Clinical trial NCT04633564: MYL-1402O Compared With Avastin®, in Patients With Stage IV nsNSCLC
Official title: Multicenter, Double-Blind, Randomized, Parallel-Group Study to 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: NSCLC Stage IV
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
First posted: 2020-11-18
Enrollment: 671
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, Double-Blind, Randomized, Parallel-Group
Primary purpose: TREATMENT

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).

Eligibility 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.

Primary outcomes:
measure: Primary Efficacy Analysis of Overall Response Rate ( ORR) of MYL-1402O as Compared to Avastin
timeFrame: 18 weeks after first dosing per patient
Secondary outcomes:
Other outcomes:
Locations:
city: Grodno
country: Belarus
facility: Grodno Clinical Regional Hospital
state: Hrodzenskaya Voblasts
city: Minsk
country: Belarus
facility: Mogilev Regional Oncology Dispensary
state: Minskaya Voblasts
city: Babruysk
country: Belarus
facility: Babruysk Interregional Oncological Dispensary
city: Minsk
country: Belarus
facility: State Institution NN Alexandrov Republican Scientific and Practical Centre of Oncology And Medical R
city: Mogilev
country: Belarus
facility: Grodno Clinical Regional Hospital
city: Mostar
country: Bosnia and Herzegovina
facility: Clinical Hospital Mostar
city: Sarajevo
country: Bosnia and Herzegovina
facility: Clinical Center University of Sarajevo
city: Trebinje
country: Bosnia and Herzegovina
facility: Javna zdravstvena ustanova bolnica Trebinje
city: Zenica
country: Bosnia and Herzegovina
facility: County Hospital Zenica
city: Veliko Tarnovo
country: Bulgaria
facility: Complex Oncology Center-Veliko Tarnovo
city: Vratsa
country: Bulgaria
facility: Complex Oncology Center - Vratsa EOOD
city: Osijek
country: Croatia
facility: Clinical Hospital Centre Osijek
city: Sibenik
country: Croatia
facility: General Hospital Sibenik
city: Zagreb
country: Croatia
facility: Clinical Hospital Center Zagreb - PPDS
city: Tbilisi
country: Georgia
facility: Research Institute of Clinical Medicine
city: Tbilisi
country: Georgia
facility: LTD High Technology Medical Center University Clinic
city: Budapest
country: Hungary
facility: Orszagos Koranyi Pulmonologiai Intezet
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Farkasgyepü
country: Hungary
facility: Veszprem Megyei Tudogyogyintezet
city: Miskolc
country: Hungary
facility: Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktató Kórház
city: Vijayawada
country: India
facility: City Cancer Center
state: Andhra Pradesh
city: Visakhapatnam
country: India
facility: Mahatma Gandhi Medical College and Hospital
state: Andhra Pradesh
city: Patna
country: India
facility: Regional Cancer Centre Indira Gandhi Institute of Medical Sciences
state: Bihar
city: Ahmedabad
country: India
facility: HCG Cancer Center
state: Gujarat
city: Rajkot
country: India
facility: Shree Giriraj Multispeciality Hospital
state: Gujarat
city: Surat
country: India
facility: Synexus Affiliate - Apple Hospital
state: Gujarat
city: Surat
country: India
facility: Unique Hospital - Multispeciality & Research Institute
state: Gujarat
city: Hisar
country: India
facility: Aadhar Health Institute
state: Haryana
city: Bangalore
country: India
facility: BGS Global Hospital
state: Karnataka
city: Bangalore
country: India
facility: Sri Venkateshwara Hospital
state: Karnataka
city: Bengaluru
country: India
facility: Shetty's Hospital
state: Karnataka
city: Amravati
country: India
facility: Amravati Cancer Foundation Sujan Surgical and Cancer Hospital
state: Maharashtra
city: Aurangabad
country: India
facility: United CIIGMA Institute of Medical Sciences Pvt.Ltd.
state: Maharashtra
city: Aurangabad
country: India
facility: Seth Nandlal Dhoot Hospital
state: Maharashtra
city: Nagpur
country: India
facility: Government Medical College
state: Maharashtra
city: Nashik
country: India
facility: Curie Manavata Cancer Centre
state: Maharashtra
city: Pune
country: India
facility: Ruby Hall Clinic
state: Maharashtra
city: Bikaner
country: India
facility: Acharya Tulsi Regional Cancer Institute and Research Centre
state: Rajasthan
city: Jaipur
country: India
facility: Malpani Multispecialty Hospital
state: Rajasthan
city: Jaipur
country: India
facility: Institute of Respiratory Diseases (Chest and TB Hospital)
state: Rajasthan
city: Jaipur
country: India
facility: Apex Hospital
state: Rajasthan
city: Jaipur
country: India
facility: Bhagwan Mahaveer Cancer Hospital and Research Centre
state: Rajasthan
city: Chennai
country: India
facility: Rajiv Gandhi Government General Hospital
state: Tamil Nadu
city: Madurai
country: India
facility: Meenakshi Mission Hospital and Research Center
state: Tamil Nadu
city: Lucknow
country: India
facility: Shatabdi Superspeciality Hospital
state: Uttar Pradesh
city: Kolkata
country: India
