Efficacy-Safety-Immunogenicity Study of CBT124&EU-sourced Avastin® in Stage 4 NSCLC

• Status: Unknown status
• Trial end date: 2018-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cipla BioTec Pvt. Ltd.
• Treatments: Albumin-Bound Paclitaxel; Bevacizumab; Carboplatin; Paclitaxel

Criteria

Inclusion Criteria: Subjects may be entered in the study only if they meet all of the following criteria:

• 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.

Exclusion Criteria: Subjects will not be entered in the study for any of the following reasons:

• 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 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

• 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 enrollment.