The aim of the study is to evaluate the efficacy and safety of SKB264 in combination with osimertinib as first-Line treatment for patients with epidermal growth factor receptor (EGFR) mutations, locally advanced or metastatic non-squamous non-small cell lung cancer.
This is a randomized, open-Label, multicenter, Phase 3 study to evaluate the efficacy and safety of SKB264 in combination with osimertinib versus osimertinib alone as first-line treatment for patients with EGFR mutations, locally advanced or metastatic non-squamous non-small cell lung cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
420
4mg/kg, intravenous (IV) infusion
80mg, QD
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGSun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGProgression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR)
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR or death due to any cause, whichever occurs first.
Time frame: Randomization up to approximately 36 months
Overall Survival (OS)
OS is defined as the time from randomization until the date of death due to any cause.
Time frame: Randomization up to approximately 49 months
Progression-Free Survival (PFS) assessed by Investigator
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator or death due to any cause, whichever occurs first.
Time frame: Randomization up to approximately 36 months
Objective Response Rate (ORR)
ORR is defined as the percentage of patients who achieve complete response(CR) or partial response (PR), as assessed by BICR/investigator per RECIST 1.1
Time frame: Randomization up to approximately 36 months
Disease control rate (DCR)
DCR is defined as the percentage of patients who achieve CR, PR or stable disease (SD), as assessed by BICR/ investigator per RECIST 1.1
Time frame: Randomization up to approximately 36 months
Duration of Response (DoR)
DoR is defined as the time from the date of first documented CR or PR until date of documented disease progression per RECIST 1.1, as assessed by BICR/investigator or death due to any cause, whichever occurs first.
Time frame: Randomization up to approximately 36 months
Time to Response (TTR)
TTR is defined as the time from the date of randomization until the first documentation of CR or PR as assessed by BICR/investigator per RECIST 1.1.
Time frame: Randomization up to approximately 36 months
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