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.
HS-10296-302 is a randomized, placebo-controlled, double-blind, multicenter, phase III study to assess the efficacy and safety of Almonertinib versus placebo in stage II-IIIB NSCLC with EGFRm+ following complete tumor resection, with or without postoperative adjuvant chemotherapy (2\~4 cycles of platinum-based doublet). Eligible patients are randomized to receive either Almonertinib (110 mg orally, once daily) or placebo (110 mg orally, once daily) in a 1:1 ratio.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
192
The initial dose of Almonertinib 110 mg daily can be reduced to 55 mg daily under specific conditions.
Placebo Almonertinib
Jilin Province Cancer Hospital
Changchun, Jilin, China
DFS (Disease free survival) assessed by IRC (Independent Review Committee)
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.
Time frame: From the time of randomization to recurrence of tumor or death, approximately 4 years.
DFS (Disease free survival) assessed by INVs (Investigators)
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.
Time frame: From the time of randomization to recurrence of tumor or death, approximately 4 years.
DFS rate at 2, 3 and 5 years assessed by IRC
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.
Time frame: From the time of randomization to recurrence of tumor or death, approximately 6 years.
OS (Overall survival)
OS is defined 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.
Time frame: The time from randomization to death due to any cause, approximately 8 years.
OS rate at 5 years
OS rate at 5 years is defined as the proportion of patients alive at 5 years.
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Time frame: The time from randomization to death due to any cause, approximately 8 years.
Incidence and severity of adverse events (AEs)
AEs are graded according to CTCAE v5.0 and recorded in the case report form.
Time frame: From the screening period to 28 days after treatment completion, approximately 4 years.
Plasma concentrations of Almonertinib and HAS-719 metabolite.
Defined as the pharmacokinetics exposure parameters derived from plasma concentrations of Almonertinib and its metabolite, HAS-719.
Time frame: From Cycle 3 (Each cycle =3 weeks) to Cycle 4, approximately 3 weeks.