An Open-label, Multicenter, Randomized, Phase 2 Study of a Recombinant Human Anti-VEGFR-2 Monoclonal Antibody, IMC-1121B in Combination with Platinum-based Chemotherapy versus Platinum-based Chemotherapy Alone as First-line Treatment of Patients with Recurrent or Advanced Non-small Cell Lung Cancer (NSCLC)

ImClone LLC0 个研究点目标入组 280 人开始时间: 2010年6月30日最近更新: 2018年5月14日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: ImClone LLC
入组人数: 280

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•1. The patient has histologically or cytologically confirmed NSCLC. Mixed NSCLC
•tumors will be categorized by the predominant cell type. NSCLC tumors that are not
•otherwise specified (NOS) with regard to histology or cannot be sub-classified as
•squamous, adenocarcinoma, or large cell histology, will be categorized as nonsquamous. Primary or metastatic site may be used for histology. For squamous cell histology or for centrally located mediastinal masses (< 30 mm from the carina) identified by computed tomography scan (CT) or chest X-ray, the patient must undergo a magnetic resonance imaging (MRI) of the chest or I.V. contrast CT scan within 4 weeks of anticipated study entry, to exclude major airway or blood vessel invasion by cancer or intratumor cavitation.
•2. The patient has Stage IV NSCLC disease at the time of study entry (based on the American Joint Committee on Cancer [AJCC], 7th ed).
•3. The patient has measurable disease at the time of study entry as defined by the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
•4. The patient has resolution to Grade = 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03, of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy (with the exception of alopecia).
•5. The patient has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-1.
•6. The patient has adequate hematologic function as defined by an absolute neutrophil count (ANC) = 1500/µL (= 1.5 × 10exp9/L), hemoglobin = 9.5 g/dL (= 5.95 mmol/L), and a platelet count = 100,000/µL (= 100 × 10exp9/L) obtained within 2 weeks prior to randomization.
•7. The patient has adequate hepatic function as defined by a total bilirubin = 1.5 mg/dL (25.7 µmol/L) (except for known Gilbert’s disease) and alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) = 5 x the upper limit of normal (ULN) in the presence of liver metastases or = 2.5 x the ULN in the absence of liver metastases obtained, within 2 weeks prior to randomization.
•The patient does not have:
•- cirrhosis at a level of Child-Pugh B (or worse) or
•- cirrhosis (any degree) and a history of hepatic encephalopathy or clinically
•meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined
•as ascites resulting from cirrhosis and requiring ongoing treatment with diuretics
•and/or paracentesis.
•8. The patient has adequate renal function as defined by calculated creatinine clearance (CrCl) = 45 mL/min based on the original, weight-based Cockcroft and Gault formula, and urine dipstick or routine urinalysis for protein < 1+ (ie, either 0 or trace) obtained within 2 weeks prior to randomization. If urine dipstick is = 1+, a 24-hour urine for protein must demonstrate < 500 mg of protein 24 hours to allow participation in the study.
•9. The patient has adequate coagulation function as defined by international normalized ratio (INR) = 1.5 and a partial thromboplastin time (PTT) = 5 seconds above ULN if not receiving anticoagulation therapy. Patients on full-dose anticoagulation must be on a stable dose of oral anticoagulant or low molecular weight heparin, and if on warfarin must have therapeutic INR and have no active bleeding (14 days prior to randomization) or pathological condition that carries a high risk of bleeding (eg, tumor involving major vessels or known varices).
•10. The patient, if sexually ac

排除标准

•1. The patient’s tumor wholly or partially contains small cell lung cancer.
•2. The patient has untreated central nervous system (CNS) metastases. Patients are eligible if they are clinically stable with regard to neurologic function, off all steroids after cranial irradiation (whole brain radiation therapy, focal radiation therapy, stereotactic radiosurgery) ending at least 2 weeks prior to randomization, or after surgical resection performed at least 4 weeks prior to randomization.
•3. The patient has a concurrent active malignancy other than adequately treated basal cell carcinoma of the skin or preinvasive carcinoma of the cervix. A patient with previous history of malignancy other than NSCLC is eligible, provided that he/she has been free of disease for = 3 years.
•4. The patient has received prior therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies targeting VEGF or VEGFR.
•5. The patient is receiving concurrent treatment with other anticancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, radiotherapy, chemoembolization, or targeted therapy.
•6. The patient has received previous chemotherapy for Stage IV NSCLC (patients who have received adjuvant chemotherapy are eligible if the last administration of the prior adjuvant regimen occurred at least 6 months prior to randomization).
•7. The patient has radiologically documented evidence of major blood vessel invasion or encasement by cancer.
•8. Regardless of tumor histology, the patient has radiographic evidence of intratumor
•cavitation.
•9. The patient has undergone chest irradiation within 12 weeks prior to randomization (except palliative irradiation of bone lesions, which is allowed; in the case of focal or palliative radiation treatment to bone, at least 7 days must have elapsed from last radiation treatment prior to randomization provided that 25% or less of total bone marrow had been irradiated).
•10. The patient has an ongoing or active clinically significant infection (infection requiring antibiotics), including active tuberculosis or known infection with the human immunodeficiency virus.
•11. The patient has a history of significant neurological or psychiatric disorders, including dementia, seizures, or bipolar disorder, potentially precluding protocol compliance.
•12. The patient has experienced clinically relevant coronary artery disease, myocardial infarction within 6 months prior to randomization, uncontrolled congestive heart failure, or symptomatic poorly controlled arrhythmia.
•13. The patient has poorly-controlled hypertension (ie, blood pressure in abnormal range despite medical management).
•14. The patient has superior vena cava syndrome contraindicating hydration.
•15. The patient has clinically significant third space fluid collections; for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to Day 1 of Cycle 1.
•16. The patient has experienced any Grade 3-4 gastrointestinal bleeding within 3 months prior to study entry.
•17. The patient has uncontrolled thrombotic or hemorrhagic disorders.
•18. The patient is receiving chronic daily treatment with aspirin (> 325 mg/day) or other known inhibitors of platelet function including, but not limited to clopidogrel.
•19. Patients with a history of gross hemoptysis (defined as bright red blood or
•= 1/2 teaspoon) within 2 months of entry into this trial.
•20. The patient has had a serious nonhealing wound, ulcer, or bone fracture

研究者

发起方

ImClone LLC

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