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临床试验/CTRI/2019/08/020665
CTRI/2019/08/020665Other3 期

A randomized, double-blind, multicentre, multinational comparative clinical study to compare theefficacy and safety of INTP24 against Avastin® in patients with unresectable, locally advanced,recurrent or metastatic non-squamous non-small cell lung cancer.

Intas Pharmaceuticals Ltd Biopharma Division0 个研究点目标入组 32 人开始时间: 待定最近更新:
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试验速览

阶段
3 期
状态
Other
发起方
入组人数
32
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

入排标准

入选标准

  • •1. Patient of either gender and aged greater than or equal to 18 years
  • •2. Patient having histologically or cytological confirmed predominately nonsquamous, non-small cell lung cancer.
  • •3. Patients with locally advanced, unresectable or metastatic non-small cell lung cancer or recurrent non-small cell lung cancer according to The Union for International Cancer Control (UICC) staging system.
  • •4. At-least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 or higher criteria.
  • •5. For patients with recurrent disease, at least 6 months must have elapsed since
  • •completing adjuvant or neoadjuvant treatment
  • •6. ECOG performance status less than or equal to 2.
  • •7. Patient should be eligible to receive study treatment of bevacizumab, paclitaxel, and carboplatin for the treatment of locally advanced or recurrent or metastatic non-squamous NSCLC.
  • •8. Patient must have an adequate bone marrow, renal and hepatic function
  • •9. Women of childbearing potential and partners of sexually active males must agree to use an accepted and effective method of contraception (oral, transdermal, or implanted contraceptives [any hormonal method in conjunction with a
  • •secondary method], intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, / and if males, absolute sexual abstinence, use of condom with spermicide by sexual partner or
  • •temporarily sterile [at least 6 months prior to study drug administration] sexual partner) for the duration of the study and for at least 6 months after the last dose of the study treatment or permanently sterile.
  • •Female patients who are not of childbearing potential should have undergone a documented hysterectomy and/or bilateral oophorectomy or have achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause (status may be confirmed at Investigator discretion by having a serum follicle stimulating hormone (FSH) level)
  • •10. Patients able to understand the investigational nature of this study and give
  • •written informed consent prior to the participation in the trial and able to comply
  • •with study requirement in the opinion of Principal Investigator.

排除标准

  • •1. Patient who has documented evidence of sensitizing epidermal growth factor receptor (EGFR) mutations or EML4-ALK translocation positive mutations.
  • •2. Prior systemic therapy for non-small cell lung cancer (adjuvant or neoadjuvant therapy in case of recurrent disease will be allowed).
  • •3. Prior immunotherapy or bevacizumab therapy.
  • •4. Concurrent treatment with other anticancer therapies (excluding that defined in the protocol). Bone directed therapies like bisphosphonates and denosumab will be allowed.
  • •5. Pregnant and breast-feeding women. Male patients with current pregnant partners will not be eligible.
  • •6. History of local radiation therapy for bone metastases within last 1 month prior to the day of randomization.
  • •7. Patients with a history of gross haemoptysis (defined as bright red blood of 1/2 teaspoon (2.5 ml) or more) or haemorrhage within last 3 months
  • •8. Evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic
  • •Anticoagulation)
  • •9. Current or recent (within 10 days of randomization) use of aspirin (greater than 325 mg/day) or treatment with dipyramidole, ticlopidine, clopidogrel, and cilostazol
  • •10. Current use of oral or parenteral anticoagulants or thrombolytic agents for
  • •therapeutic purposes that has not been stable for greater than 2 weeks prior to randomization
  • •and INR/aPTT is within therapeutic limits (as per the local medical standards)
  • •11. Therapeutic anticoagulation and/or coagulation abnormalities (e.g., INR greater than 1.5 and aPTT greater than ULN unless on prophylactic anticoagulation).
  • •12. Patient with known brain metastases. A CT/MRI brain is required to confirm if it
  • •was not done within 4 weeks prior to study entry.
  • •13. Patients with non-healing wound ulcer, or bone fracture, or major surgical procedure, open biopsy, or significant traumatic injury within last 28 days or anticipation of need for major surgical procedure during the study.
  • •14. Patients with history of gastrointestinal perforation, tracheoesophageal fistula or any grade 4 fistula
  • •15. Patients with clinically significant cardiac diseases like New York Heart Association (NYHA) Grade II or greater, congestive heart failure (multigated acquisition [MUGA] or echocardiogram [ECHO]), unstable angina pectoris, myocardial infarction, cardiac arrhythmia, cerebral infarction, or transient ischemic attacks.
  • •16. Uncontrolled hypertension (systolic blood pressure [BP] greater than 140 or diastolic BP
  • •greater than 90 mmHg) (Patients with hypertension controlled by antihypertensive therapies are eligible).
  • •17. Patients with a prior history of hypertensive crisis and hypertensive encephalopathy
  • •18. Patient with ongoing or active infection (patient should be off anti-infective to be
  • •eligible for participation).
  • •19. A known case of or positive test for human immunodeficiency virus (HIV) infection or hepatitis B or hepatitis C virus (HCV).
  • •20. History of thrombotic events like stroke, active symptomatic peripheral vascular disease within last 6 months.
  • •21. Peripheral motor or sensory neuropathy of grade greater than 2.
  • •22. Known hypersensitivity to any components of the study medications / chemotherapy / supportive medications or its ingredients that can impact treatment.
  • •23. Past or current history of neoplasm other than the entry diagnosis with the except

研究者

发起方
Intas Pharmaceuticals Ltd Biopharma Division

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