To assess the efficacy and safety of Almonertinib versus placebo in patients with epidermal growth factor receptor mutation-positive (EGFRm+) stage II-IIIB non-small cell lung cancer (NSCLC), following complete tumor resection with or without adjuvant chemotherapy.
Name: Almonertinib
Name: Placebo Almonertinib
Description: DFS is defined as the time from randomization to the recurrence of tumor as assessed by IRC or death from any cause on study. The patients will receive long-term follow-up including chest and abdominal CT every 12 weeks during Year 1, then every 24 weeks during Years 2 to 5, and every 48 weeks during Year 6 and onwards; MRI/CT of brain, and bone scan performed every 48 weeks.
Measure: DFS (Disease free survival) assessed by IRC (Independent Review Committee) Time: From the time of randomization to recurrence of tumor or death, approximately 4 years.Description: The patients will receive long-term follow-up including chest and abdominal CT every 12 weeks during Year 1, then every 24 weeks during Years 2 to 5, and every 48 weeks during Year 6 and onwards; MRI/CT of brain, and bone scan performed every 48 weeks. DFS is defined as the time from randomization to the recurrence of tumor as assessed by INVs or death from any cause on study.
Measure: DFS (Disease free survival) assessed by INVs (Investigators) Time: From the time of randomization to recurrence of tumor or death, approximately 4 years.Description: Defined as the proportion of patients alive and disease free at 2, 3 and 5 years, respectively, estimated from Kaplan Meier plots of the primary endpoint of DFS at the time of the primary analysis.
Measure: DFS rate at 2, 3 and 5 years assessed by IRC Time: From the time of randomization to recurrence of tumor or death, approximately 6 years.Description: OS is deļ¬ned as the time from randomization to death due to any cause. The survival will be followed up with telephone every 24 weeks after discontinuation of the randomized treatment.
Measure: OS (Overall survival) Time: The time from randomization to death due to any cause, approximately 8 years.Description: OS rate at 5 years is defined as the proportion of patients alive at 5 years.
Measure: OS rate at 5 years Time: The time from randomization to death due to any cause, approximately 8 years.Description: AEs are graded according to CTCAE v5.0 and recorded in the case report form.
Measure: Incidence and severity of adverse events (AEs) Time: From the screening period to 28 days after treatment completion, approximately 4 years.Description: Defined as the pharmacokinetics exposure parameters derived from plasma concentrations of Almonertinib and its metabolite, HAS-719.
Measure: Plasma concentrations of Almonertinib and HAS-719 metabolite. Time: From Cycle 3 (Each cycle =3 weeks) to Cycle 4, approximately 3 weeks.Allocation: Randomized
Parallel Assignment
There are 2 SNPs
7. Confirmation by the central laboratory that the tumor harbors one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations including T790M. --- L858R ---
7. Confirmation by the central laboratory that the tumor harbors one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations including T790M. --- L858R --- --- T790M ---