Evaluation of FKB238 and Avastin in Patients With Advanced/Recurrent Non-squamous Non-small Cell Lung Cancer
NCT ID: NCT02810457
Last Updated: 2022-03-10
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
731 participants
INTERVENTIONAL
2016-09-07
2022-01-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study Comparing MB02 and Avastin® in Subjects With Stage IIIB/IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
NCT03296163
Avastin/Docetaxel/Carboplatin in Non-Small Cell Lung Cancer
NCT00271505
A Study of Bevacizumab Versus Placebo in Combination With Carboplatin/Paclitaxel in Participants With Advanced or Recurrent Non-Squamous Non-Small Cell Lung Cancer Who Have Not Received Previous Chemotherapy
NCT01364012
Carboplatin, Abraxane, and Bevacizumab in Previously Untreated Patients With Advanced Non-Small Cell Lung Cancer
NCT00642759
A Study of Avastin (Bevacizumab) in Combination With Platinum-Based Chemotherapy in Patients With Advanced or Recurrent Squamous Non-Small Cell Lung Cancer
NCT00404703
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
FKB238 / paclitaxel / carboplatin
Drug: FKB238:
15 mg/kg IV infusion on Day 1 of each 21-day cycle.
Drug: Paclitaxel:
200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
Drug: Carboplatin:
Area Under Curve (AUC) = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
FKB238 (bevacizumab)
Paclitaxel
Carboplatin
Avastin / paclitaxel / carboplatin
Drug: Avastin:
15 mg/kg IV infusion on Day 1 of each 21-day cycle.
Drug: Paclitaxel:
200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
Drug: Carboplatin:
AUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
Avastin (bevacizumab)
Paclitaxel
Carboplatin
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
FKB238 (bevacizumab)
Avastin (bevacizumab)
Paclitaxel
Carboplatin
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Newly diagnosed advanced (stage IV) /recurrent non-squamous NSCLC for which they had not received any systemic anti-cancer therapy for metastatic disease
* Histologically or cytologically confirmed diagnosis of predominantly non-squamous NSCLC
* Existence of at least 1 measurable lesion by RECIST v1.1
* Adequate hematological, renal and liver function
* Eastern Collaborative Oncology Group Performance Status (ECOG PS) 0 or 1
* Life expectancy longer than 6 months
Exclusion Criteria
* Any unresolved toxicities from prior systemic therapy
* Known sensitizing epidermal growth factor receptor (EGFR) mutations or echinoderm microtubule-associated protein-like 4-anaplastic lymphoma kinase (EML4-ALK) translocation positive mutations
* Previous dosing with vascular endothelial growth factor (VEGF) inhibitor
* Known hypersensitivity to any excipients of the Investigational Products (IPs) and combination chemotherapy
* Use of prohibited concomitant medication
* Known Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV) infection
* Fertile men or women of childbearing potential not using adequate contraception.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Centus Biotherapeutics Limited
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Centus Biotherapeutics Limited
Role: STUDY_DIRECTOR
Centus Biotherapeutics Limited
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site 7814 - Compassionate Care Research Group
Fountain Valley, California, United States
Research Site 7811 - Innovative Clinical Research Institute
Whittier, California, United States
Research Site 7803 - 21st Century Oncology
Jacksonville, Florida, United States
Research Site 7812 - Joliet Oncology-Hematology Associates, Ltd.
Joliet, Illinois, United States
Research Site 7810 - Edward H. Kaplan, MD and Associates
Skokie, Illinois, United States
Research Site 7813 - Trinity Cancer Care Center
Minot, North Dakota, United States
Research Site 7805 - Hematology & Oncology Associates, Inc.
Canton, Ohio, United States
Research Site 7801 - Gabrail Cancer Center
Canton, Ohio, United States
Research Site 7804 - Tri-County Hematology & Oncology Associates, Inc.
