Evaluation of FKB238 and Avastin in Patients With Advanced/Recurrent Non-squamous Non-small Cell Lung Cancer (AVANA)

A Randomised, Parallel, Double Blinded Study to Compare the Efficacy and Safety of FKB238 to Avastin® In 1st Line Treatment for Patients With Advanced/Recurrent Non Squamous NSCLC in Combination of Paclitaxel and Carboplatin

The purpose of this research study is to compare the effectiveness and safety of FKB238 against Avastin® in men and women with advanced/recurrent non squamous non-small cell lung cancer

Study Overview

• Status: Completed
• Conditions: Carcinoma, Non-Small-Cell Lung
• Intervention / Treatment: Drug: Carboplatin; Drug: Paclitaxel; Drug: Avastin (bevacizumab); Drug: FKB238 (bevacizumab)

• Study Type: Interventional
• Enrollment (Actual): 731
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belarus
  • Brestskaya Voblasts
    • Brest, Brestskaya Voblasts, Belarus, 224027
      • Research Site 8507
  • Hrodzenskaya Voblasts
    • Grodno, Hrodzenskaya Voblasts, Belarus, 230017
      • Research Site 8505
  • Mahilyowskaya Voblasts
    • Mogilev, Mahilyowskaya Voblasts, Belarus, 212018
      • Research Site 8502
  • Minskaya Voblasts
    • Lesnoy, Minskaya Voblasts, Belarus, 223040
      • Research Site 8501
    • Minsk, Minskaya Voblasts, Belarus, 220013
      • Research Site 8504
  • Vitsyebskaya Voblasts
    • Vitebsk, Vitsyebskaya Voblasts, Belarus, 210603
      • Research Site 8506
• Bosnia and Herzegovina
  • Banja Luka, Bosnia and Herzegovina, 78000
    • Research Site 8606
  • Mostar, Bosnia and Herzegovina, 88000
    • Research Site 8602
  • Sarajevo, Bosnia and Herzegovina, 71000
    • Research Site 8601
  • Sarajevo, Bosnia and Herzegovina, 71000
    • Research Site 8603
  • Zenica, Bosnia and Herzegovina, 72000
    • Research Site 8604
  • Tuzlanski Kanton
    • Tuzla, Tuzlanski Kanton, Bosnia and Herzegovina, 75000
      • Research Site 8605
• Bulgaria
  • Varna, Bulgaria, 9010
    • Research Site 0904
  • Dobrich
    • Sofia, Dobrich, Bulgaria, 9300
      • Research Site 0905
• Croatia
  • Grad Zagreb
    • Zagreb, Grad Zagreb, Croatia, 10 000
      • Research Site 1802
    • Zagreb, Grad Zagreb, Croatia, 10 000
      • Research Site 1803
  • Osjecko-baranjska Županija
    • Osijek, Osjecko-baranjska Županija, Croatia, 31 000
      • Research Site 1801
• Georgia
  • Tbilisi, Georgia, 0112
    • Research Site 2503
  • Tbilisi, Georgia, 0159
    • Research Site 2505
  • Tbilisi, Georgia, 0186
    • Research Site 2508
  • Ajaria
    • Bat'umi, Ajaria, Georgia, 6010
      • Research Site 2504
  • Imereti
    • Kutaisi, Imereti, Georgia, 4600
      • Research Site 2507
• Germany
  • Hamburg, Germany, 22081
    • Research Site 2604
  • Nordrhein-Westfalen
    • Würselen, Nordrhein-Westfalen, Germany, 52146
      • Research Site 2605
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • Research Site 2603
• Greece
  • Athens, Greece, 11527
    • Research Site 3004
  • Thessaloniki, Greece, 56403
    • Research Site 3003
  • Thessaloníki, Greece, 57010
    • Research Site 3005
• Hungary
  • Budapest, Hungary, 1121
    • Research Site 3305
  • Budapest, Hungary
    • Research Site 3304
  • Zalaegerszeg, Hungary, 8900
    • Research Site 3306
