MYL-1402O Compared With Avastin®, in Patients With Stage IV nsNSCLC
- Conditions
- NSCLC Stage IV
- Interventions
- Biological: Bevacizumab as MYL-1402OBiological: Bevacizumab as Avastin
- Registration Number
- NCT04633564
- Lead Sponsor
- Mylan Pharmaceuticals Inc
- 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
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 671
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MYL-1402O Bevacizumab as MYL-1402O 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. Avastin Bevacizumab as Avastin 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.
- 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
Trial Locations
- Locations (101)
LTD High Technology Medical Center University Clinic
🇬🇪Tbilisi, Georgia
Radomskie Centrum Onkologii
🇵🇱Radom, Poland
Arkhangelsk Regional Clinical Oncology Dispensary
🇷🇺Arkhangelsk, Russian Federation
Veszprem Megyei Tudogyogyintezet
🇭🇺Farkasgyepü, Hungary
Research Institute of Clinical Medicine
🇬🇪Tbilisi, Georgia
Synexus Affiliate - Apple Hospital
🇮🇳Surat, Gujarat, India
Clinical Hospital Centre Osijek
🇭🇷Osijek, Croatia
General Hospital Sibenik
🇭🇷Sibenik, Croatia
Malpani Multispecialty Hospital
🇮🇳Jaipur, Rajasthan, India
Semmelweis Egyetem
🇭🇺Budapest, Hungary
Regional Cancer Centre Indira Gandhi Institute of Medical Sciences
🇮🇳Patna, Bihar, India
Ospedale Felice Lotti De Pontedera
🇮🇹Pontedera, Italy
City Cancer Center
🇮🇳Vijayawada, Andhra Pradesh, India
Shree Giriraj Multispeciality Hospital
🇮🇳Rajkot, Gujarat, India
Acharya Tulsi Regional Cancer Institute and Research Centre
🇮🇳Bikaner, Rajasthan, India
Prince Aly Khan Hospital Mumbai
🇮🇳Mumbai, India
Clinical Hospital Center Zagreb - PPDS
🇭🇷Zagreb, Croatia
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktató Kórház
🇭🇺Miskolc, Hungary
Shatabdi Superspeciality Hospital
🇮🇳Lucknow, Uttar Pradesh, India
BGS Global Hospital
🇮🇳Bangalore, Karnataka, India
Orszagos Koranyi Pulmonologiai Intezet
🇭🇺Budapest, Hungary
Mackay Memorial Hospital-Taipei branch
🇨🇳Taipei, Taiwan
Med-Polonia Sp. z o.o.
🇵🇱Poznań, Poland
Municipal Institution City Clinical Hospital #4 of Dnipro City Council - PPDS
🇺🇦Dnipropetrovsk, Ukraine
Mahatma Gandhi Medical College and Hospital
🇮🇳Visakhapatnam, Andhra Pradesh, India
Hospital Son Llatzer
🇪🇸Palma de Mallorca, Spain
Municipal non profit enterprise of Sumy Regional Council Sumy Regional Clinical Oncology Dispensary
🇺🇦Sumy, Ukraine
Complex Oncology Center - Vratsa EOOD
🇧🇬Vratsa, Bulgaria
Kaluga Regional Oncology Dispensary
🇷🇺Kaluga, Russian Federation
Spitalul Judetean de Urgenta Sf. Pantelimon Focsani
🇷🇴Focsani, Vrancea, Romania
Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
🇷🇺Kazan, Russian Federation
City Clinical Hospital #1
🇷🇺Novosibirsk, Russian Federation
MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council
🇺🇦Kryvyi Rih, Ukraine
Kursk Regional Oncology Centre
🇷🇺Kursk, Russian Federation
Clinical Oncology Dispensary
🇷🇺Omsk, Russian Federation
Ryazan State Medical University n.a. I.P. Pavlov
🇷🇺Ryazan, Russian Federation
Kaohsiung Medical University Hospital
🇨🇳Kaohsiung, Taiwan
Regional Clinical Oncology Hospital
🇷🇺Yaroslavl, Russian Federation
Ege Universitesi Tip Fakultesi Hastanesi
🇹🇷Izmir, Turkey
Municipal Institution SubCarpathian ClinicalOncological Centre
🇺🇦Ivano-Frankivsk, Ukraine
MNPE Central City Clinical Hospital of Uzhhorod City Council
🇺🇦Uzhgorod, Ukraine
Gazi University Medical Faculty Gazi Hospital
🇹🇷Ankara, Turkey
Bach Mai Hospital
🇻🇳Hanoi, Vietnam
MI of Zaporizhzhia Regional Council Zaporizhzhia Regional Clinical Oncology Dispensary
🇺🇦Zaporizhzhia, Ukraine
Grodno Clinical Regional Hospital
🇧🇾Mogilev, Belarus
Mogilev Regional Oncology Dispensary
🇧🇾Minsk, Minskaya Voblasts, Belarus
Clinical Hospital Mostar
🇧🇦Mostar, Bosnia and Herzegovina
Complex Oncology Center-Veliko Tarnovo
🇧🇬Veliko Tarnovo, Bulgaria
Institute of Respiratory Diseases (Chest and TB Hospital)
🇮🇳Jaipur, Rajasthan, India
Apex Hospital
🇮🇳Jaipur, Rajasthan, India
Bhagwan Mahaveer Cancer Hospital and Research Centre
🇮🇳Jaipur, Rajasthan, India
Meenakshi Mission Hospital and Research Center
🇮🇳Madurai, Tamil Nadu, India
Rajiv Gandhi Government General Hospital
🇮🇳Chennai, Tamil Nadu, India
Babruysk Interregional Oncological Dispensary
🇧🇾Babruysk, Belarus
Clinical Center University of Sarajevo
🇧🇦Sarajevo, Bosnia and Herzegovina
State Institution NN Alexandrov Republican Scientific and Practical Centre of Oncology And Medical R
🇧🇾Minsk, Belarus
County Hospital Zenica
🇧🇦Zenica, Bosnia and Herzegovina
United CIIGMA Institute of Medical Sciences Pvt.Ltd.
