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

NCT ID: NCT04633564

Last Updated: 2022-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 671 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-21
• Study Completion Date: 2019-11-22

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).

Conditions

NSCLC Stage IV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Bevacizumab as MYL-1402O

Intervention Type: BIOLOGICAL

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

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.

Group Type: ACTIVE_COMPARATOR

Bevacizumab as Avastin

Intervention Type: BIOLOGICAL

Bevacizumab as Avastin 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV

Interventions

Bevacizumab as MYL-1402O

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

Intervention Type: BIOLOGICAL

Bevacizumab as Avastin

Bevacizumab as Avastin 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mylan Pharmaceuticals Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tazeen A Idris, MD

Role: STUDY_DIRECTOR

Locations

Grodno Clinical Regional Hospital

Grodno, Hrodzenskaya Voblasts, Belarus

Mogilev Regional Oncology Dispensary

Minsk, Minsk Oblast, Belarus

Babruysk Interregional Oncological Dispensary

Babruysk, , Belarus

State Institution NN Alexandrov Republican Scientific and Practical Centre of Oncology And Medical R

Minsk, , Belarus

Grodno Clinical Regional Hospital

Mogilev, , Belarus

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, , Bosnia and Herzegovina

Complex Oncology Center-Veliko Tarnovo

Veliko Tarnovo, , Bulgaria

Complex Oncology Center - Vratsa EOOD

Vratsa, , Bulgaria

Clinical Hospital Centre Osijek

Osijek, , Croatia

General Hospital Sibenik

Šibenik, , Croatia

Clinical Hospital Center Zagreb - PPDS

Zagreb, , Croatia

Research Institute of Clinical Medicine

Tbilisi, , Georgia

LTD High Technology Medical Center University Clinic

Tbilisi, , Georgia

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, , Hungary

City Cancer Center

Vijayawada, Andhra Pradesh, India

Mahatma Gandhi Medical College and Hospital

Visakhapatnam, Andhra Pradesh, India

Regional Cancer Centre Indira Gandhi Institute of Medical Sciences

Patna, Bihar, India

HCG Cancer Center

Ahmedabad, Gujarat, India

Shree Giriraj Multispeciality Hospital

Rajkot, Gujarat, India

Synexus Affiliate - Apple Hospital

Surat, Gujarat, India

Unique Hospital - Multispeciality & Research Institute

Surat, Gujarat, India

Aadhar Health Institute

Hisar, Haryana, India

BGS Global Hospital

Bangalore, Karnataka, India

Sri Venkateshwara Hospital

Bangalore, Karnataka, India

Shetty's Hospital

Bengaluru, Karnataka, India

Amravati Cancer Foundation Sujan Surgical and Cancer Hospital

Amravati, Maharashtra, India

United CIIGMA Institute of Medical Sciences Pvt.Ltd.

Aurangabad, Maharashtra, India

Seth Nandlal Dhoot Hospital

Aurangabad, Maharashtra, India

Government Medical College

Nagpur, Maharashtra, India

Curie Manavata Cancer Centre

Nashik, Maharashtra, India

Ruby Hall Clinic

Pune, Maharashtra, India

Acharya Tulsi Regional Cancer Institute and Research Centre

Bikaner, Rajasthan, India

Malpani Multispecialty Hospital

Jaipur, Rajasthan, India

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

Rajiv Gandhi Government General Hospital

Chennai, Tamil Nadu, India

Meenakshi Mission Hospital and Research Center

Madurai, Tamil Nadu, India

Shatabdi Superspeciality Hospital

Lucknow, Uttar Pradesh, India

Chittaranjan National Cancer Institute

Kolkata, West Bengal, India

KLES Dr Prabhakar Kore Hospital and Medical Research Centre

Belagāve, , India

Prince Aly Khan Hospital Mumbai

Mumbai, , India

Jaslok Hospital and Research Centre

Mumbai, , India

Sahyadri Speciality Hospital

Pune, , India

Kailash Cancer Hospital and Research Centre

Vadodara, , India

Ospedale Felice Lotti De Pontedera

Pontedera, , Italy

Philippine General Hospital

Manila, National Capital Region, Philippines

Cardinal Santos Medical Center

San Juan City, National Capital Region, Philippines

Med-Polonia Sp. z o.o.

