The aim of the study is to evaluate the efficacy and safety of SKB264 in combination with pembrolizumab as firstline treatment for patients with PD-L1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).
This is a randomized, open-label, multicenter, Phase 3 study to evaluate the efficacy and safety of SKB264 in combination with pembrolizumab versus pembrolizumab as firstline treatment for PD-L1 positive patients with locally advanced or metastatic non-small cell lung cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
406
IV Infusion
IV Infusion
Progression 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 22months
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 40 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 22months
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 22months
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 22months
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 22months
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Hebei University Affiliated Hospital
Baoding, China
Beijing Chest Hospital. Capital Medical University
Beijing, China
Beijing Institute for Cancer Research
Beijing, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
Jilin Cancer Hospital
Changchun, China
The First Hospital of Jilin University
Changchun, China
Hunan Cancer Hospital
Changsha, China
The Second People's Hospital of Hunan Province(Brain Hospital of Hunan Province)
Changsha, China
Xiangya Second Hospital of Central South University
Changsha, China
Chengdu Fifth People's Hospital
Chengdu, China
...and 54 more locations
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 22months
Health-Related Quality of Life Assessment
Compare the health-related quality of life (HRQoL) of SKB264 in combination with pembrolizumab and pembrolizumab monotherapy by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) and Quality of Life Questionnaire - Lung Cancer Module 13 (EORTC QLQ-LC13)
Time frame: Randomization up to approximately 22months
AEs and SAEs
Incidence and severity of AEs and SAEs (per CTCAE v5.0), and clinically significant abnormal laboratory results
Time frame: All AEs should be observed and recorded from the first dose until 30 days after the last dose. SAEs were observed and recorded until 90 days after the last dose of pembrolizumab or 30 days after the last dose of SKB264,whichever occurred later.
PK
PK parameters of SKB264-ADC, SKB264-TAB and free KL610023, such as maximum concentration (Cmax), minimum concentration (Cmin ), etc.
Time frame: Randomization up to approximately 22months
Immunogenicity
Immunogenicity test results of SKB264
Time frame: Randomization up to approximately 22months
Biomarkers
Correlation between the expression level of TROP2 in tumor tissues and the efficacy.
Time frame: Tumor tissue samples should be provided for TROP2 testing after subjects are eligible for screening.