  • Békés
    • Gyula, Békés, Hungary, 5700
      • Research Site 3303
  • Csongrád
    • Deszk, Csongrád, Hungary, 6772
      • Research Site 3302
  • Heves
    • Mátraháza, Heves, Hungary, 3233
      • Research Site 3301
• Italy
  • Catania, Italy, 95126
    • Research Site 4107
  • Piacenza, Italy, 29100
    • Research Site 4106
• Japan
  • Hiroshima
    • Fukuyama-shi, Hiroshima, Japan
      • Research Site 4301
  • Kumamoto
    • Kumamoto-shi, Kumamoto, Japan
      • Research Site 4304
  • Nagasaki
    • Sasebo-shi, Nagasaki, Japan
      • Research Site 4303
• Korea, Republic of
  • Busan Gwang'yeogsi
    • Busan, Busan Gwang'yeogsi, Korea, Republic of, 49241
      • Research Site 6005
  • Gyeonggido
    • Suwon-si, Gyeonggido, Korea, Republic of, 16247
      • Research Site 6004
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06973
      • Research Site 6002
  • Ulsan Gwang'yeogsi
    • Ulsan, Ulsan Gwang'yeogsi, Korea, Republic of, 44033
      • Research Site 6003
• Peru
  • Arequipa, Peru, 054
    • Research Site 5402
  • Arequipa, Peru, 054
    • Research Site 5404
  • Lima, Peru, 27
    • Research Site 5401
  • Lima, Peru, 41
    • Research Site 5405
• Philippines
  • Quezon, Philippines, 1112
    • Research Site 5503
  • Cebu
    • Cebu City, Cebu, Philippines, 6000
      • Research Site 5505
  • National Capital Region
    • Makati City, National Capital Region, Philippines, 1229
      • Research Site 5504
    • Manila, National Capital Region, Philippines, 1000
      • Research Site 5501
    • Manila, National Capital Region, Philippines, 1000
      • Research Site 5502
    • Manila, National Capital Region, Philippines, 1000
      • Research Site 5506
• Poland
  • Brzozów, Poland, 36-200
    • Research Site 5711
  • Nowy Sacz, Poland, 33-300
    • Research Site 5703
  • Kujawsko-pomorskie
    • Toruniak, Kujawsko-pomorskie, Poland, 87-100
      • Research Site 5705
  • Lódzkie
    • Lodz, Lódzkie, Poland, 93-513
      • Research Site 5708
  • Malopolskie
    • Krakow, Malopolskie, Poland, 31-826
      • Research Site 5701
  • Warminsko-mazurskie
    • Elblag, Warminsko-mazurskie, Poland, 82-300
      • Research Site 5702
    • Olsztyn, Warminsko-mazurskie, Poland, 10-357
      • Research Site 5706
• Romania
  • Baia Mare, Romania, 430031
    • Research Site 6101
  • Constanta, Romania, 900591
    • Research Site 6102
  • Craiova, Romania, 200385
    • Research Site 6103
  • Iasi, Romania, 700106
    • Research Site 6107
  • Cluj
    • Cluj-Napoca, Cluj, Romania, 400058
      • Research Site 6105
    • Cluj-Napoca, Cluj, Romania, 400352
      • Research Site 6106
    • Floreşti, Cluj, Romania, 407280
      • Research Site 6108
• Russian Federation
  • Kursk, Russian Federation, 305035
    • Research Site 6228
  • Magnitogorsk, Russian Federation, 455001
    • Research Site 6207
  • Saint Petersburg, Russian Federation, 198255
    • Research Site 6222
  • Arkhangel'skaya Oblast'
    • Arkhangelsk, Arkhangel'skaya Oblast', Russian Federation, 163045
      • Research Site 6209
  • Bashkortostan, Respublika
    • Ufa, Bashkortostan, Respublika, Russian Federation, 450054
      • Research Site 6220
  • Belgorodskaya Oblast'
    • Belgorod, Belgorodskaya Oblast', Russian Federation, 308010
