The purpose of this study is to determine whether CBT124 and Avastin®are comparable in terms of efficacy, safety, immunogenicity; and whether the pharmacokinetics of CBT124 matches that of Avastin®(pharmacokinetics is nested in this study for Indian patients).
- Conditions
- non-squamous Non-Small-Cell-Lung CancerMedDRA version: 19.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-003301-34-HU
- Lead Sponsor
- Cipla BioTec Pvt. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 200
Adult subjects aged = 18 to 75 years (= 18 to 65 years for India) with histologically or cytologically confirmed advanced non-squamous NSCLC.
•Epidermal growth factor receptor (EGFR) negative or wild type
mutations
•Stage IV (Unresectable recurrent disease or metastatic) NSCLC
•Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
•Evaluable disease status or measurable tumor
•Adequate hepatic, renal, and bone marrow function
•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.
•Ability to understand risks of participation in the study and willingness provide informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
Small cell lung cancer (SCLC) or combination of SCLC and NSCLC.
Squamous-cell tumors and mixed adenosquamous carcinomas of
predominantly squamous nature
•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
•Previous malignancy other than NSCLC in the last 5 years except for basal cell cancer of the skin or pre-invasive cancer of the cervix
•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 nonsteroidal 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
•Subjects with known hypersensitivity to any of the ingredients of the investigational products, or mammalian cell-derived products
•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 who does not consent to the use of a reliable method of double contraception
•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
•Inability to comply with study requirements
•Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the subject unsuitable for enrolment.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The purpose of this study is to determine whether CBT124 and Avastin® are comparable in terms of efficacy, safety, immunogenicity.;Secondary Objective: Whether the pharmacokinetics of CBT124 matches that of Avastin® (pharmacokinetics is tested in this study for Indian patients).;Primary end point(s): Objective Response Rate (ORR);Timepoint(s) of evaluation of this end point: 19 weeks
- Secondary Outcome Measures
Name Time Method