EUCTR2014-003878-16-IT进行中（未招募）1 期
A Phase 3 randomized, double-blind study of PF-06439535 plus Paclitaxel-Carboplatin and Bevacizumab plus Paclitaxel-Carboplatin for the first-line treatment of patients with advanced non-squamous non-small cell lung cancer - n.a.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- PFIZER INC
- 入组人数
- 798
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. Male and female patients age =18 years of age, or = age of consent in the region.
- •2. Newly diagnosed Stage IIIB or IV non-small cell lung cancer (according to Revised International System for Staging Lung Cancer criteria of 2010) or recurrent non-small cell lung cancer (NSCLC) for which they had not received chemotherapy for metastatic disease.
- •3. Histologically or cytologically confirmed diagnosis of predominately non-squamous NSCLC.
- •4. At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
- •5. For patients with recurrent disease, at least 6 months must have elapsed since completing adjuvant or neoadjuvant treatment.
- •6. Patients must have had a baseline scan (computed tomography [CT] or magnetic resonance imaging [MRI]) of the chest, abdomen, and other disease sites, as clinically indicated, to assess disease burden performed
- •within 28 days prior to randomization.
- •7. Eastern Cooperative Oncology Group (ECOG) status of 0 or 1.
- •8. Screening laboratory values within the following limits (where deviation of up to 10% is acceptable for any single value if in the investigator's opinion the patient does not have an increased safety risk):
- •Bone Marrow Function
- •a. Absolute neutrophil count (ANC) =1.5 x 10x9 cells/L (1500/mm3);
- •b. Platelet count =100 x 10x9 cells/L (100,000/mm3);
- •c. Hemoglobin =9.0 g/dL (90 g/L);
- •Renal Function
- •d. Serum creatinine =1.5 x upper limit of normal (ULN);
- •e. Urine dipstick proteinuria <2+ (ie, either 0, trace, or 1+). If urine dipstick is >1+ then a 24 hour urine for protein must have demonstrated urinary excretion of =500 mg of protein per day;
- •Liver Function
- •f. Total bilirubin =1.5 x ULN (<3 ULN if Gilbert's disease);
- •g. Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) =3 x ULN (=5 x ULN if liver metastases are present).
- •9. Recovery (to Grade 1 or baseline) from all clinically significant adverse effects of prior therapies (excluding alopecia).
- •10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
- •11. Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •12. Be eligible to receive study treatment of bevacizumab, paclitaxel and carboplatin based on local standard of care, for the treatment of advanced or metastatic non-squamous NSCLC.
- •13. Male and female subjects of childbearing potential and at risk for pregnancy must agree to use two highly effective methods of contraception throughout the study and for at least 6 months after the last dose of assigned treatment (bevacizumab-Pfizer or bevacizumab-EU).
- •Female subjects who are not of childbearing potential (ie, meet at least 1 of the following criteria):
- •Have undergone a documented hysterectomy and/or bilateral oophorectomy;
- •Have medically confirmed ovarian failure; or
- •Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or
- •physiological cause; and have a serum follicle stimulating hormone (FSH) level within the laboratory's reference range for postmenopausal women.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 439
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 359
排除标准
- •1. Small cell lung cancer (SCLC) or combination SCLC and NSCLC. Squamous-cell tumors and mixed adenosquamous carcinomas of predominantly squamous nature.
- •2. Evidence of a tumor that compresses or invades major blood vessels or tumor cavitation.
- •3. Known sensitizing EGFR mutations (for example, deletion 19 or L858R) or EML4-ALK translocation positive mutations.
- •4. History of other cancer within 5 years prior to screening for this study, with the exception of adequately treated ductal carcinoma in situ of the breast, cervical carcinoma in situ, or basal or squamous cell skin cancer.
- •5. Prior systemic therapy for metastatic disease.
- •6. History of hemoptysis (>2.5 mL per event) in the last 3 months or severe bleeding. Evidence of current thrombotic or bleeding disorders. Systemic anticoagulation or chronic therapy with prescription non-steroidal anti-inflammatory drugs (NSAIDs),
- •aspirin >325 mg, or other non-selective NSAIDs above the maximum allowed over the counter (OTC) dose,and/or coagulation abnormalities (eg, INR >1.5 and aPTT greater than ULN within 1 week prior to randomization). [Some NSAIDs have effects on platelet function (see Prescribing Information for the specific NSAID). In the event that a patient’s NSAID therapy exceeds the maximum dose of OTC
- •medication, the investigator should contact the Sponsor for approval of patient inclusion. Approval will be based on the type of NSAID therapy, the dose, and the patient’s other known risk factors.]
研究者
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