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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will be conducted every 6±1 weeks until the disease progresses, new anti-tumor therapy is started, and the study is withdrawn or At the end of the study, the serum of Endo will be collected in different expected ways to evaluate the pharmacokinetic characteristics; Adverse events were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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endostar pump for three days | Experimental | Group A: The first cycle, Endostar 7.5mg/m2/day, intravenous infusion for 4 hours, D1-14 First 2-4 cycles, Endo 105mg/m2/cycle D1 starts intravenous pump for 72 hours; |
|
| Endostar pump for seven days | Experimental | Group B: Cycle 1, Endo 7.5mg/m2/day, intravenous infusion for 4 hours, D1-14 First 2-4 cycles, Endo 105mg/m2/cycle D1 starts intravenous pump injection for 168 hours; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endostar | Drug | This product combined with other combined chemotherapeutics is used to treat patients with stage III/IV NSCLC who are newly treated or relapsed |
|
| Measure | Description | Time Frame |
|---|---|---|
| peak time (Tmax) | pharmacokinetic parameters | At the end of the second cycle, each cycle is 21 days |
| peak concentration (Cmax) | pharmacokinetic parameters | At the end of the second cycle, each cycle is 21 days |
| area under curve (AUC, Including AUC0-t, AUC0-∞) | pharmacokinetic parameters | At the end of the second cycle, each cycle is 21 days |
| terminal elimination half-life (T1/2) | pharmacokinetic parameters | At the end of the second cycle, each cycle is 21 days |
| steady-state minimum blood concentration (CSS min) | pharmacokinetic parameters | At the end of the second cycle, each cycle is 21 days |
| mean steady-state blood concentration (CSS AV) | pharmacokinetic parameters | At the end of the second cycle, each cycle is 21 days |
| accumulation coefficient (RAC) | pharmacokinetic parameters | At the end of the second cycle, each cycle is 21 days |
| mean residence time (MRT) | pharmacokinetic parameters |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AE) incidence | Adverse event (AE) incidence | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| The objective response rate (ORR) | The investigator evaluated the objective response rate (ORR), based on the RECIST 1.1 standard | through study completion, an average of 1 year |
| disease control rate (DCR) |
Inclusion Criteria:
System Laboratory Inspection Standard hematology Absolute neutrophil count >1.5 ×109/L Platelet >100×109/L Hemoglobin >90g/L kidney Serum creatinine or Creatinine clearance rate (CrCl) or glomerular filtration rate (GFR) (Cockcroft-Gault formula) <1.5 × ULN or >60 mL/min1.73m2 (for patients with creatinine level ≥ 1.5 × ULN) liver Total bilirubin (serum) <2.5 × ULN or Direct bilirubin <ULN (for patients with total bilirubin level ≥ 1.5×ULN) AST and ALT <2.5 × ULN or ≤5 × ULN (for patients with liver metastases) Blood clotting International normalized ratio (INR) or prothrombin time (PT) <1.5 × ULN, unless the patient is receiving anticoagulation therapy
Urine routine Urine protein ≤+ (For patients with urine protein ≥++, 24-hour urine protein quantification is required, and 24-hour urine protein needs to be less than 1g)
· Women of childbearing age during the screening period had negative blood pregnancy test results. The patient agrees to self-sign and know Consent to use reliable contraceptive methods within 90 days after the end of treatment.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| qingxia fan | Contact | 13939039058 | fqx2243@126.com | |
| wei he | Contact | 18638553286 |
| Name | Affiliation | Role |
|---|---|---|
| xiaojian zhang | the director of the IRB | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lan Mu | Shanghai | Shanghai Municipality | 210000 | China |
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|
| use the vein pump to pump drugs | Device | 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 | Combination Product | Combination therapy with chemotherapy drugs was used |
|
| At the end of the second cycle, each cycle is 21 days |
| apparent volume of distribution (VD) | pharmacokinetic parameters | At the end of the second cycle, each cycle is 21 days |
| clearance rate (CL) | pharmacokinetic parameters | At the end of the second cycle, each cycle is 21 days |
The investigator evaluated the disease control rate (DCR), based on the RECIST 1.1 standard
| through study completion, an average of 1 year |
| the progression-free survival | The investigator evaluated the progression-free survival based on the RECIST 1.1 standard | through study completion, an average of 1 year |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C522911 | endostar protein |
| D043169 | Endostatins |
| D003131 | Combined Modality Therapy |
| ID | Term |
|---|---|
| D043165 | Angiostatic Proteins |
| D042501 | Angiogenic Proteins |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D043170 | Collagen Type XVIII |
| D024041 | Non-Fibrillar Collagens |
| D003094 | Collagen |
| D016326 | Extracellular Matrix Proteins |
| D012596 | Scleroproteins |
| D001685 | Biological Factors |
| D013812 | Therapeutics |
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