Evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of FH-006 in combination with other anti-tumor treatments in lung cancer subjects, and determine the recommended dose (RP2D) and initial efficacy for phase II clinical trials.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
FH-006 ; SHR-1316 ; BP102 ; Cisplatin ; Carboplatin
FH-006 ; SHR-1316 ; BP102
FH-006; SHR-1316 ; SHR-8068
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGDLT (Dose-limiting toxicity):Severe toxicity occurred 21 or 28 days after each subject received their first systemic anticancer treatment.
Time frame: 21or28 days after the first administration of each subject
Incidence of Treatment-Emergent Adverse Events
Time frame: from first dose to disease progression or death, up to 3 years.
RP2D (Recommended Phase II Dose):This was determined through a comprehensive evaluation of safety data and pharmacokinetic characteristics.
This was determined through a comprehensive evaluation of safety data and pharmacokinetic characteristics.
Time frame: from first dose to disease progression or death, up to 3 years
ORR (Objective Response Rate)
The proportion of patients whose tumor volume shrank to the pre-defined standard (complete or partial response) after treatment.
Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years
Duration of response (DoR)
Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years
disease control rate (DCR)
Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years
progression free survival (PFS)
Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years
overall survival (OS)
Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years
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