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Carcinoma, Non-Small-Cell LungPhase 3AVANANCT02810457

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

A Phase 3 study testing FKB238 (bevacizumab), Avastin (bevacizumab) and Paclitaxel in people with Carcinoma, Non-Small-Cell Lung, run by Centus Biotherapeutics Limited at 147 sites in 24 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
FKB238 (bevacizumab), Avastin (bevacizumab) and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
731 participants
Where
147 sitesin 24 countries
Study dates
7 Sep 2016to 26 Jan 2022
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

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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.

Trial locations and contacts

147 sites in 24 countries.

147 sites in 24 countries

Russia27 sites

  • