Advanced Non-small Cell Lung Cancer
Conditions
Interventions
experimental group:TRS003 + Paclitaxel + Carboplatin
control group:Bevacizumab + Paclitaxel + Carboplatin
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female, aged >= 18 years. 2. Provision of signed and dated informed consent form. 3. Willing and able to comply with all study procedures. 4. Histologically or cytologically confirmed advanced non-squamous NSCLC, either current metastatic stage IV or local advanced IIIb with previous radiotherapy (defined in the 8th edition of Lung Cancer TNM Classification ) or recurrent non-squamous NSCLC after previous local therapy (if tumor shows multiple etiology, the main cellular phenotype will be classified). 5. No previous therapy targeting the primary tumor or metastatic tumor (whole body chemotherapy, anti-vasculargenesis and molecular target medication). Any adjuvant therapy should be stopped for at least 6 months and there should be no disease progression or recurrence within 6 months after completion of adjuvant therapy. 6. At least one measurable lesion without radiotherapy (Eisenhauer et al.2009). Definition for measurable lesion: the radius can be measured precisely by using any of the following approaches: Enhanced CT, MRI. When scanned with a layer thickness less than5 mm, the radius of lesion outside lymph node should be >= 10 mm, the lymph node lesion should >= 15 mm. 7. ECOG pherformance status(Oken et al.1982) score 0 or 1. 8. Life expectancy >= 6months. 9. Adequate hepatic function as evidenced by meeting all the following requirements: a. Total bilirubin 50 mL/min (Cockroft-Gault Equation) or estimated glomerular filtration rate (GFR) > 50 mL/min. b. Urine dipstick for proteinuria = 1000,000/µl transfusion within 2 weeks prior to the study screening. b. Prothrombin time, international normalized ratio or activated partial thromboplastin time = 1,500/µl without any medical interventional treatment within two weeks prior to the study screening (ie, granulocyte-colony stimulating factors and/or herbal remedies). d. Hemoglobin (Hb) >= 9 g/dl without the need for transfusion within 2 weeks prior to the study screening.
Exclusion criteria
Exclusion criteria: 1. Central squamous lung cancer, mixed small cell and non-small cell lung cancer or squamous cell-dominant adeno-squamous lung cancer. 2. Primacy central nervous system (CNS) malignancy or symptomatic CNS metastases. But clinically controlled, asymptomatic CNS metastases might be eligible if neurologically stable >= 8 weeks following CNS-directed therapy, and no evidence of CNS disease progression >=4 weeks prior to screening as determined by radiographic imaging 3. Concurrent malignancy within 5 years other than adequately treated primary cervic cancer, skin-squamous or basal cell carcinomas, local prostatic cancer with radical resection or ductal carcinoma in situ. 4. NSCLC shows ALK mutation 5. Resistant hypertension (under the treatment with two or more anti-HTN medications, systolic blood pressure >150 mmHg and diastolic blood pressure >100 mmHg at the study screening, or a history of hypertension crisis or hypertensive encephalophy). 6. Cardiac ejection fraction 2.5 mL of red blood, gastrointestinal bleeding, hematemesis, central nervous system hemorrhage, severe epistaxis or vaginal bleeding etc; on anticoagulant including oral or parenteral; on thrombolytic agents (such as low-molecular weight heparin or warfarin and Xa inhibitors); or on aspirin or other nonsteroidal anti-inflammatory drugs that can inhibit platelet within ten days prior to screening. 11. Severe cardiovascular disease, including CVA, TIA, myocardial infarction and significant vascular disease (including but not limited to aneurysm requiring surgical repair or recent artery thrombosis); unstable angina pectoris, NYHA class II heart failure and uncontrollable arrhythmia. 12. Thoracic radiotherapy within 4 weeks prio to screening or palliative radiotherapy for metastasis outside thoracic region within 2 weeks prior to screening. 13. Any major surgical procedure including open-lung biopsy at the risk of bleeding, wound healing complication within 28 days prior to screening, or anticipated elective surgery during the study. 14. Minor surgery such as deep vein catheterization within 48 hours prior to the first dose of the study drugs. 15. Large volume of pericardial or pleural effusion or ascites that can not be controlled by using pumping or other symptomatic treatment but not eligibile to any anti-tumor therapies such as chemotherapy, vascular inhibitors or molecular target drug. 16. Treatment history of monoclonal antibodies or small molecule inhibitors against vascular endothelial growth factor (VEGF) or its receptor (VEGFR), including Bevacizumab. 17. Live or attenuated vaccine within 12 weeks prior to the study screening. 18. History of active gastroduodenal ulcer, abdominal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| DOR;PFS;Immunogenicity;Incidence of adverse events characterized by type, severity, timing, and relationship with study therapy and clinically significant laboratory abnormalities; | — |
Countries
China
Contacts
Public ContactShi Yuankai
Cancer Hospital Chinese Academy of Medical Sciences
Outcome results
None listed