This trial is an open-label, randomized, multicenter study to explore Endostar in combination with standard platinum-based chemotherapy with different methods in patients with advanced/metastatic non-small cell lung cancer (NSCLC)
Patients in group A received a standard 21-day treatment cycle of platinum-containing two-drug chemotherapy and endurance treatment. Yep The first cycle of the degree of use is 7.5mg/m2/day intravenous infusion for 4 hours (referred to as the time window of 4h 20min From the 1st day to the 14th day (D1-14 Endo cycle 2-4 uses 105mg/m2/cycle From the first day, continuous intravenous pump injection for 72 hours (the set time window is 72h±2h.). Patients in group B received a standard 21-day treatment cycle of platinum-containing two-drug chemotherapy and endurance treatment. Yep The first cycle of the degree of use is 7.5mg/m2/day intravenous infusion for 4 hours (referred to as the time window is 4h±20min From the 1st day to the 14th day (D1-14 Endo cycle 2-4 is used 105mg/m2/cycle From the first day, continuous intravenous pump injection for 168 hours (set time window is 168h±2h). Endostar and chemotherapy drugs are used for 4 cycles. Research will Use RECIST 1.1 standard to evaluate in progress and after enrollment Efficacy assessment will be conducted every 6±1 weeks until the disease progresses, new anti-tumor therapy is started, and the study is withdrawn or At the end of the study, the serum of Endo will be collected in different expected ways to evaluate the pharmacokinetic characteristics; Adverse events were evaluated according to CTCAE5.0 standards. The start time of the test is The first fine was when the informed consent form was signed. The end of the test is the last The subject completed 24 weeks after the first treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
24
This product combined with other combined chemotherapeutics is used to treat patients with stage III/IV NSCLC who are newly treated or relapsed
During the first 14 days of the first cycle, the experimental drug was pumped daily with an intravenous pump. During cycles 2-4, subjects in group A were pumped with experimental drugs for 3 days and subjects in group B were pumped with experimental drugs for 7 days.
Combination therapy with chemotherapy drugs was used
Lan Mu
Shanghai, Shanghai Municipality, China
peak time (Tmax)
pharmacokinetic parameters
Time frame: At the end of the second cycle, each cycle is 21 days
peak concentration (Cmax)
pharmacokinetic parameters
Time frame: At the end of the second cycle, each cycle is 21 days
area under curve (AUC, Including AUC0-t, AUC0-∞)
pharmacokinetic parameters
Time frame: At the end of the second cycle, each cycle is 21 days
terminal elimination half-life (T1/2)
pharmacokinetic parameters
Time frame: At the end of the second cycle, each cycle is 21 days
steady-state minimum blood concentration (CSS min)
pharmacokinetic parameters
Time frame: At the end of the second cycle, each cycle is 21 days
mean steady-state blood concentration (CSS AV)
pharmacokinetic parameters
Time frame: At the end of the second cycle, each cycle is 21 days
accumulation coefficient (RAC)
pharmacokinetic parameters
Time frame: At the end of the second cycle, each cycle is 21 days
mean residence time (MRT)
pharmacokinetic parameters
Time frame: At the end of the second cycle, each cycle is 21 days
apparent volume of distribution (VD)
pharmacokinetic parameters
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Time frame: At the end of the second cycle, each cycle is 21 days
clearance rate (CL)
pharmacokinetic parameters
Time frame: At the end of the second cycle, each cycle is 21 days
Adverse events (AE) incidence
Adverse event (AE) incidence
Time frame: through study completion, an average of 1 year