This is a multicenter, randomized, open label, phase III study.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
606
Almonertinib 110mg PO once daily
500 milligrams per square meter (mg/m²) Pemetrexed
75mg/m² Cisplatin taken intravenously (IV) once every 3 weeks concurrently
Disease free survival (DFS)
Defined as the time from the date of randomization until the date of disease recurrence or death (by any cause in the absence of recurrence)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Disease free survival (DFS)
Defined as the proportion of patients alive and disease free at 2, 3 ,4and 5 years, respectively, estimated from Kaplan Meier plots of the primary endpoint of DFS at the time of the primary analysis.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Overall Survival (OS)
Defined as the time from the date of randomization until date of death due to any cause.
Time frame: Start of study drug to Survival Endpoint through study completion, an average of 5 years, assessed up to 100 months
Patient health-related quality of life and symptoms (HRQoL) by SF-36v2 Health Survey
Defined as a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section and the scores range from 0-100. A score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Time frame: From date of randomization until treatment completion or discontinuation, assessed up to 100 months
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Chinese Academy of Medical Science
Beijing, Beijing Municipality, 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
...and 24 more locations