This is a multi-center, open-label, phase I study to evaluate the safety, efficacy, pharmacokinetics (PK), and immunogenicity of HS-20122 combined therapy in subjects with locally advanced or metastatic non-small cell lung cancer (NSCLC).
This is a multi-center, open-label, phase I study to evaluate the safety, efficacy, pharmacokinetics (PK), and immunogenicity of HS-20122 combination therapy in subjects with locally advanced or metastatic non-small cell lung cancer (NSCLC). A dose exploration stage of each combination therapy will be conducted in subjects with advanced or metastatic NSCLC patients who experienced disease progression (PD) on or after prior treatments, to explore appropriate doses. In addition, an dose-expansion stage will be conducted in appropriate target populations based on the data obtained in the dose exploration stage to further explore the safe and efficacy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
396
EGFR mut NSCLC, receive HS-20122+Aumolertinib
EGFRwt NSCLC,receive HS-20122+Adbrelimab
EGFR wt NSCLC,receive HS-20122+Adbrelimab+ Platinum-based Chemo
Ethics Committee of Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGRP2D for Combination
To evaluate the potent and tolerated of combination(s) and dosage(s) of HS-20122 based therapy in subjects with locally advanced or metastatic NSCLC who have experienced disease progression on or after prior treatment, which suitable for a Phase II trial
Time frame: Through the full duration of this trial, approximately 2 years
ORR
Investigator evaluated overall response rate, to evaluate the efficacy of each combination;
Time frame: Through the full duration of this trial, approximately 2 years;
TEAE
incidence of Investigator evaluated Treatment Emerged Adverse Events, graded per CTCAE V5.0
Time frame: Through the full duration of this trial, approximately 2 years;
TRAE
incidence of Investigator evaluated Treatment Related Adverse Events, graded per CTCAE V5.0
Time frame: Through the full duration of this trial, approximately 2 years;
SAE
incidence of Investigator evaluated Severe Adverse Events, graded per CTCAE V5.0
Time frame: Through the full duration of this trial, approximately 2 years
Duration of Response
Investigator evaluated Duration of Response
Time frame: Through the full duration of this trial ,approximately 2 years
Disease Control Rate
Investigator evaluated Disease Control Rate
Time frame: Through the full duration of this trial ,approximately 2 years;
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Progression Free Survival
Investigator evaluated duration of Progression Free Survival
Time frame: Through the full duration of this trial, approximately 2 years;
Overall Survival
Investigator evaluated duration of Overall Survival
Time frame: Through the full duration of this trial ,approximately 2 years;
PK parameter
blood concentration of combo agents
Time frame: Through the full duration of this trial, approximately 2 years;
Immuogencity
positive rate of drug specific antibody
Time frame: Through the full duration of this trial ,approximately 2 years;