To assess the efficacy and safety of Aumolertinib plus chemotherapy versus Aumolertinib alone as first-line treatment in locally advanced or metastatic non-small cell lung cancer (NSCLC) with sensitizing epidermal growth factor receptor mutations (EGFRm+).
HS-10296-306 is a randomized, open-label, multicenter, phase III study to assess the efficacy and safety of Aumolertinib plus chemotherapy versus Aumolertinib alone as first-line treatment in locally advanced or metastatic non-small cell lung cancer (NSCLC) with sensitizing epidermal growth factor receptor mutations (EGFRm+). Eligible patients are randomized to receive either Aumolertinib (110 mg orally, once daily) in combination with platinum-based chemotherapy (every 3 weeks for 4\~6 cycles) or Aumolertinib (110 mg orally, once daily) in a 1:1 ratio.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
624
Aumolertinib 110 mg QD in combination with pemetrexed (500 mg/m2) plus cisplatin (75 mg/m2) or carboplatin (AUC5) on Day 1 of every 21-day cycles up to 4\~6 cycles, followed by Aumolertinib 100mg QD with pemetrexed maintenance (500 mg/m2) on Day 1 of every 21-day cycles. Dose may be reduced to allow for the management of investigational drug related toxicity.
Placebo Aumolertinib 110 mg QD Dose may be reduced to allow for the management of investigational drug related toxicity.
Shanghai Chest Hospital
Shanghai, Shanghai Chest Hospital, China
PFS (Progression Free Survival) assessed by IRC (Independent Review Committee)
IRC-PFS is defined as the time from randomization until the date of objective disease progression based on IRC assessment or death (by any cause in the absence of progression). The patients will receive long-term follow-up including chest and abdominal CT every 6 weeks until Week 18, then every 12 weeks and onwards.
Time frame: From the time of randomization to disease progression or death, approximately 3 years.
ORR (Objective Response Rate) assessed by IRC (Independent Review Committee)
ORR is defined as the percentage of patients who have at least 1 response of CR or PR prior to any evidence of progression.
Time frame: From the time of randomization to the date of first occurrence of complete response (CR) or partial response (PR), approximately 3 years.
DoR (Duration of response)
DoR is defined as the time from the date of first documented response until the date of documented progression or death in the absence of disease progression.
Time frame: From the time of randomization to disease progression or death, approximately 3 years.
DCR (Disease Control Rate)
The DCR is defined as the proportion of patients with a best overall response of CR, PR, or SD.
Time frame: From the time of randomization to disease progression or death, approximately 3 years.
DepOR (Depth of Response)
DepOR is defined as the sum of the lengths of the longest diameters of the RECIST 1.1 target lesions.
Time frame: From the time of randomization to disease progression or death, approximately 3 years.
PFS (Progression Free Survival) Rate at 12, 18, 24, and 36 months
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PFS Rate at 12, 18, 24, and 36 months is defined as proportion of progression free survival at 12, 18, 24, and 36 months from the date of randomization.
Time frame: The PFS Rate at 12, 18, 24, and 36 months is assessed up to 36 months.
OS (Overall survival)
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 12 weeks after discontinuation of the randomized treatment.
Time frame: From the time of randomization to death due to any cause, approximately 6 years.
OS (Overall survival) rate at 3, 5 years
OS rate at 3, 5 years is defined as the proportion of patients alive at 3, 5 years from the date of randomization.
Time frame: The OS rate at 3, 5 years is assessed up to 5 years.
Incidence and severity of AEs (Adverse Events)
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.