Evaluate the efficacy and safety of RC108 in combination with Furmonertinib against Furmonertinib for treatment of EGFR mutation combined with MET-positive unresectable locally advanced or recurrent metastatic NSCLC
Primary objective: Evaluate the efficacy and safety of RC108 in combination with Furmonertinib against Furmonertinib for treatment of EGFR mutation combined with MET-positive unresectable locally advanced or recurrent metastatic NSCLC Secondary objective: Evaluate the pharmacokinetic and immunogenicity characteristics of RC108 in combination with Furmonertinib
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
RC108 in Combination With Furmonertinib
Furmonertinib
Objective Response Rate (ORR)
Investigator-assessed ORR
Time frame: 24 months
Progression-free survival (PFS)
Investigator-assessed PFS
Time frame: 24 months
Disease Control Rate (DCR)
Investigator-assessed DCR
Time frame: 24 months
Duration of Response (DoR)
Investigator-assessed DoR
Time frame: 24 months
Overall survival (OS)
Investigator-assessed OS
Time frame: 45 months
Number of participants with adverse events (AEs)
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: 24 months
Incidence of RC108 anti-drug antibody (ADA)
Incidence, occurrence time and ADA titer of positive RC108 ADA and neutralizing antibodies
Time frame: 24 months
Pharmacokinetic profile of RC108
Peak and trough concentrations of RC108 total antibody (TAb), conjugated antibody (ADC), free MMAE
Time frame: 24 months
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Beijing Chest Hospital,Capital Medical Unniversity
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