Cancer Hospital will lead the clinical study in more than 40 hospitals nationwide.
Introduction to the study
This is a randomized, controlled, double-blind, multicenter phase III clinical study to evaluate the efficacy and safety of almonertinib mesilate (hereinafter referred to as "almonertinib") VS placebo in stage II-IIIB NSCLC patients with positive epidermal growth factor receptor (EGFR) sensitive mutation after complete tumor resection and standard adjuvant therapy. Eligible patients are randomly assigned to the almonertinib group (experimental group) or the placebo group (control group) at a ratio of 1:1. The main endpoint of the study is to compare the disease-free survival (DFS) of patients in the almonertinib group VS the placebo group.
Eligibility criteria
1. Voluntarily participate in this clinical study, understand the study procedures, and be able to sign the informed consent form in writing;
2. Aged 18 years old or above;
3. Histologically confirmed diagnosis of primary NSCLC with predominantly non-squamous cell carcinoma histology;
4. Total resection of primary lung cancer (R0) and systematic lymph node dissection must be performed;
5. Patients with stage II, IIIA and IIIB (only T3N2M0) NSCLC confirmed by postoperative pathology, with the disease staging determined according to the 8th edition lung cancer staging criteria of AJCC/UICC;
6. Confirmed as EGFR sensitive mutation (including exon 19 deletion or L858R mutation, existing alone or coexisting with mutations in other EGFR loci, and patients with positive T790M mutation can be enrolled).
Contact information
For more information about this study, please contact the outpatient service of the Clinical Medical Research Translation Center of Jilin Cancer Hospital.
Contact person: Wang Xinmiao
Mobile: 13634400173 (WeChat ID is the same as the mobile number)
