The objective of this study is to assess the efficacy, safety of MRG003 as single agent in EGFR-positive advanced non-small cell lung cancer
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
87
Administered intravenously
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Objective Response Rate (ORR) by Investigator
ORR is defined as the proportions of patients with a complete response (CR) and partial response (PR). ORR will be assessed by investigator according to RECIST v1.1.
Time frame: Baseline to study completion, up to 12 months
Progression Free Survival (PFS)
PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause.
Time frame: Baseline to study completion, up to 12 months
Duration of Response (DoR)
DOR is defined as the duration from the initial recording of objective disease response to the first onset of tumor progression, or death of any cause.
Time frame: Baseline to study completion, up to 12 months
Time to Response (TTR)
TTR is defined as the duration from the start of treatment to the first onset of CR or PR in tumor evaluation.
Time frame: Baseline to study completion, up to 12 months
Disease Control Rate (DCR)
DCR is defined as the proportions of patients achieving CR, PR, and stable disease (SD) after treatment.
Time frame: Baseline to study completion, up to 12 months
Overall Survival (OS)
OS is defined as the duration from the start of treatment to death of any cause.
Time frame: Baseline to study completion, up to 12 months
Adverse Events (AEs)
Any reaction, side effect, or untoward event that occurs during the course of the clinical trial whether or not the event is considered related to the study drug.
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Time frame: Baseline to 60 days after the last dose of study treatment