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Brief Title: Efficacy and Safety of Almonertinib Combined With or Without Chemotherapy as an Adjuvant Treatment for Stage II-IIIA Non-small Cell Lung Carcinoma Following Complete Tumour Resection
Official Title: Efficacy and Safety of Almonertinib Combined With or Without Chemotherapy as an Adjuvant Treatment for EGFR Mutation Positive Stage II-IIIA Non-small Cell Lung Carcinoma Following Complete Tumour Resection: A Multicenter, Randomized Controlled, Open-label Clinical Study
Study ID: NCT04762459
Brief Summary: This is a multicenter, randomized, open label, phase III study.
Detailed Description: This is a multicenter, randomized, open label, phase III study assessing the efficacy and safety of Almonertinib combined with or without chemotherapy as an adjuvant treatment in patients with epidermal growth factor receptor (EGFR) mutation positive stage II-IIIA non-squamous NSCLC following complete tumour resection: Eligible patients will be randomized to receive either Almonertinib alone (110mg, po, once daily) or Almonertinib (110mg, po, once daily) plus pemetrexed (500mg/m2, iv) and cisplatin (500mg/m2, iv) or pemetrexed (500mg/m2, iv) plus cisplatin (500mg/m2, iv) in a 3:2:1 ratio.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Chinese Academy of Medical Science, Beijing, Beijing, China
Cancer Hospital Chinese Academy of Medical Sciences, Beijing, , China
Peking Union Medical College Hospital, Beijing, , China
Hunan Cancer Hospital, Changsha, , China
Sichuan Cancer Hospital, Chendu, , China
Sichuan Provincial People's Hospital, Chengdu, , China
The First Affiliated Hospital of Chongqing Medical University, Chongqing, , China
Fujian Medical University Consonancy Hospital, Fuzhou, , China
Guangdong Provincial People's Hospital, Guangzhou, , China
The Second Affiliated Hospital of Zhejiang University School Of Medicine, Hangzhou, , China
The First People's Hospital of Yunnan Province, Kunming, , China
Yunnan Cancer Hospital, Kunming, , China
JiangXi Cancer Hospital, Nanchang, , China
The First Affiliated Hospital of Nanchang University, Nanchang, , China
Jiangsu Cancer Hospital, Nanjing, , China
Jiangsu Provincial People's Hospital, Nanjing, , China
Ningbo Medical Center Li Huili Hospital, Ningbo, , China
Qingdao Municipal Hospital, Qingdao, , China
Fudan University Shanghai Cancer Center, Shanghai, , China
ShangHai Chest Hospital ShangHai JiaoTong University, Shanghai, , China
ShangHai Pulmonary Hospital, Shanghai, , China
Liaoning Cancer Hospital, Shenyang, , China
Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen Center, Shenzhen, , China
Hebei Cancer Hospital, Shijiazhuang, , China
West China Hospital,Sichuan University, Sichuan, , China
The First Affiliated Hospital of Soochow University, Suzhou, , China
Thoracic Surgery Department Of The ShanXi Provincial Cancer Hospital, Taiyuan, , China
Tianjin Chest Hospital, Tianjin, , China
Weifang People's Hospital, Weifang, , China
The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, , China
Wuhan Union Hospital Of China, Wuhan, , China
First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, , China
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, , China
Affiliated Tumor Hospital of Xinjiang Medical University, Ürümqi, , China