NSCLC Stage IVPhase 3NCT04633564
MYL-1402O Compared With Avastin®, in Patients With Stage IV nsNSCLC
A Phase 3 study testing Bevacizumab as MYL-1402O and Bevacizumab as Avastin in people with NSCLC Stage IV, run by Mylan Pharmaceuticals Inc at 102 sites in 17 countries.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC Stage IV
- What is being tested?
- Bevacizumab as MYL-1402O and Bevacizumab as Avastin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 671 participants
- Where
- 102 sitesin 17 countries
- Study dates
- 21 Jan 2017to 22 Nov 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
102 sites in 17 countries.
102 sites in 17 countries
India31 sites
HCG Cancer Center
Ahmedabad, Gujarat, 380060
Amravati Cancer Foundation Sujan Surgical and Cancer Hospital
Amravati, Maharashtra, 444606
BGS Global Hospital
Bangalore, Karnataka, 560060
Sri Venkateshwara Hospital
Bangalore, Karnataka, 560068
KLES Dr Prabhakar Kore Hospital and Medical Research Centre
Belagāve, 590010
Shetty's Hospital
Bengaluru, Karnataka, 560068
Acharya Tulsi Regional Cancer Institute and Research Centre
Bikaner, Rajasthan, 334003
Rajiv Gandhi Government General Hospital
Chennai, Tamil Nadu, 600003
United CIIGMA Institute of Medical Sciences Pvt.Ltd.
Chhatrapati Sambhajinagar, Maharashtra, 431005
Seth Nandlal Dhoot Hospital
Chhatrapati Sambhajinagar, Maharashtra, 431210
Aadhar Health Institute
Hisar, Haryana, 125001
Malpani Multispecialty Hospital
Jaipur, Rajasthan, 302013
Institute of Respiratory Diseases (Chest and TB Hospital)
Jaipur, Rajasthan, 302016
Apex Hospital
Jaipur, Rajasthan, 302017
Bhagwan Mahaveer Cancer Hospital and Research Centre
Jaipur, Rajasthan, 302017
Chittaranjan National Cancer Institute
Kolkata, West Bengal, 700026
Shatabdi Superspeciality Hospital
Lucknow, Uttar Pradesh, 226003
Meenakshi Mission Hospital and Research Center
Madurai, Tamil Nadu, 625107
Prince Aly Khan Hospital Mumbai
Mumbai, 400010
Jaslok Hospital and Research Centre
Mumbai, 400026
Government Medical College
Nagpur, Maharashtra, 440003
Curie Manavata Cancer Centre
Nashik, Maharashtra, 422004
Regional Cancer Centre Indira Gandhi Institute of Medical Sciences
Patna, Bihar, 800014
Ruby Hall Clinic
Pune, Maharashtra, 411001
Sahyadri Speciality Hospital
Pune, 411004
Shree Giriraj Multispeciality Hospital
Rajkot, Gujarat, 360005
Synexus Affiliate - Apple Hospital
Surat, Gujarat, 395002
Unique Hospital - Multispeciality & Research Institute
Surat, Gujarat, 395002
Kailash Cancer Hospital and Research Centre
Vadodara, 391760
City Cancer Center
Vijayawada, Andhra Pradesh, 520002
Mahatma Gandhi Medical College and Hospital
Visakhapatnam, Andhra Pradesh, 530017
Russia20 sites
Arkhangelsk Regional Clinical Oncology Dispensary
Arkhangelsk, 163045
Chelyabinsk Regional Clinical Oncology Dispensary
Chelyabinsk, 454087
Kaluga Regional Oncology Dispensary
Kaluga, 248007
Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
Kazan', 420029
Kursk Regional Oncology Centre
Kursk, 305524
Vitamed
Moscow, 129515
City Clinical Hospital #1
Novosibirsk, 630047
Clinical Oncology Dispensary
Omsk, 644013
Stavropol Regional Clinical Oncology Centre Pyatigorsk Affiliate
Pyatigorsk, 357502
Ryazan State Medical University n.a. I.P. Pavlov
Ryazan, 390011
Research Institute of Phtisio-pneumology
Saint Petersburg, 191036
Leningrad Regional Clinical Hospital
Saint Petersburg, 194291
Railway Clinical Hospital JSC RZhD
Saint Petersburg, 195271
Clinical Theoretical and Practical Center of Specialized Kinds of Medical Care
Saint Petersburg, 197758
Scientific Research Institute of Oncology n.a. N.N. Petrov
Saint Petersburg, 197758
City Clinical Oncology Dispensary
Saint Petersburg, 198255
Mordovia State University
Saransk, 430000
Research Oncology Institute of Tomsk Scientific Center
Tomsk, 634028
Volgograd Regional Clinical Oncology Dispensary
Volgograd, 400138
Regional Clinical Oncology Hospital
Yaroslavl, 150040
Romania7 sites
Elias Emergency University Hospital
Bucharest, 11461
Prof. Dr. Alexandru Trestioreanu Oncologic Institute
Bucharest, 22328
Medisprof SRL
Cluj-Napoca, Cluj, 400641
Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Constanta
Constanța, 900591
Oncology Center Sfantul Nectarie
Craiova
Spitalul Judetean de Urgenta Sf. Pantelimon Focsani
Focşani, Vrancea, 620165
Ploiesti Municipal Hospital
Ploieşti, Prahova, 100337
Ukraine6 sites
Municipal Institution City Clinical Hospital #4 of Dnipro City Council - PPDS
Dnipropetrovsk, 49102
Municipal Institution SubCarpathian ClinicalOncological Centre
Ivano-Frankivsk, 76018
MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council
Kryvyi Rih, 50048
Municipal non profit enterprise of Sumy Regional Council Sumy Regional Clinical Oncology Dispensary
Sumy, 40022
MNPE Central City Clinical Hospital of Uzhhorod City Council
Uzhhorod, 88000
MI of Zaporizhzhia Regional Council Zaporizhzhia Regional Clinical Oncology Dispensary
Zaporizhzhya, 69040
Belarus5 sites
Babruysk Interregional Oncological Dispensary
Babruysk, 213825
Grodno Clinical Regional Hospital
Grodno, Hrodzenskaya Voblasts, 230017
Mogilev Regional Oncology Dispensary
Minsk, Minsk Oblast, 220013
State Institution NN Alexandrov Republican Scientific and Practical Centre of Oncology And Medical R
