The study is being conducted to evaluate the efficacy, safety, and ORR of HRS-4508 combined with other antitumor therapies in subjects with locally advanced or metastatic non-small cell lung cancer; Evaluate the pharmacokinetic (PK) characteristics of HRS-4508 and other efficacy endpoints for the treatment of locally advanced or metastatic non-small cell lung cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
PartA :HRS-4508 tablet fixed dose+SHR-A1811 fixed dose PartB:HRS-4508 tablet fixed dose + Adebrelimab Injection fixed dose PartC:HRS-4508 tablet fixed dose +SHR-A1811 fixed dose + Adebrelimab Injection fixed dose
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGZhejiang Tumor Hospital
Hangzhou, Zhejiang, China
RECRUITINGDose limiting toxicity (DLT)
Time frame: 2 month
Maximum tolerated dose (MTD)
Time frame: 2 month
Determine dose recommendation (RP2D)
Time frame: 6month
The incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0)
Time frame: 1 years
Objective response rate (ORR)
Time frame: 1 year
Blood concentrations of HRS-4508 and SHR-A1811
Time frame: 12 weeks
Duration of response (DoR)
Time frame: 1 year
Disease control rate (DCR)
Time frame: 1 year
Progression free survival (PFS)
Time frame: 1 year
Overall survival (OS)
Time frame: 2 year
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