facility: Chittaranjan National Cancer Institute
state: West Bengal
city: Belagave
country: India
facility: KLES Dr Prabhakar Kore Hospital and Medical Research Centre
city: Mumbai
country: India
facility: Prince Aly Khan Hospital Mumbai
city: Mumbai
country: India
facility: Jaslok Hospital and Research Centre
city: Pune
country: India
facility: Sahyadri Speciality Hospital
city: Vadodara
country: India
facility: Kailash Cancer Hospital and Research Centre
city: Pontedera
country: Italy
facility: Ospedale Felice Lotti De Pontedera
city: Manila
country: Philippines
facility: Philippine General Hospital
state: National Capital Region
city: San Juan City
country: Philippines
facility: Cardinal Santos Medical Center
state: National Capital Region
city: Poznań
country: Poland
facility: Med-Polonia Sp. z o.o.
city: Radom
country: Poland
facility: Radomskie Centrum Onkologii
city: Cluj-Napoca
country: Romania
facility: Medisprof SRL
state: Cluj
city: Ploiesti
country: Romania
facility: Ploiesti Municipal Hospital
state: Prahova
city: Focsani
country: Romania
facility: Spitalul Judetean de Urgenta Sf. Pantelimon Focsani
state: Vrancea
city: Bucharest
country: Romania
facility: Elias Emergency University Hospital
city: Bucharest
country: Romania
facility: Prof. Dr. Alexandru Trestioreanu Oncologic Institute
city: Constanta
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Constanta
city: Craiova
country: Romania
facility: Oncology Center Sfantul Nectarie
city: Arkhangelsk
country: Russian Federation
facility: Arkhangelsk Regional Clinical Oncology Dispensary
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Clinical Oncology Dispensary
city: Kaluga
country: Russian Federation
facility: Kaluga Regional Oncology Dispensary
city: Kazan
country: Russian Federation
facility: Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
city: Kursk
country: Russian Federation
facility: Kursk Regional Oncology Centre
city: Moscow
country: Russian Federation
facility: Vitamed
city: Novosibirsk
country: Russian Federation
facility: City Clinical Hospital #1
city: Omsk
country: Russian Federation
facility: Clinical Oncology Dispensary
city: Pyatigorsk
country: Russian Federation
facility: Stavropol Regional Clinical Oncology Centre Pyatigorsk Affiliate
city: Ryazan
country: Russian Federation
facility: Ryazan State Medical University n.a. I.P. Pavlov
city: Saransk
country: Russian Federation
facility: Mordovia State University
city: St. Petersburg
country: Russian Federation
facility: Research Institute of Phtisio-pneumology
city: St. Petersburg
country: Russian Federation
facility: Leningrad Regional Clinical Hospital
city: St. Petersburg
country: Russian Federation
facility: Railway Clinical Hospital JSC RZhD
city: St. Petersburg
country: Russian Federation
facility: Clinical Theoretical and Practical Center of Specialized Kinds of Medical Care
city: St. Petersburg
country: Russian Federation
facility: Scientific Research Institute of Oncology n.a. N.N. Petrov
city: St. Petersburg
country: Russian Federation
facility: City Clinical Oncology Dispensary
city: Tomsk
country: Russian Federation
facility: Research Oncology Institute of Tomsk Scientific Center
city: Volgograd
country: Russian Federation
facility: Volgograd Regional Clinical Oncology Dispensary
city: Yaroslavl
country: Russian Federation
facility: Regional Clinical Oncology Hospital
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebrón - PPDS
city: Palma de Mallorca
country: Spain
facility: Hospital Son Llatzer
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital
city: Kaohsiung
country: Taiwan
facility: E-DA hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital-Taipei branch
city: Ankara
country: Turkey
facility: Gazi University Medical Faculty Gazi Hospital
city: Izmir
country: Turkey
facility: Ege Universitesi Tip Fakultesi Hastanesi
city: Dnipropetrovsk
country: Ukraine
facility: Municipal Institution City Clinical Hospital #4 of Dnipro City Council - PPDS
city: Ivano-Frankivsk
country: Ukraine
facility: Municipal Institution SubCarpathian ClinicalOncological Centre
city: Kryvyi Rih
country: Ukraine
facility: MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council
city: Sumy
country: Ukraine
facility: Municipal non profit enterprise of Sumy Regional Council Sumy Regional Clinical Oncology Dispensary
city: Uzhgorod
country: Ukraine
facility: MNPE Central City Clinical Hospital of Uzhhorod City Council
city: Zaporizhzhia
country: Ukraine
facility: MI of Zaporizhzhia Regional Council Zaporizhzhia Regional Clinical Oncology Dispensary
city: Hanoi
country: Vietnam
facility: Bach Mai Hospital
city: Hanoi
country: Vietnam
facility: National Cancer Hospital
city: Hanoi
country: Vietnam
facility: National Lung Hospital
city: Ho Chi Minh City
country: Vietnam
facility: Cho Ray Hospital
Study officials:
name: Tazeen A Idris, MD
role: STUDY_DIRECTOR
References: