The Shanghai East Hospital
Shanghai, China
Location status: Recruiting
NCT Number: NCT06980272
This trial is a Phase III study. All patients are stage IIIB/C (unsuitable for radical therapy) or IV non-small cell lung cancer(NSCLC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1. The purpose of this study is to evaluate the efficacy and safety of SSGJ-707 comparing Pembrolizumab in subjects with advanced NSCLC whose tumors have a programmed cell death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) greater than or equal to 1%.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 3
Shanghai, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Subjects receive SSGJ-707 intravenously.
Subjects receive Pembrolizumab intravenously.
Time frame: Up to 2 approximately years
Progression-free survival (PFS) is defined as the time from the date of randomization till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the blinded IRRC or death due to any cause (whichever occurs first).
Time frame: Up to 2 approximately years
Overall Survival (OS) is defined as the time from the start of treatment with SSGJ-707 until death due to any cause.
Time frame: Up to 2 approximately years
ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1.
Time frame: Up to 2 approximately years
Duration of response (DoR) assessed according to RECIST v1.1.
Time frame: Up to 2 approximately years
Disease control rate (DCR) assessed according to RECIST v1.1.
Time frame: Up to 2 approximately years
Time to response (TTR) is defined as the time to response base on RECIST v1.1.
Time frame: Up to 2 approximately years
Progression-free survival (PFS) is defined as the time from the date of randomization till the first documentation of disease progression assessed by the investigator or death due to any cause (whichever occurs first).
Time frame: Up to 2 approximately years
ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1.
Time frame: Up to 2 approximately years
Duration of response (DoR) assessed according to RECIST v1.1.
Time frame: Up to 2 approximately years
Disease control rate (DCR) assessed according to RECIST v1.1.
Time frame: Up to 2 approximately years
Time to response (TTR) is defined as the time to response base on RECIST v1.1.
Time frame: Up to 2 approximately years
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Time frame: Up to 2 approximately years
Number of subjects with detectable anti-drug antibodies (ADA).
Time frame: Up to 2 approximately years
The correlationship between PD-L1 expression and SSGJ-707 anti-tumor activity.
Contact information is provided by the study sponsor or research team.
Shenyang Sunshine Pharmaceutical Co., LTD.
Industry
A Randomized Controlled, Multi-center Phase III Clinical Trial of SSGJ-707 Versus Pembrolizumab as First-line Treatment for PD-L1-Positive Locally-Advanced or Metastatic Non-Small Cell Lung Cancer
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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