MYL-1402O Compared With Avastin®, in Patients With Stage IV nsNSCLC
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
1 other identifier
interventional
671
17 countries
102
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2017
Typical duration for phase_3
102 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 5, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 22, 2019
CompletedFirst Submitted
Initial submission to the registry
November 2, 2020
CompletedFirst Posted
Study publicly available on registry
November 18, 2020
CompletedResults Posted
Study results publicly available
February 1, 2021
CompletedMarch 16, 2022
March 1, 2022
2.4 years
November 2, 2020
January 11, 2021
March 15, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
MYL-1402O
EXPERIMENTALPatients 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
ACTIVE COMPARATORPatients 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.
Interventions
Bevacizumab as MYL-1402O 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV
Bevacizumab as Avastin 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (102)
Grodno Clinical Regional Hospital
Grodno, Hrodzenskaya Voblasts, 230017, Belarus
Mogilev Regional Oncology Dispensary
Minsk, Minsk Oblast, 220013, Belarus
Babruysk Interregional Oncological Dispensary
Babruysk, 213825, Belarus
State Institution NN Alexandrov Republican Scientific and Practical Centre of Oncology And Medical R
Minsk, 223040, Belarus
Grodno Clinical Regional Hospital
Mogilev, 212018, Belarus
Clinical Hospital Mostar
Mostar, Bosnia and Herzegovina
Clinical Center University of Sarajevo
Sarajevo, 71000, Bosnia and Herzegovina
Javna zdravstvena ustanova bolnica Trebinje
Trebinje, 89101, Bosnia and Herzegovina
County Hospital Zenica
Zenica, Bosnia and Herzegovina
Complex Oncology Center-Veliko Tarnovo
Veliko Tarnovo, 5000, Bulgaria
Complex Oncology Center - Vratsa EOOD
Vratsa, 30001, Bulgaria
Clinical Hospital Centre Osijek
Osijek, 31000, Croatia
General Hospital Sibenik
Šibenik, 22000, Croatia
Clinical Hospital Center Zagreb - PPDS
Zagreb, 10000, Croatia
Research Institute of Clinical Medicine
Tbilisi, 112, Georgia
LTD High Technology Medical Center University Clinic
Tbilisi, 144, 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, 520002, India
Mahatma Gandhi Medical College and Hospital
Visakhapatnam, Andhra Pradesh, 530017, India
Regional Cancer Centre Indira Gandhi Institute of Medical Sciences
Patna, Bihar, 800014, India
HCG Cancer Center
Ahmedabad, Gujarat, 380060, India
Shree Giriraj Multispeciality Hospital
Rajkot, Gujarat, 360005, India
Synexus Affiliate - Apple Hospital
Surat, Gujarat, 395002, India
Unique Hospital - Multispeciality & Research Institute
Surat, Gujarat, 395002, India
Aadhar Health Institute
Hisar, Haryana, 125001, India
BGS Global Hospital
Bangalore, Karnataka, 560060, India
Sri Venkateshwara Hospital
Bangalore, Karnataka, 560068, India
Shetty's Hospital
Bengaluru, Karnataka, 560068, India
Amravati Cancer Foundation Sujan Surgical and Cancer Hospital
Amravati, Maharashtra, 444606, India
United CIIGMA Institute of Medical Sciences Pvt.Ltd.
Aurangabad, Maharashtra, 431005, India
Seth Nandlal Dhoot Hospital
Aurangabad, Maharashtra, 431210, India
Government Medical College
Nagpur, Maharashtra, 440003, India
Curie Manavata Cancer Centre
Nashik, Maharashtra, 422004, India
Ruby Hall Clinic
Pune, Maharashtra, 411001, India
Acharya Tulsi Regional Cancer Institute and Research Centre
Bikaner, Rajasthan, 334003, India
Malpani Multispecialty Hospital
Jaipur, Rajasthan, 302013, India
Institute of Respiratory Diseases (Chest and TB Hospital)
Jaipur, Rajasthan, 302016, India
Apex Hospital
Jaipur, Rajasthan, 302017, India
Bhagwan Mahaveer Cancer Hospital and Research Centre
Jaipur, Rajasthan, 302017, India
Rajiv Gandhi Government General Hospital
Chennai, Tamil Nadu, 600003, India
Meenakshi Mission Hospital and Research Center
Madurai, Tamil Nadu, 625107, India
Shatabdi Superspeciality Hospital
Lucknow, Uttar Pradesh, 226003, India
Chittaranjan National Cancer Institute
Kolkata, West Bengal, 700026, India
KLES Dr Prabhakar Kore Hospital and Medical Research Centre
Belagāve, 590010, India
Prince Aly Khan Hospital Mumbai
Mumbai, 400010, India
Jaslok Hospital and Research Centre
Mumbai, 400026, India
Sahyadri Speciality Hospital
Pune, 411004, India
Kailash Cancer Hospital and Research Centre
Vadodara, 391760, India
Ospedale Felice Lotti De Pontedera
Pontedera, 56025, Italy
Philippine General Hospital
Manila, National Capital Region, 1000, Philippines
Cardinal Santos Medical Center
San Juan City, National Capital Region, 1502, Philippines
Med-Polonia Sp. z o.o.
