CTRI/2017/02/007805尚未招募3 期
A Randomized, Double-blind, Multicentric,Parallel-group Study Comparing Efficacy, Safety andImmunogenicity of CBT124, a Candidate BiosimilarBevacizumab in Combination with Carboplatin andPaclitaxel with EU-sourced Avastin® in Combinationwith Carboplatin and Paclitaxel in First-line Treatmentfor Subjects with Stage IV (Unresectable RecurrentDisease or Metastatic) Non-squamous Non-Small CellLung Cancer (NSCLC)
Cipla BioTec Pvt Ltd21 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年2月20日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 21
- 主要终点
- Objective Response Rate (ORR) per RECIST criteria version 1.1.Objective response rate is defined as the proportion of subjects whose best confirmed overall
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult subjects aged ≥ 18 to 75 years (≥ 18 to 65 years for India) with histologically or cytologically confirmed advanced non-squamous NSCLC.
- •Mixed tumors should be categorized according to the predominant histology
- •Epidermal growth factor receptor (EGFR) negative (for example, deletion exon 19 or exon 21 point mutation L858R) or wild type mutations
- •No Kirsten rat sarcoma viral oncogene homolog (KRAS) and anaplastic lymphoma receptor tyrosine kinase (ALK) positive subjects
- •Stage IV (Unresectable recurrent disease or metastatic) NSCLC
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or
- •Evaluable disease status or measurable tumor
- •Life expectancy > 6 months.
- •Adequate hepatic, renal, and bone marrow function (alanine aminotransferase [ALT] and aspartate aminotransferase [AST] < 2.5 × upper limit of normal [ULN], or ALT and AST < 5 × ULN, if liver function abnormalities are due to underlying malignancy; total bilirubin ≤ 1.5 × ULN; serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance ≥ 60 mL/min; urine dipstick < 1+ [i.e., 0 or traces]; international normalized ratio (INR) ≤ 1.5, and partial thromboplastin time ≤ ULN; absolute neutrophil count ≥ 1500/mm3; platelet count ≥ 105/mm3; hemoglobin ≥ 9 g/dL).
- •Subjects with a 1+ or greater urine dipstick reading should undergo further assessment as per the clinical judgement of the Investigator, including 24 hours urine collection or a laboratory protein/creatinine index in urine (with quantitative protein determination in a full sized sample even if not necessarily a 24 hours collection), as needed.
- •Urinary protein should be < 100 mg/24 hours or protein/creatinine index of less than 0.2 mg/mgCreatinine or 15 mg/mmol Creatinine.
- •Subjects with pre-existing hypertension must be well controlled on a stable regimen of antihypertensive therapy.
- •Have systolic blood pressure ≤ 140 and ≥ 90 mmHg, diastolic blood pressure ≤ 90 and ≥ 50 mmHg and heart rate ≥ 40 and ≤ 90 bpm at screening and admission.
- •For single measurements in the 141 to 160 mmHg range (systolic) or in the 91 to 100 mmHg range (diastolic), a single repetition after resting for a few minutes (e.g. 5 minutes) on a supine position on the same day is allowed and, in this case, the mean of both measurements will guide eligibility.
- •The mean of both the measurements should be ≤ 140 mmHg (systolic) and ≤ 90 mmHg (diastolic).
- •Ability to understand risks of participation in the study and willingness provide informed consent.
排除标准
- •Small cell lung cancer (SCLC) or combination of SCLC and NSCLC.
- •Squamous-cell tumors and mixed adenosquamous carcinomas of predominantly squamous nature
- •Known sensitizing EGFR mutations (for example, deletion exon 19 or exon 21 point-mutation L858R) or EML4-ALK translocation-positive mutations.
- •Subjects with KRAS mutations
- •Prior therapy with monoclonal antibodies or small molecule inhibitors against VEGF or VEGF receptors, including bevacizumab
- •Prior therapy with carboplatin or paclitaxel
- •Prior systemic therapy for metastatic disease.
- •Prior systemic anticancer therapy or radiotherapy for locally-advanced NSCLC if completed < 12 months prior to screening
- •Evidence of a tumor that compresses or invades major blood vessels or tumor cavitation that in the opinion of the Investigator is likely to bleed
- •Symptomatic brain metastasis (head computed tomography [CT]/magnetic resonance imaging [MRI] is required within 6 weeks of study randomization)
- •Any unresolved toxicity > Common Toxicity Criteria Grade 1 (except alopecia) from previous anticancer therapy (including radiotherapy)
- •History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding.
- •Thrombotic or hemorrhagic event ≤ 6 months prior to screening
- •History of hemoptysis greater than ½ teaspoon of bright red (fresh) blood in the past 4 weeks
- •Subjects receiving long-term aspirin (> 325 mg/day), or other non-steroidal anti-inflammatory agents, or other drugs known to inhibit platelet function, treatment with dipyridamole, ticlopidine, or clopidogrel
- •Subjects receiving anticoagulants
- •Subjects who plan to undergo surgery during the study period
- •Subjects who have undergone a major surgery, or have had a significant traumatic injury within 4 weeks prior to randomization
- •Subjects who have a significant non-healing wound, or bone fracture within 4 weeks prior to randomization
- •Subjects with history of gastrointestinal perforation or fistula formation
- •Female subjects who are pregnant, breast-feeding, planning to be pregnant during the study, or women of child-bearing potential (any woman who is not surgically sterile i.e., bilateral tubal ligation, total hysterectomy or < 2 years post menopause) not using a reliable method of double contraception (e.g. condom plus diaphragm, condom or diaphragm plus spermicidal gel/foam, tubal ligation, or stable dose of hormonal contraception) throughout the study period
- •Male subject with a partner of childbearing potential (as mentioned in exclusion criteria 19) who does not consent to the use of a reliable method of double contraception (as mentioned in exclusion criteria 19)
- •Subjects with uncontrolled hypertension
- •Subjects with active infection assessed to be clinically significant by Investigator
- •Known history of, or positive test result for human immunodeficiency virus (HIV), hepatitis C virus (test for hepatitis C virus antibody [HCVAb]) or hepatitis B virus (test for Hepatitis B surface Antigen [HBsAg])
- •History of alcohol or substance abuse
- •Prior treatment with any investigational drug within the 30 days prior to screening, or within 5 half-lives of the drug, whichever is longer 26.
结局指标
主要结局
Objective Response Rate (ORR) per RECIST criteria version 1.1.Objective response rate is defined as the proportion of subjects whose best confirmed overall
时间窗: 19 Weeks
response over Week 1 to Week 19 is either complete response (CR) or partial response (PR).
时间窗: 19 Weeks
Confirmed best overall response (complete or partial response) may be claimed only if the
时间窗: 19 Weeks
criteria for each are met after a repeat radiologic tumor assessment (using RECIST criteria
时间窗: 19 Weeks
version 1.1) 6 weeks later.
时间窗: 19 Weeks
次要结局
- Efficacy: Progression-free survival (PFS) rate(Overall Survival (OS) rate)
- Pharmacokinetics: Secondary PK parameters(Cycle 1 (Cmax))
- Safety (Proportion of subjects with selected adverse events (AE) of gastrointestinal perforation, hypertension, proteinuria, and pulmonary hemorrhage)(19 weeks and EoS)
研究者
研究点 (21)
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