Massillon, Ohio, United States
Research Site 7809 - Millennium Oncology
Houston, Texas, United States
Research Site 7806 - Vista Oncology Inc. PS
Olympia, Washington, United States
Research Site 8507
Brest, Brest Oblast, Belarus
Research Site 8505
Grodno, Hrodzenskaya Voblasts, Belarus
Research Site 8501
Lyasny, Minsk Oblast, Belarus
Research Site 8504
Minsk, Minsk Oblast, Belarus
Research Site 8502
Mogilev, Mogilyov Oblast, Belarus
Research Site 8506
Vitebsk, Vitebsk Oblast, Belarus
Research Site 8605
Tuzla, Tuzlanski Kanton, Bosnia and Herzegovina
Research Site 8606
Banja Luka, , Bosnia and Herzegovina
Research Site 8602
Mostar, , Bosnia and Herzegovina
Research Site 8601
Sarajevo, , Bosnia and Herzegovina
Research Site 8603
Sarajevo, , Bosnia and Herzegovina
Research Site 8604
Zenica, , Bosnia and Herzegovina
Research Site 0905
Sofia, Dobrich, Bulgaria
Research Site 0904
Varna, , Bulgaria
Research Site 1802
Zagreb, City of Zagreb, Croatia
Research Site 1803
Zagreb, City of Zagreb, Croatia
Research Site 1801
Osijek, Osjecko-baranjska Županija, Croatia
Research Site 2504
Batumi, Adjara, Georgia
Research Site 2507
Kutaisi, Imereti, Georgia
Research Site 2503
Tbilisi, , Georgia
Research Site 2505
Tbilisi, , Georgia
Research Site 2508
Tbilisi, , Georgia
Research Site 2605
Würselen, North Rhine-Westphalia, Germany
Research Site 2603
Kiel, Schleswig-Holstein, Germany
Research Site 2604
Hamburg, , Germany
Research Site 3004
Athens, , Greece
Research Site 3003
Thessaloniki, , Greece
Research Site 3005
Thessaloniki, , Greece
Research Site 3303
Gyula, Bekes County, Hungary
Research Site 3302
Deszk, Csongrád megye, Hungary
Research Site 3301
Mátraháza, Heves County, Hungary
Research Site 3305
Budapest, , Hungary
Research Site 3304
Budapest, , Hungary
Research Site 3306
Zalaegerszeg, , Hungary
Research Site 4107
Catania, , Italy
Research Site 4106
Piacenza, , Italy
Research Site 4301
Fukuyama-shi, Hiroshima, Japan
Research Site 4304
Kumamoto, Kumamoto, Japan
Research Site 4303
Sasebo-shi, Nagasaki, Japan
Research Site 5402
Arequipa, , Peru
Research Site 5404
Arequipa, , Peru
Research Site 5401
Lima, , Peru
Research Site 5405
Lima, , Peru
Research Site 5505
Cebu City, Cebu, Philippines
Research Site 5504
Makati City, National Capital Region, Philippines
Research Site 5501
Manila, National Capital Region, Philippines
Research Site 5502
Manila, National Capital Region, Philippines
Research Site 5506
Manila, National Capital Region, Philippines
Research Site 5503
Quezon, , Philippines
Research Site 5705
Toruniak, Kuyavian-Pomeranian Voivodeship, Poland
Research Site 5701
Krakow, Lesser Poland Voivodeship, Poland
Research Site 5708
Lodz, Lódzkie, Poland
Research Site 5702
Elblag, Warmian-Masurian Voivodeship, Poland
Research Site 5706
Olsztyn, Warmian-Masurian Voivodeship, Poland
Research Site 5711
Brzozów, , Poland
Research Site 5703
Nowy Sącz, , Poland
Research Site 6105
Cluj-Napoca, Cluj, Romania
Research Site 6106
Cluj-Napoca, Cluj, Romania
Research Site 6108
Floreşti, Cluj, Romania
Research Site 6101
Baia Mare, , Romania
Research Site 6102
Constanța, , Romania
Research Site 6103
Craiova, , Romania
Research Site 6107
Iași, , Romania
Research Site 6209
Arkhangelsk, Arkhangelskaya oblast, Russia
Research Site 6220
Ufa, Bashkortostan Republic, Russia
Research Site 6221
Belgorod, Belgorod Oblast, Russia
Research Site 6211
Chelyabinsk, Chelyabinsk Oblast, Russia
Research Site 6217
Kuzmolovskiy, Leningradskaya Oblast', Russia
Research Site 6219
Saransk, Mordoviya, Respublika, Russia
Research Site 6225
Moscow, Moscow, Russia
Research Site 6203
Moscow, Moscow, Russia
Research Site 6230
Novgorod, Nizhny Novgorod Oblast, Russia
Research Site 6214