      • Research Site 6221
  • Chelyabinskaya Oblast'
    • Chelyabinsk, Chelyabinskaya Oblast', Russian Federation, 454087
      • Research Site 6211
  • Leningradskaya Oblast'
    • Kuzmolovskiy, Leningradskaya Oblast', Russian Federation, 188663
      • Research Site 6217
  • Mordoviya, Respublika
    • Saransk, Mordoviya, Respublika, Russian Federation, 430032
      • Research Site 6219
  • Moskva
    • Moscow, Moskva, Russian Federation, 105229
      • Research Site 6225
    • Moscow, Moskva, Russian Federation, 143423
      • Research Site 6203
  • Nizhegorodskaya Oblast'
    • Novgorod, Nizhegorodskaya Oblast', Russian Federation, 603109
      • Research Site 6230
  • Novosibirskaya Oblast'
    • Novosibirsk, Novosibirskaya Oblast', Russian Federation, 630007
      • Research Site 6214
    • Novosibirsk, Novosibirskaya Oblast', Russian Federation, 630047
      • Research Site 6213
  • Omskaya Oblast'
    • Omsk, Omskaya Oblast', Russian Federation, 644013
      • Research Site 6215
    • Omsk, Omskaya Oblast', Russian Federation, 644013
      • Research Site 6224
  • Orenburgskaya Oblast'
    • Orenburg, Orenburgskaya Oblast', Russian Federation, 460021
      • Research Site 6208
  • Rostovskaya Oblast'
    • Rostov-on-Don, Rostovskaya Oblast', Russian Federation, 344037
      • Research Site 6223
  • Ryazanskaya Oblast'
    • Ryazan', Ryazanskaya Oblast', Russian Federation, 390011
      • Research Site 6205
  • Samarskaya Oblast'
    • Samara, Samarskaya Oblast', Russian Federation, 443031
      • Research Site 6234
  • Sankt-Peterburg
    • Saint Petersburg, Sankt-Peterburg, Russian Federation, 195271
      • Research Site 6235
    • Saint Petersburg, Sankt-Peterburg, Russian Federation, 197022
      • Research Site 6212
    • Saint Petersburg, Sankt-Peterburg, Russian Federation, 197342
      • Research Site 6216
    • Saint Petersburg, Sankt-Peterburg, Russian Federation, 198255
      • Research Site 6201
    • Sankt Petersburg, Sankt-Peterburg, Russian Federation, 197758
      • Research Site 6202
    • Sankt Petersburg, Sankt-Peterburg, Russian Federation, 197758
      • Research Site 6210
  • Udmurtskaya Respublika
    • Izhevsk, Udmurtskaya Respublika, Russian Federation, 426009
      • Research Site 6229
• Serbia
  • Belgrade, Serbia, 11000
    • Research Site 6402
  • Belgrade, Serbia, 11000
    • Research Site 6403
  • Belgrade, Serbia, 11000
    • Research Site 6404
  • Belgrade, Serbia, 11070
    • Research Site 6405
  • Vojvodina
    • Sremska Kamenica, Vojvodina, Serbia, 21204
      • Research Site 6401
  • Šumadijski Okrug
    • Kragujevac, Šumadijski Okrug, Serbia, 34000
      • Research Site 6406
• Spain
  • Burgos, Spain, 9006
    • Research Site 7001
  • Madrid, Spain, 28040
    • Research Site 7007
  • Murcia, Spain, 30008
    • Research Site 7008
  • Murcia, Spain, 30120
    • Research Site 7003
  • A Coruña
    • A Coruna, A Coruña, Spain, 15009
      • Research Site 7004
  • Castellon
    • Castellón De La Plana, Castellon, Spain, 12002
      • Research Site 7002
  • Córdoba
    • Cordoba, Córdoba, Spain, 14004
      • Research Site 7005
  • Jaén
    • Jaen, Jaén, Spain, 23007
      • Research Site 7009
• Taiwan
  • Changhua, Taiwan, 500
