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

March 15, 2022 updated by: Mylan Pharmaceuticals Inc

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

671

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belarus
      • Babruysk, Belarus, 213825
        • Babruysk Interregional Oncological Dispensary
      • Minsk, Belarus, 223040
        • State Institution NN Alexandrov Republican Scientific and Practical Centre of Oncology And Medical R
      • Mogilev, Belarus, 212018
        • Grodno Clinical Regional Hospital
    • Hrodzenskaya Voblasts
      • Grodno, Hrodzenskaya Voblasts, Belarus, 230017
        • Grodno Clinical Regional Hospital
    • Minskaya Voblasts
      • Minsk, Minskaya Voblasts, Belarus, 220013
        • Mogilev Regional Oncology Dispensary
  • Bosnia and Herzegovina
      • Mostar, Bosnia and Herzegovina
        • Clinical hospital Mostar
      • Sarajevo, Bosnia and Herzegovina, 71000
        • Clinical Center University of Sarajevo
      • Trebinje, Bosnia and Herzegovina, 89101
        • Javna zdravstvena ustanova bolnica Trebinje
      • Zenica, Bosnia and Herzegovina
        • County Hospital Zenica
  • Bulgaria
      • Veliko Tarnovo, Bulgaria, 5000
        • Complex Oncology Center-Veliko Tarnovo
      • Vratsa, Bulgaria, 30001
        • Complex Oncology Center - Vratsa EOOD
  • Croatia
      • Osijek, Croatia, 31000
        • Clinical Hospital Centre Osijek
      • Sibenik, Croatia, 22000
        • General Hospital Sibenik
      • Zagreb, Croatia, 10000
        • Clinical Hospital Center Zagreb - PPDS
  • Georgia
      • Tbilisi, Georgia, 112
        • Research Institute of Clinical Medicine
      • Tbilisi, Georgia, 144
        • LTD High Technology Medical Center University Clinic
  • Hungary
      • Budapest, Hungary
        • Semmelweis Egyetem
      • Budapest, Hungary
        • Országos Korányi Pulmonológiai Intézet
      • Debrecen, Hungary
        • Debreceni Egyetem Klinikai Kozpont
      • Farkasgyepü, Hungary
        • Veszprém Megyei Tudőgyógyintézet
      • Miskolc, Hungary
        • Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktato Korhaz
  • India
      • Belagave, India, 590010
        • KLES Dr Prabhakar Kore Hospital and Medical Research Centre
      • Mumbai, India, 400026
        • Jaslok Hospital and Research Centre
      • Mumbai, India, 400010
        • Prince Aly Khan Hospital Mumbai
      • Pune, India, 411004
        • Sahyadri Speciality Hospital
      • Vadodara, India, 391760
        • Kailash Cancer Hospital and Research Centre
    • Andhra Pradesh
      • Vijayawada, Andhra Pradesh, India, 520002
        • City Cancer Center
      • Visakhapatnam, Andhra Pradesh, India, 530017
        • Mahatma Gandhi Medical College and Hospital
    • Bihar
      • Patna, Bihar, India, 800014
        • Regional Cancer Centre Indira Gandhi Institute of Medical Sciences
    • Gujarat
      • Ahmedabad, Gujarat, India, 380060
        • HCG cancer center
      • Rajkot, Gujarat, India, 360005
        • Shree Giriraj Multispeciality Hospital
      • Surat, Gujarat, India, 395002
        • Synexus Affiliate - Apple Hospital
      • Surat, Gujarat, India, 395002
        • Unique Hospital - Multispeciality & Research Institute
    • Haryana
      • Hisar, Haryana, India, 125001
        • Aadhar Health Institute
    • Karnataka
      • Bangalore, Karnataka, India, 560060
        • BGS Global Hospital
      • Bangalore, Karnataka, India, 560068
        • Sri Venkateshwara Hospital
      • Bengaluru, Karnataka, India, 560068
        • Shetty's Hospital
    • Maharashtra
      • Amravati, Maharashtra, India, 444606
        • Amravati Cancer Foundation Sujan Surgical and Cancer Hospital
      • Aurangabad, Maharashtra, India, 431005
        • United CIIGMA Institute of Medical Sciences Pvt.Ltd.
      • Aurangabad, Maharashtra, India, 431210
        • Seth Nandlal Dhoot Hospital
      • Nagpur, Maharashtra, India, 440003
        • Government Medical College
      • Nashik, Maharashtra, India, 422004
        • Curie Manavata Cancer Centre
      • Pune, Maharashtra, India, 411001
        • Ruby Hall Clinic
    • Rajasthan
      • Bikaner, Rajasthan, India, 334003
        • Acharya Tulsi Regional Cancer Institute and Research Centre
      • Jaipur, Rajasthan, India, 302013
        • Malpani Multispecialty Hospital
      • Jaipur, Rajasthan, India, 302016
        • Institute of Respiratory Diseases (Chest and TB Hospital)
      • Jaipur, Rajasthan, India, 302017
        • Apex Hospital
      • Jaipur, Rajasthan, India, 302017
        • Bhagwan Mahaveer Cancer Hospital and Research Centre
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600003
        • Rajiv Gandhi Government General Hospital
      • Madurai, Tamil Nadu, India, 625107
        • Meenakshi Mission Hospital and Research Center
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226003
        • Shatabdi Superspeciality Hospital
    • West Bengal
      • Kolkata, West Bengal, India, 700026
        • Chittaranjan National Cancer Institute
  • Italy
      • Pontedera, Italy, 56025
        • Ospedale Felice Lotti De Pontedera
  • Philippines
    • National Capital Region
      • Manila, National Capital Region, Philippines, 1000
        • Philippine General Hospital
      • San Juan City, National Capital Region, Philippines, 1502
        • Cardinal Santos Medical Center
  • Poland
      • Poznań, Poland, 60-693
