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

Mylan

Status and phase: Completed; Phase 3

Conditions: NSCLC Stage IV

Treatments: Biological: Bevacizumab as Avastin; Biological: Bevacizumab as MYL-1402O

Study type: Interventional

Funder types: Industry

Identifiers

NCT04633564

MYL-1402O-3001

Details and patient eligibility

About

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

Full 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).

Enrollment: 671 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Written and signed informed consent
2. 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
3. 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.
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
5. 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.
6. Treated and stable brain metastasis.

Key Exclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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671 participants in 2 patient groups

MYL-1402O

Experimental group

Description:

Patients will begin Period 1 receiving bevacizumab combination therapy (MYL-1402O15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV) on Day 0 of Cycle 1 for up to 6 cycles of therapy. Each cycle will consist of 3 weeks (21 days ± 3 days) and a cycle will start with the administration of bevacizumab (as MYL-1402O ). In Period 2, eligible patients will continue to receive bevacizumab ( MYL- 1402O) every 3 weeks as monotherapy.

Treatment:

Biological: Bevacizumab as MYL-1402O

Avastin

Active Comparator group

Description:

Patients will begin Period 1 receiving bevacizumab combination therapy ( Avastin15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV) on Day 0 of Cycle 1 for up to 6 cycles of therapy. Each cycle will consist of 3 weeks (21 days ± 3 days) and a cycle will start with the administration of bevacizumab (as Avastin). In Period 2, eligible patients will continue to receive bevacizumab (Avastin) every 3 weeks as monotherapy.

Treatment:

Biological: Bevacizumab as Avastin