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

NSCLC Stage IV Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04633564
• Other study ID #: MYL-1402O-3001
• Status: Completed
• Phase: Phase 3
• Start date: January 21, 2017
• Est. completion date: November 22, 2019

Study information

• Verified date: March 2022
• Source: Viatris Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 671
• Est. completion date: November 22, 2019
• Est. primary completion date: June 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• NSCLC Stage IV

Intervention

Biological:
• Bevacizumab as MYL-1402O
Bevacizumab as MYL-1402O 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV
• Bevacizumab as Avastin
Bevacizumab as Avastin 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Mylan Pharmaceuticals Inc

Countries where clinical trial is conducted

Belarus,  Bosnia and Herzegovina,  Bulgaria,  Croatia,  Georgia,  Hungary,  India,  Italy,  Philippines,  Poland,  Romania,  Russian Federation,  Spain,  Taiwan,  Turkey,  Ukraine,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Efficacy Analysis of Overall Response Rate ( ORR) of MYL-1402O as Compared to Avastin	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.	18 weeks after first dosing per patient