    • Research Site 7403
  • Taipei, Taiwan, 10449
    • Research Site 7401
  • Taipei
    • New Taipei City, Taipei, Taiwan, 231
      • Research Site 7402
  • Yunlin
    • Douliu, Yunlin, Taiwan, 64041
      • Research Site 7404
• Thailand
  • Bangkok, Thailand
    • Research Site 7504
  • Chiang Mai, Thailand, 50200
    • Research Site 7507
  • Chiang Rai, Thailand, 57000
    • Research Site 7505
  • Khon Kaen, Thailand, 40000
    • Research Site 7503
  • Udon Thani, Thailand, 41330
    • Research Site 7502
  • Krung Thep Maha Nakhon
    • Bangkok, Krung Thep Maha Nakhon, Thailand, 10330
      • Research Site 7506
  • Songkhla
    • Hat Yai, Songkhla, Thailand, 90110
      • Research Site 7501
• Turkey
  • Ankara, Turkey, 06590
    • Research Site 7607
  • Izmir, Turkey, 35110
    • Research Site 7601
  • Malatya, Turkey, 44100
    • Research Site 7606
  • İzmir, Turkey, 35100
    • Research Site 7605
• Ukraine
  • Dnipropetrovs'k, Ukraine, 49102
    • Research Site 7709
  • Ivano-Frankivs'k, Ukraine, 76018
    • Research Site 7701
  • Kryvyi Rih, Ukraine, 50048
    • Research Site 7708
  • Kyiv, Ukraine, 03115
    • Research Site 7704
  • Sumy, Ukraine, 40022
    • Research Site 7710
  • Chernivets'ka Oblast'
    • Chernivtsi, Chernivets'ka Oblast', Ukraine, 58013
      • Research Site 7702
  • Kharkivs'ka Oblast'
    • Kharkiv, Kharkivs'ka Oblast', Ukraine, 61070
      • Research Site 7705
  • Odes'ka Oblast'
    • Odesa, Odes'ka Oblast', Ukraine, 65055
      • Research Site 7706
  • Volyns'ka Oblast'
    • Lutsk, Volyns'ka Oblast', Ukraine, 63000
      • Research Site 7713
  • Zakarpats'ka Oblast'
    • Uzhgorod, Zakarpats'ka Oblast', Ukraine, 88000
      • Research Site 7707
• United States
  • California
    • Fountain Valley, California, United States, 92708
      • Research Site 7814 - Compassionate Care Research Group
    • Whittier, California, United States, 90603
      • Research Site 7811 - Innovative Clinical Research Institute
  • Florida
    • Jacksonville, Florida, United States, 32204
      • Research Site 7803 - 21st Century Oncology
  • Illinois
    • Joliet, Illinois, United States, 60435
      • Research Site 7812 - Joliet Oncology-Hematology Associates, Ltd.
    • Skokie, Illinois, United States, 60076
      • Research Site 7810 - Edward H. Kaplan, MD and Associates
  • North Dakota
    • Minot, North Dakota, United States, 58701
      • Research Site 7813 - Trinity Cancer Care Center
  • Ohio
    • Canton, Ohio, United States, 44708
      • Research Site 7805 - Hematology & Oncology Associates, Inc.
    • Canton, Ohio, United States, 44718
      • Research Site 7801 - Gabrail Cancer Center
    • Massillon, Ohio, United States, 44646
      • Research Site 7804 - Tri-County Hematology & Oncology Associates, Inc.
  • Texas
    • Houston, Texas, United States, 77090
      • Research Site 7809 - Millennium Oncology
  • Washington
    • Olympia, Washington, United States, 98502
      • Research Site 7806 - Vista Oncology Inc. PS
• Vietnam
  • Ha Noi, Thu Do
    • Hanoi, Ha Noi, Thu Do, Vietnam, 10000
      • Research Site 8401
    • Hanoi, Ha Noi, Thu Do, Vietnam, 10000
      • Research Site 8402
    • Hanoi, Ha Noi, Thu Do, Vietnam, 10000
      • Research Site 8405