Minsk, 223040
Grodno Clinical Regional Hospital
Mogilev, 212018
Hungary5 sites
Orszagos Koranyi Pulmonologiai Intezet
Budapest
Semmelweis Egyetem
Budapest
Debreceni Egyetem Klinikai Kozpont
Debrecen
Veszprem Megyei Tudogyogyintezet
Farkasgyepü
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktató Kórház
Miskolc
Bosnia and Herzegovina4 sites
Clinical Hospital Mostar
Mostar
Clinical Center University of Sarajevo
Sarajevo, 71000
Javna zdravstvena ustanova bolnica Trebinje
Trebinje, 89101
County Hospital Zenica
Zenica
Taiwan4 sites
Kaohsiung Medical University Hospital
Kaohsiung City, 807
E-DA hospital
Kaohsiung City, 82544
Taichung Veterans General Hospital
Taichung, 40705
Mackay Memorial Hospital-Taipei branch
Taipei, 10449
Vietnam4 sites
Bach Mai Hospital
Hanoi, 100000
National Cancer Hospital
Hanoi, 100000
National Lung Hospital
Hanoi, 100000
Cho Ray Hospital
Ho Chi Minh City, 700000
Croatia3 sites
Clinical Hospital Centre Osijek
Osijek, 31000
General Hospital Sibenik
Šibenik, 22000
Clinical Hospital Center Zagreb - PPDS
Zagreb, 10000
Bulgaria2 sites
Complex Oncology Center-Veliko Tarnovo
Veliko Tarnovo, 5000
Complex Oncology Center - Vratsa EOOD
Vratsa, 30001
Georgia2 sites
Research Institute of Clinical Medicine
Tbilisi, 112
LTD High Technology Medical Center University Clinic
Tbilisi, 144
Philippines2 sites
Philippine General Hospital
Manila, National Capital Region, 1000
Cardinal Santos Medical Center
San Juan City, National Capital Region, 1502
Poland2 sites
Med-Polonia Sp. z o.o.
Poznan, 60-693
Radomskie Centrum Onkologii
Radom, 26-600
Spain2 sites
Hospital Universitario Vall d'Hebrón - PPDS
Barcelona, 8035
Hospital Son Llatzer
Palma de Mallorca, 7198
Turkey (Türkiye)2 sites
Gazi University Medical Faculty Gazi Hospital
Ankara, 6500
Ege Universitesi Tip Fakultesi Hastanesi
Izmir, 35100
About this study
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
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
Read the 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
- Being tested
- Bevacizumab as MYL-1402O, Bevacizumab as Avastin
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab as MYL-1402OBiological
Bevacizumab as MYL-1402O 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV
Bevacizumab as AvastinBiological
Bevacizumab as Avastin 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV
| Study group | Role | What they receive |
|---|---|---|
| MYL-1402O | Experimental | 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. Receives: Biological: Bevacizumab as MYL-1402O |
| Avastin | Active comparator | 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. Receives: Biological: Bevacizumab as Avastin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 weeks after first dosing per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start21 Jan 2017
- Primary completion5 Jun 2019
- Study completion22 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for NSCLC Stage IVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, Double-Blind, Randomized, Parallel-Group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 671 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mylan Pharmaceuticals Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tazeen A Idris, MD, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04633564
- Sponsor's protocol ID
- MYL-1402O-3001
- Status last verified
- Mar 2022
- First submitted
- 2 Nov 2020
- Last updated
- 16 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04633564
- Acronym / sponsor ID
- MYL-1402O-3001
- Conditions
- NSCLC Stage IV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 671 participants (actual)
- Lead sponsor
- Mylan Pharmaceuticals IncIndustry (pharma, biotech, devices)
- Study start
- 21 Jan 2017 (actual)
- Primary completion
- 5 Jun 2019 (actual)
- Study completion
- 22 Nov 2019 (actual)
- First posted
- 18 Nov 2020 (actual)
- Results
- Posted 1 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multicenter, Double-Blind, Randomized, Parallel-Group
| Arm | Type | Receives |
|---|---|---|
| MYL-1402O | Experimental | Biological: Bevacizumab as MYL-1402OPatients 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 comparator | Biological: Bevacizumab as AvastinPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bevacizumab as MYL-1402OBevacizumab as MYL-1402O 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV | Biological | MYL-1402O |
| Bevacizumab as AvastinBevacizumab as Avastin 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV | Biological | Avastin |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tazeen A Idris, MD study director
102 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bevacizumab as MYL-1402O and Bevacizumab as Avastin in people with NSCLC Stage IV, run by Mylan Pharmaceuticals Inc at 102 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 102 sites in India, Russia, Romania, Ukraine, Belarus and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy Analysis of Overall Response Rate ( ORR) of MYL-1402O as Compared to Avastin (time frame: 18 weeks after first dosing per patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022.