This is a randomized, open-Label, multicenter, Phase III study.
Name: HS-10296
Name: Gefitinib
Description: To assess the efficacy of HS-10296 compared with gefitinib as first line therapy to EGFRm+, locally advanced or metastatic NSCLC patients by assessment of progression free survival (PFS) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Measure: Assess the efficacy of HS-10296: progression free survival (PFS) Time: From baseline, then every 6 weeks, until disease progression or discontinuation from study. From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.Description: Overall survival (OS)
Measure: Assess the anti-tumor activity: OS Time: Start of study drug to Survival Endpoint through study completion, an average of 3 years.Description: Objective response rate (ORR)
Measure: Assess the anti-tumor activity: ORR Time: From baseline, then every 6 weeks, until disease progression or discontinuation from study. ORR is defined as the percentage of patients who have at least 1 response of CR or PR prior to any evidence of progression assessed up to 24 months.Description: Duration of response (DoR)
Measure: Assess the anti-tumor activity: DoR Time: 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 assessed up to 24 months.Description: Disease control rate (DCR)
Measure: Assess the anti-tumor activity: DCR Time: From baseline, then every 6 weeks, until disease progression or discontinuation from study. The DCR is defined as the proportion of patients with a best overall response of CR, PR, or SD assessed up to 24 months.Description: Depth of response (DepOR)
Measure: Assess the anti-tumor activity: DepOR Time: From baseline, then every 6 weeks, until disease progression or discontinuation from study. DepOR is defined as the sum of the lengths of the longest diameters of the RECIST 1.1 target lesions up to 24 months.Description: Number of adverse events (AEs)/serious adverse events (SAEs)
Measure: Assess the safety of HS-10296: Number of AEs/SAEs Time: Continuously throughout the study until 28 days after HS-10296 discontinuationDescription: Incidence and severity of AEs/SAEs assessed by CTCAE v4.03
Measure: Assess the safety of HS-10296: Incidence and severity of AEs/SAEs Time: Continuously throughout the study until 28 days after HS-10296 discontinuationDescription: Dose interruptions
Measure: Assess the safety of HS-10296: Number of Participants with Dose interruptions Time: Continuously throughout the study until 28 days after HS-10296 discontinuation.Description: Dose reductions
Measure: Assess the safety of HS-10296: Number of Participants with Dose reductions Time: Continuously throughout the study until 28 days after HS-10296 discontinuation.Allocation: Randomized
Parallel Assignment
There is one SNP
4. The tumour harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either or in combination with other EGFR mutations assessed by central testing using tumour tissue sample or blood sample. --- L858R ---