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients aged 18 years or older
• 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:

• Small cell lung cancer (SCLC) or combination SCLC and NSCLC. Squamous-cell tumors and mixed adenosquamous carcinomas of predominantly squamous nature
• 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.

Other inclusion/exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Carboplatin; Drug: Paclitaxel; Drug: FKB238 (bevacizumab)
Active Comparator: 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.	Drug: Carboplatin; Drug: Paclitaxel; Drug: Avastin (bevacizumab)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate (ORR) Assessed as the Proportion of Patients With a Best Overall Response (BOR) of Either Complete Response (CR) or Partial Response (PR)	The primary variable in this study was ORR, defined as the proportion of patients with a BOR of CR or PR (by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)). A BOR was defined as the best response (in the order of CR, PR, stable disease (SD), no evidence of disease (NED), progressive disease (PD), and not evaluable (NE)) among all post-baseline disease assessments that occurred until progression, or last evaluable assessment in the absence of progression prior to the initiation of subsequent anti-cancer therapy, irrespective of whether or not patients discontinued the study treatment. The 95% Pearson-Clopper confidence interval (CI) of ORR for each treatment arm was provided. Per RECIST v1.1 for target lesions and assessed by computed tomography (CT) or, if contraindicated, magnetic resonance imaging (MRI): CR=disappearance of all target lesions; PR=at least 30% decrease from baseline in the sum of diameters of target lesions. Overall Response=CR+PR.	Until data cut-off, which occurred 12 months after randomization of the last patient enrolled, for a total estimated period of time of up to approximately 30 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR at Week 19	ORR (by RECIST v1.1) at Week 19 was defined as the proportion of patients with a BOR of CR or PR assessed at Week 19. Only tumor assessments performed up until 19 weeks (i.e. Week 18 assessment + 7 day assessment window) from randomization were considered in this analysis. Per RECIST v1.1 for target lesions and assessed by CT or, if contraindicated, MRI: CR=disappearance of all target lesions; PR=at least 30% decrease from baseline in the sum of diameters of target lesions. Overall Response=CR+PR.	From the date of randomization up to Week 19.
Progression-free Survival (PFS)	The event of interest for PFS was defined as the interval from the date of randomization until first documented disease progression or death from any cause, whichever occurs first. Disease progression was based on tumor assessments according to RECIST v1.1 criteria. The items of the overall response CR, PR, SD and NED were taken as progression-free whereas PD denoted disease progression. PFS was summarized using Kaplan-Meier estimates of the quartiles for each treatment arm, and 95% CIs for the medians were calculated. Per RECIST v1.1 for target lesions and assessed by CT or, if contraindicated, MRI: PD=at least a 20% increase in the sum of the longest diameter of target lesions, unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.	Until data cut-off, which occurred 12 months after randomization of the last patient enrolled, for a total estimated period of time of up to approximately 30 months.
Overall Survival (OS)	The event of interest was defined as death from any cause. OS was defined as the interval from date of randomization until the date of death due to any cause. OS was summarized using Kaplan-Meier estimates of the quartiles for each treatment arm, and 95% CIs for the medians were calculated.	Until data cut-off, which occurred 12 months after randomization of the last patient enrolled, for a total estimated period of time of up to approximately 30 months.