🇮🇳Aurangabad, Maharashtra, India
Seth Nandlal Dhoot Hospital
🇮🇳Aurangabad, Maharashtra, India
Javna zdravstvena ustanova bolnica Trebinje
🇧🇦Trebinje, Bosnia and Herzegovina
HCG Cancer Center
🇮🇳Ahmedabad, Gujarat, India
Aadhar Health Institute
🇮🇳Hisar, Haryana, India
Ploiesti Municipal Hospital
🇷🇴Ploiesti, Prahova, Romania
Shetty's Hospital
🇮🇳Bengaluru, Karnataka, India
Prof. Dr. Alexandru Trestioreanu Oncologic Institute
🇷🇴Bucharest, Romania
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
Unique Hospital - Multispeciality & Research Institute
🇮🇳Surat, Gujarat, India
Sri Venkateshwara Hospital
🇮🇳Bangalore, Karnataka, India
Philippine General Hospital
🇵🇭Manila, National Capital Region, Philippines
Cardinal Santos Medical Center
🇵🇭San Juan City, National Capital Region, Philippines
Amravati Cancer Foundation Sujan Surgical and Cancer Hospital
🇮🇳Amravati, Maharashtra, India
Government Medical College
🇮🇳Nagpur, Maharashtra, India
Curie Manavata Cancer Centre
🇮🇳Nashik, Maharashtra, India
Kailash Cancer Hospital and Research Centre
🇮🇳Vadodara, India
Medisprof SRL
🇷🇴Cluj-Napoca, Cluj, Romania
Sahyadri Speciality Hospital
🇮🇳Pune, India
Elias Emergency University Hospital
🇷🇴Bucharest, Romania
E-DA hospital
🇨🇳Kaohsiung, Taiwan
National Cancer Hospital
🇻🇳Hanoi, Vietnam
National Lung Hospital
🇻🇳Hanoi, Vietnam
KLES Dr Prabhakar Kore Hospital and Medical Research Centre
🇮🇳Belagave, India
Jaslok Hospital and Research Centre
🇮🇳Mumbai, India
Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Constanta
🇷🇴Constanta, Romania
Oncology Center Sfantul Nectarie
🇷🇴Craiova, Romania
Cho Ray Hospital
🇻🇳Ho Chi Minh City, Vietnam
Stavropol Regional Clinical Oncology Centre Pyatigorsk Affiliate
🇷🇺Pyatigorsk, Russian Federation
Vitamed
🇷🇺Moscow, Russian Federation
Research Institute of Phtisio-pneumology
🇷🇺St. Petersburg, Russian Federation
Leningrad Regional Clinical Hospital
🇷🇺St. Petersburg, Russian Federation
Railway Clinical Hospital JSC RZhD
🇷🇺St. Petersburg, Russian Federation
Clinical Theoretical and Practical Center of Specialized Kinds of Medical Care
🇷🇺St. Petersburg, Russian Federation
Scientific Research Institute of Oncology n.a. N.N. Petrov
🇷🇺St. Petersburg, Russian Federation
City Clinical Oncology Dispensary
🇷🇺St. Petersburg, Russian Federation
Research Oncology Institute of Tomsk Scientific Center
🇷🇺Tomsk, Russian Federation
Volgograd Regional Clinical Oncology Dispensary
🇷🇺Volgograd, Russian Federation
Hospital Universitario Vall d'Hebrón - PPDS
🇪🇸Barcelona, Spain
Debreceni Egyetem Klinikai Kozpont
🇭🇺Debrecen, Hungary
Chelyabinsk Regional Clinical Oncology Dispensary
🇷🇺Chelyabinsk, Russian Federation
Mordovia State University
🇷🇺Saransk, Russian Federation
Chittaranjan National Cancer Institute
🇮🇳Kolkata, West Bengal, India
Ruby Hall Clinic
🇮🇳Pune, Maharashtra, India