MYL-1402O Compared With Avastin®, in Patients With Stage IV nsNSCLC

Phase 3

Completed

Brief Summary: Assess the Efficacy and Safety of MYL-1402O Compared with Avastin®, in the First-line Treatment of Patients with Stage IV Non-Squamous Non-Small Cell Lung Cancer

Detailed Description: MYL-1402O is a monoclonal antibody currently being developed by Mylan GmbH, as a proposed biosimilar to European Union and US licensed Avastin (hereafter referred to as Avastin), which is approved as first line treatment in combination with carboplatin and paclitaxel (CP) for patients with Stage IV unresectable, recurrent or metastatic nsNSCLC. This randomized equivalence study is designed to meet the global regulatory requirement for approval of a biosimilar product. For this study, both MYL-1402O and Avastin are considered investigational medicinal products (IMP).

Recruitment & Eligibility

Inclusion Criteria

Written and signed informed consent
Male or female at least 18 years of age with documented imaging diagnosis of Stage IV unresectable, recurrent or metastatic nsNSCLC with at least one measurable lesion as defined by RECIST 1.1
Documented histologic or cytologic diagnosis of advanced nsNSCLC with negative or unknown sensitizing epidermal growth factor receptor (EGFR) mutation, and negative or unknown echinoderm microtubule-associated protein like 4 anaplastic lymphoma kinase (EML4 ALK) rearrangement.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Has not received any prior systemic therapy for first-line treatment of advanced lung cancer, except adjuvant chemotherapy, and remained disease-free for at least 12 months from time of surgery, and at least 6 months from last dose of chemotherapy.
Treated and stable brain metastasis.

Key

Exclusion Criteria

Documented squamous NSCLC or small cell type or large cell neuroendocrine histology
History of significant hemoptysis, central tumors with proximity to large vessels and tumor with cavitation
Received prior treatment with paclitaxel, bevacizumab or anthracycline or had known hypersensitivity to any of these components.
Recent significant cardiac condition or vascular event or inadequately controlled hypertension.
On anticoagulant therapy not considered stable
Risk of hemorrhage in the central nervous system
Recent history of surgery, nonhealing wound, active ulcer, or untreated bone fracture.
History of gastrointestinal fistula, perforation, or abscess.

Primary Outcome Measures

Name	Time	Method
Primary Efficacy Analysis of Overall Response Rate ( ORR) of MYL-1402O as Compared to Avastin	18 weeks after first dosing per patient	The primary efficacy endpoint Overall Response Rate (ORR) will be based on best tumor responses as assessed by an independent review at any time point during the first 18 weeks, and assessed according to RECIST 1.1. The primary efficacy analysis is based on the ratio of the MYL-1402O ORR to the Avastin ORR at Week 18 based on the Intent to Treat ( ITT) set of patients.

Secondary Outcome Measures

Name	Time	Method

Locations (101): Grodno Clinical Regional Hospital
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Mogilev, Belarus
Mogilev Regional Oncology Dispensary
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Minsk, Minskaya Voblasts, Belarus
Babruysk Interregional Oncological Dispensary
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Babruysk, Belarus
State Institution NN Alexandrov Republican Scientific and Practical Centre of Oncology And Medical R
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Minsk, Belarus
Clinical Hospital Mostar
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Mostar, Bosnia and Herzegovina
Clinical Center University of Sarajevo
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Sarajevo, Bosnia and Herzegovina
Javna zdravstvena ustanova bolnica Trebinje
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Trebinje, Bosnia and Herzegovina
County Hospital Zenica
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Zenica, Bosnia and Herzegovina
Complex Oncology Center-Veliko Tarnovo
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Veliko Tarnovo, Bulgaria
Complex Oncology Center - Vratsa EOOD
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Vratsa, Bulgaria
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Grodno Clinical Regional Hospital
🇧🇾Mogilev, Belarus