Poznan, 60-693, Poland
Radomskie Centrum Onkologii
Radom, 26-600, Poland
Medisprof SRL
Cluj-Napoca, Cluj, 400641, Romania
Ploiesti Municipal Hospital
Ploieşti, Prahova, 100337, Romania
Spitalul Judetean de Urgenta Sf. Pantelimon Focsani
Focşani, Vrancea, 620165, Romania
Elias Emergency University Hospital
Bucharest, 11461, Romania
Prof. Dr. Alexandru Trestioreanu Oncologic Institute
Bucharest, 22328, Romania
Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Constanta
Constanța, 900591, Romania
Oncology Center Sfantul Nectarie
Craiova, Romania
Arkhangelsk Regional Clinical Oncology Dispensary
Arkhangelsk, 163045, Russia
Chelyabinsk Regional Clinical Oncology Dispensary
Chelyabinsk, 454087, Russia
Kaluga Regional Oncology Dispensary
Kaluga, 248007, Russia
Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
Kazan', 420029, Russia
Kursk Regional Oncology Centre
Kursk, 305524, Russia
Vitamed
Moscow, 129515, Russia
City Clinical Hospital #1
Novosibirsk, 630047, Russia
Clinical Oncology Dispensary
Omsk, 644013, Russia
Stavropol Regional Clinical Oncology Centre Pyatigorsk Affiliate
Pyatigorsk, 357502, Russia
Ryazan State Medical University n.a. I.P. Pavlov
Ryazan, 390011, Russia
Research Institute of Phtisio-pneumology
Saint Petersburg, 191036, Russia
Leningrad Regional Clinical Hospital
Saint Petersburg, 194291, Russia
Railway Clinical Hospital JSC RZhD
Saint Petersburg, 195271, Russia
Clinical Theoretical and Practical Center of Specialized Kinds of Medical Care
Saint Petersburg, 197758, Russia
Scientific Research Institute of Oncology n.a. N.N. Petrov
Saint Petersburg, 197758, Russia
City Clinical Oncology Dispensary
Saint Petersburg, 198255, Russia
Mordovia State University
Saransk, 430000, Russia
Research Oncology Institute of Tomsk Scientific Center
Tomsk, 634028, Russia
Volgograd Regional Clinical Oncology Dispensary
Volgograd, 400138, Russia
Regional Clinical Oncology Hospital
Yaroslavl, 150040, Russia
Hospital Universitario Vall d'Hebrón - PPDS
Barcelona, 8035, Spain
Hospital Son Llatzer
Palma de Mallorca, 7198, Spain
Kaohsiung Medical University Hospital
Kaohsiung City, 807, Taiwan
E-DA hospital
Kaohsiung City, 82544, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
Mackay Memorial Hospital-Taipei branch
Taipei, 10449, Taiwan
Gazi University Medical Faculty Gazi Hospital
Ankara, 6500, Turkey (Türkiye)
Ege Universitesi Tip Fakultesi Hastanesi
Izmir, 35100, Turkey (Türkiye)
Municipal Institution City Clinical Hospital #4 of Dnipro City Council - PPDS
Dnipropetrovsk, 49102, Ukraine
Municipal Institution SubCarpathian ClinicalOncological Centre
Ivano-Frankivsk, 76018, Ukraine
MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council
Kryvyi Rih, 50048, Ukraine
Municipal non profit enterprise of Sumy Regional Council Sumy Regional Clinical Oncology Dispensary
Sumy, 40022, Ukraine
MNPE Central City Clinical Hospital of Uzhhorod City Council
Uzhhorod, 88000, Ukraine
MI of Zaporizhzhia Regional Council Zaporizhzhia Regional Clinical Oncology Dispensary
Zaporizhzhia, 69040, Ukraine
Bach Mai Hospital
Hanoi, 100000, Vietnam
National Cancer Hospital
Hanoi, 100000, Vietnam
National Lung Hospital
Hanoi, 100000, Vietnam
Cho Ray Hospital
Ho Chi Minh City, 700000, Vietnam
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Keri Vaughan, Senior Director
- Organization
- Mylan GmbH
Study Officials
- STUDY DIRECTOR
Tazeen A Idris, MD
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 2020
First Posted
November 18, 2020
Study Start
January 21, 2017
Primary Completion
June 5, 2019
Study Completion
November 22, 2019
Last Updated
March 16, 2022
Results First Posted
February 1, 2021
Record last verified: 2022-03