This is an open label, multi-center, multiple dose Phase IB/II study to evaluate the safety, tolerability and efficacy of SHR-1826 for injection in subjects with NSCLC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
400
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGRecommended phase II dose (RP2D)
Time frame: Screening up to study completion, an average of 1 year.
Adverse events (AEs)
Time frame: Screening up to study completion, an average of 1 year.
Objective response rate (ORR)
Time frame: Screening up to study completion, an average of 1 year.
Disease control rate (DCR)
Time frame: Screening up to study completion, an average of 1 year.
Duration of response (DoR)
Time frame: Screening up to study completion, an average of 1 year.
Progression-free survival (PFS)
Time frame: Screening up to study completion, an average of 1 year.
Overall survival (OS)
Time frame: Screening up to study completion, an average of 1 year.
Drug resistant antibody (ADA) to SHR-1826
Time frame: Screening up to study completion, an average of 1 year.
Blood concentration of SHR-1826
Time frame: Screening up to study completion, an average of 1 year.
Blood concentration of free toxin
Time frame: Screening up to study completion, an average of 1 year.
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SHR-8068 for injection.
Ametinib mesylate.
BP-102 for injection.
Carboplatin for injection.