        • Med-Polonia Sp. z o.o.
      • Radom, Poland, 26-600
        • Radomskie Centrum Onkologii
  • Romania
      • Bucharest, Romania, 11461
        • Elias Emergency University Hospital
      • Bucharest, Romania, 22328
        • Prof. Dr. Alexandru Trestioreanu Oncologic Institute
      • Constanta, Romania, 900591
        • Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Constanta
      • Craiova, Romania
        • Oncology Center Sfantul Nectarie
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400641
        • Medisprof srl
    • Prahova
      • Ploiesti, Prahova, Romania, 100337
        • Ploiesti Municipal Hospital
    • Vrancea
      • Focsani, Vrancea, Romania, 620165
        • Spitalul Judetean de Urgenta Sf. Pantelimon Focsani
  • Russian Federation
      • Arkhangelsk, Russian Federation, 163045
        • Arkhangelsk Regional Clinical Oncology Dispensary
      • Chelyabinsk, Russian Federation, 454087
        • Chelyabinsk Regional Clinical Oncology Dispensary
      • Kaluga, Russian Federation, 248007
        • Kaluga Regional Oncology Dispensary
      • Kazan, Russian Federation, 420029
        • Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
      • Kursk, Russian Federation, 305524
        • Kursk Regional Oncology Centre
      • Moscow, Russian Federation, 129515
        • Vitamed
      • Novosibirsk, Russian Federation, 630047
        • City Clinical Hospital #1
      • Omsk, Russian Federation, 644013
        • Clinical Oncology Dispensary
      • Pyatigorsk, Russian Federation, 357502
        • Stavropol Regional Clinical Oncology Centre Pyatigorsk Affiliate
      • Ryazan, Russian Federation, 390011
        • Ryazan State Medical University n.a. I.P. Pavlov
      • Saransk, Russian Federation, 430000
        • Mordovia State University
      • St. Petersburg, Russian Federation, 197758
        • Scientific Research Institute of Oncology n.a. N.N. Petrov
      • St. Petersburg, Russian Federation, 198255
        • City Clinical Oncology Dispensary
      • St. Petersburg, Russian Federation, 191036
        • Research Institute of Phtisio-pneumology
      • St. Petersburg, Russian Federation, 194291
        • Leningrad Regional Clinical Hospital
      • St. Petersburg, Russian Federation, 195271
        • Railway Clinical Hospital JSC RZhD
      • St. Petersburg, Russian Federation, 197758
        • Clinical Theoretical and Practical Center of Specialized Kinds of Medical Care
      • Tomsk, Russian Federation, 634028
        • Research Oncology Institute of Tomsk Scientific Center
      • Volgograd, Russian Federation, 400138
        • Volgograd Regional Clinical Oncology Dispensary
      • Yaroslavl, Russian Federation, 150040
        • Regional Clinical Oncology Hospital
  • Spain
      • Barcelona, Spain, 8035
        • Hospital Universitario Vall d'Hebron - PPDS
      • Palma de Mallorca, Spain, 7198
        • Hospital Son Llatzer
  • Taiwan
      • Kaohsiung, Taiwan, 807
        • Kaohsiung Medical University Hospital
      • Kaohsiung, Taiwan, 82544
        • E-Da Hospital
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital
      • Taipei, Taiwan, 10449
        • Mackay Memorial Hospital-Taipei branch
  • Turkey
      • Ankara, Turkey, 6500
        • Gazi University Medical Faculty Gazi Hospital
      • Izmir, Turkey, 35100
        • Ege Universitesi Tip Fakultesi Hastanesi
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49102
        • Municipal Institution City Clinical Hospital #4 of Dnipro City Council - PPDS
      • Ivano-Frankivsk, Ukraine, 76018
        • Municipal Institution SubCarpathian ClinicalOncological Centre
      • Kryvyi Rih, Ukraine, 50048
        • MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council
      • Sumy, Ukraine, 40022
        • Municipal non profit enterprise of Sumy Regional Council Sumy Regional Clinical Oncology Dispensary
      • Uzhgorod, Ukraine, 88000
        • MNPE Central City Clinical Hospital of Uzhhorod City Council
      • Zaporizhzhia, Ukraine, 69040
        • MI of Zaporizhzhia Regional Council Zaporizhzhia Regional Clinical Oncology Dispensary
  • Vietnam
      • Hanoi, Vietnam, 100000
        • Bach Mai hospital
      • Hanoi, Vietnam, 100000
        • National Cancer Hospital
      • Hanoi, Vietnam, 100000
        • National Lung Hospital
      • Ho Chi Minh City, Vietnam, 700000
        • Cho Ray Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Biological: Bevacizumab as MYL-1402O
Bevacizumab as MYL-1402O 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV
Active Comparator: 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.
Biological: Bevacizumab as Avastin
Bevacizumab as Avastin 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mylan Pharmaceuticals Inc

Investigators

  • Study Director: Tazeen A Idris, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2017

Primary Completion (Actual)

June 5, 2019

Study Completion (Actual)

November 22, 2019

Study Registration Dates

First Submitted

November 2, 2020

First Submitted That Met QC Criteria

November 11, 2020

First Posted (Actual)

November 18, 2020

Study Record Updates

Last Update Posted (Actual)

March 16, 2022

Last Update Submitted That Met QC Criteria

March 15, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MYL-1402O-3001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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