Poznan, , Poland

Radomskie Centrum Onkologii

Radom, , Poland

Medisprof SRL

Cluj-Napoca, Cluj, Romania

Ploiesti Municipal Hospital

Ploieşti, Prahova, Romania

Spitalul Judetean de Urgenta Sf. Pantelimon Focsani

Focşani, Vrancea, Romania

Elias Emergency University Hospital

Bucharest, , Romania

Prof. Dr. Alexandru Trestioreanu Oncologic Institute

Bucharest, , Romania

Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Constanta

Constanța, , Romania

Oncology Center Sfantul Nectarie

Craiova, , Romania

Arkhangelsk Regional Clinical Oncology Dispensary

Arkhangelsk, , Russia

Chelyabinsk Regional Clinical Oncology Dispensary

Chelyabinsk, , Russia

Kaluga Regional Oncology Dispensary

Kaluga, , Russia

Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic

Kazan', , Russia

Kursk Regional Oncology Centre

Kursk, , Russia

Vitamed

Moscow, , Russia

City Clinical Hospital #1

Novosibirsk, , Russia

Clinical Oncology Dispensary

Omsk, , Russia

Stavropol Regional Clinical Oncology Centre Pyatigorsk Affiliate

Pyatigorsk, , Russia

Ryazan State Medical University n.a. I.P. Pavlov

Ryazan, , Russia

Research Institute of Phtisio-pneumology

Saint Petersburg, , Russia

Leningrad Regional Clinical Hospital

Saint Petersburg, , Russia

Railway Clinical Hospital JSC RZhD

Saint Petersburg, , Russia

Clinical Theoretical and Practical Center of Specialized Kinds of Medical Care

Saint Petersburg, , Russia

Scientific Research Institute of Oncology n.a. N.N. Petrov

Saint Petersburg, , Russia

City Clinical Oncology Dispensary

Saint Petersburg, , Russia

Mordovia State University

Saransk, , Russia

Research Oncology Institute of Tomsk Scientific Center

Tomsk, , Russia

Volgograd Regional Clinical Oncology Dispensary

Volgograd, , Russia

Regional Clinical Oncology Hospital

Yaroslavl, , Russia

Hospital Universitario Vall d'Hebrón - PPDS

Barcelona, , Spain

Hospital Son Llatzer

Palma de Mallorca, , Spain

Kaohsiung Medical University Hospital

Kaohsiung City, , Taiwan

E-DA hospital

Kaohsiung City, , Taiwan

Taichung Veterans General Hospital

Taichung, , Taiwan

Mackay Memorial Hospital-Taipei branch

Taipei, , Taiwan

Gazi University Medical Faculty Gazi Hospital

Ankara, , Turkey (Türkiye)

Ege Universitesi Tip Fakultesi Hastanesi

Izmir, , Turkey (Türkiye)

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

Uzhhorod, , Ukraine

MI of Zaporizhzhia Regional Council Zaporizhzhia Regional Clinical Oncology Dispensary

Zaporizhzhia, , Ukraine

Bach Mai Hospital

Hanoi, , Vietnam

National Cancer Hospital

Hanoi, , Vietnam

National Lung Hospital

Hanoi, , Vietnam

Cho Ray Hospital

Ho Chi Minh City, , Vietnam

Countries

Belarus; Bosnia and Herzegovina; Bulgaria; Croatia; Georgia; Hungary; India; Italy; Philippines; Poland; Romania; Russia; Spain; Taiwan; Turkey (Türkiye); Ukraine; Vietnam

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

MYL-1402O-3001

Identifier Type: -

Identifier Source: org_study_id