Duration Of Response (DOR)	DOR was evaluated in this study as a secondary efficacy endpoint. Only the patients defined as responders in the primary analysis of ORR were taken into account for the analysis of DOR. The event of interest was defined as first documented disease progression or death due to any reason, whichever occurred first. DOR was defined as the interval from the first documented response (as defined per RECIST v1.1) until the earlier date of the first documented disease progression or death due to any reason. The date of first documented response was taken as the date of the first tumor assessment with an overall visit response of CR or PR. Per RECIST v1.1 for target lesions and assessed by CT or, if contraindicated, MRI: CR=disappearance of all target lesions; PR=at least 30% decrease from baseline in the sum of diameters of target lesions. DOR was calculated in units of months.	Until data cut-off, which occurred 12 months after randomization of the last patient enrolled, for a total estimated period of time of up to approximately 30 months.
Disease Control Rate (DCR) Assessed as the Proportion of Patients With a BOR of Either CR, PR, SD or NED	The DCR was defined as the proportion of patients defined as responders. The number and percentage of responders and non-responders and the 95% Pearson-Clopper CI of DCR for each treatment arm was provided. The odds ratio for treatment (FKB238 arm versus Avastin arm) and the corresponding 95% Wald CI were produced based on a logistic regression analysis of DCR. Per RECIST v1.1 for target lesions and assessed by CT or, if contraindicated, MRI: CR=disappearance of all target lesions; PR=at least 30% decrease from baseline in the sum of diameters of target lesions; SD=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study. DCR=CR+PR+SD (≥ 6 weeks).	Until data cut-off, which occurred 12 months after randomization of the last patient enrolled, for a total estimated period of time of up to approximately 30 months.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Trough Concentration (Ctrough)	Ctrough (pre-infusion) and serum maximum concentration (Cmax; at completion of infusion) were compared between treatment arms and time points, and descriptive statistics provided. Ctrough and Cmax concentrations were summarized using the pharmacokinetics (PK) population for each visit at which samples were taken. The pre-dose serum concentrations at Cycles 2, 4, and 6 were considered as Ctrough values and the post-dose serum concentrations at Cycles 1 and 4 were considered as Cmax values. PK data at Cycle 1 Day 1 pre-infusion were not calculable and are therefore not presented in the outcome measure data table. Data are only provided for the time points at which the serum trough concentration was measured.	Cycle 1 Day 1 (pre- and post-infusion), Cycle 2 Day 1 (pre), Cycle 4 Day 1 (pre and post), Cycle 6 Day 1 (pre), discontinuation visit, and every 12 weeks (up to 1 year [±14 days] after randomisation) until death, or the patient was lost to follow-up.
Proportion of Patients Developing Anti-drug Antibodies (ADAs)	The ADA levels were summarized at baseline and post-baseline time points using descriptive statistics.	Pre-dose at Cycles 1, 2, 4 and 6, discontinuation visit, and every 12 weeks (up to 1 year [±14 days] after randomisation) until death, or the patient was lost to follow-up, whichever occurred first.
Adverse Events (AEs)		From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months.
Vital Signs		Up to approximately 30 days after last dose of study treatment.
Hematology		Up to approximately 30 days after last dose of study treatment.
Clinical Chemistry		Up to approximately 30 days after last dose of study treatment.
Urinalysis		Up to approximately 30 days after last dose of study treatment.
Electrocardiogram		Up to approximately 30 days after last dose of study treatment.
Eastern Collaborative Oncology Group Performance Status		Up to approximately 30 days after last dose of study treatment.
Physical Examination		Up to approximately 30 days after last dose of study treatment.

Collaborators and Investigators

• Sponsor: Centus Biotherapeutics Limited
• Investigators: Study Director: Centus Biotherapeutics Limited, Centus Biotherapeutics Limited

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2016
• Primary Completion (Actual): January 24, 2019
• Study Completion (Actual): January 26, 2022

Study Registration Dates

• First Submitted: June 3, 2016
• First Submitted That Met QC Criteria: June 20, 2016
• First Posted (Estimate): June 23, 2016

Study Record Updates

• Last Update Posted (Actual): March 10, 2022
• Last Update Submitted That Met QC Criteria: February 25, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Cancer; Bevacizumab; Carboplatin; Paclitaxel
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Carboplatin; Paclitaxel; Bevacizumab
• Other Study ID Numbers: FKB238-002; 2015-004104-33 (EudraCT Number)