Novosibirsk, Novosibirsk Oblast, Russia
Research Site 6213
Novosibirsk, Novosibirsk Oblast, Russia
Research Site 6215
Omsk, Omsk Oblast, Russia
Research Site 6224
Omsk, Omsk Oblast, Russia
Research Site 6208
Orenburg, Orenburg Oblast, Russia
Research Site 6223
Rostov-on-Don, Rostov Oblast, Russia
Research Site 6205
Ryazan, Ryazan Oblast, Russia
Research Site 6234
Samara, Samara Oblast, Russia
Research Site 6235
Saint Petersburg, Sankt-Peterburg, Russia
Research Site 6212
Saint Petersburg, Sankt-Peterburg, Russia
Research Site 6216
Saint Petersburg, Sankt-Peterburg, Russia
Research Site 6202
Saint Petersburg, Sankt-Peterburg, Russia
Research Site 6210
Saint Petersburg, Sankt-Peterburg, Russia
Research Site 6201
Saint Petersburg, Sankt-Peterburg, Russia
Research Site 6229
Izhevsk, Udmurtiya Republic, Russia
Research Site 6228
Kursk, , Russia
Research Site 6207
Magnitogorsk, , Russia
Research Site 6222
Saint Petersburg, , Russia
Research Site 6401
Kamenitz, Vojvodina, Serbia
Research Site 6402
Belgrade, , Serbia
Research Site 6403
Belgrade, , Serbia
Research Site 6404
Belgrade, , Serbia
Research Site 6405
Belgrade, , Serbia
Research Site 6406
Kragujevac, Šumadijski Okrug, Serbia
Research Site 6005
Busan, Busan Gwang'yeogsi, South Korea
Research Site 6004
Suwon, Gyeonggido, South Korea
Research Site 6002
Seoul, Seoul Teugbyeolsi, South Korea
Research Site 6003
Ulsan, Ulsan Gwang'yeogsi, South Korea
Research Site 7004
A Coruña, A Coruña, Spain
Research Site 7002
Castellon, Castellon, Spain
Research Site 7005
Córdoba, Córdoba, Spain
Research Site 7009
Jaén, Jaén, Spain
Research Site 7001
Burgos, , Spain
Research Site 7007
Madrid, , Spain
Research Site 7008
Murcia, , Spain
Research Site 7003
Murcia, , Spain
Research Site 7402
New Taipei City, Taipei, Taiwan
Research Site 7404
Douliu, Yunlin, Taiwan
Research Site 7403
Changhua, , Taiwan
Research Site 7401
Taipei, , Taiwan
Research Site 7506
Bangkok, Bangkok, Thailand
Research Site 7501
Hat Yai, Changwat Songkhla, Thailand
Research Site 7504
Bangkok, , Thailand
Research Site 7507
Chiang Mai, , Thailand
Research Site 7505
Chiang Rai, , Thailand
Research Site 7503
Khon Kaen, , Thailand
Research Site 7502
Udon Thani, , Thailand
Research Site 7607
Ankara, , Turkey (Türkiye)
Research Site 7605
Izmir, , Turkey (Türkiye)
Research Site 7601
Izmir, , Turkey (Türkiye)
Research Site 7606
Malatya, , Turkey (Türkiye)
Research Site 7702
Chernivtsi, Chernivtsi Oblast, Ukraine
Research Site 7705
Kharkiv, Kharkivs’ka Oblast’, Ukraine
Research Site 7706
Odesa, Odesa Oblast, Ukraine
Research Site 7713
Lutsk, Volyn Oblast, Ukraine
Research Site 7707
Uzhhorod, Zakarpattia Oblast, Ukraine
Research Site 7709
Dnipro, , Ukraine
Research Site 7701
Ivano-Frankivsk, , Ukraine
Research Site 7708
Kryvyi Rih, , Ukraine
Research Site 7704
Kyiv, , Ukraine
Research Site 7710
Sumy, , Ukraine
Research Site 8401
Hanoi, Ha Noi, Thu Do, Vietnam
Research Site 8402
Hanoi, Ha Noi, Thu Do, Vietnam
Research Site 8405
Hanoi, Ha Noi, Thu Do, Vietnam
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Syrigos K, Abert I, Andric Z, Bondarenko IN, Dvorkin M, Galic K, Galiulin R, Kuchava V, Sriuranpong V, Trukhin D, Zhavrid E, Fu D, Kassalow LM, Jones S, Bashir Z; AVANA Investigators. Efficacy and Safety of Bevacizumab Biosimilar FKB238 Versus Originator Bevacizumab: Results from AVANA, a Phase III Trial in Patients with Non-Squamous Non-Small-Cell Lung Cancer (non-sq-NSCLC). BioDrugs. 2021 Jul;35(4):417-428. doi: 10.1007/s40259-021-00489-4. Epub 2021 Jul 15.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2015-004104-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
FKB238-002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.