This is a Phase 3, randomized, positive-controlled, open-label clinical study. The primary objective is to evaluate the efficacy of JMT101 in combination with osimertinib versus osimertinib alone in patients with newly diagnosed locally advanced or metastatic non-squamous NSCLC harboring EGFR-sensitive mutations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
516
JMT101 is a recombinant humanized anti-EGFR monoclonal antibody.
EGFR TKI
Sun Yat sen University Cancer Prevention and Treatment Center
Guangzhou, China
RECRUITINGPFS assessed by the independent review committee (IRC) based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Time frame: Up to approximately 44 months after the first participant is enrolled
Overall survival (OS)
Time frame: Up to approximately 44 months after the first participant is enrolled
Objective response rate (ORR) assessed by IRC based on RECIST 1.1
Time frame: Up to approximately 44 months after the first participant is enrolled
duration of response (DOR) assessed by IRC based on RECIST 1.1
Time frame: Up to approximately 44 months after the first participant is enrolled
disease control rate (DCR) assessed by IRC based on RECIST 1.1
Time frame: Up to approximately 44 months after the first participant is enrolled
DOR assessed by the investigator based on RECIST 1.1
Time frame: Up to approximately 44 months after the first participant is enrolled
ORR assessed by the investigator based on RECIST 1.1
Time frame: Up to approximately 44 months after the first participant is enrolled
DCR assessed by the investigator based on RECIST 1.1
Time frame: Up to approximately 44 months after the first participant is enrolled
Adverse events incidence and severity
Time frame: Up to approximately 44 months after the first participant is enrolled
Serum concentration of JMT101
Time frame: Up to approximately 44 months after the first participant is enrolled
Incidence and titer of anti-drug antibodies (ADAs)
Time frame: Up to approximately 44 months after the first participant is enrolled
The incidence of neutralising antibodies (NAbs)
Time frame: Up to approximately 44 months after the first participant is enrolled
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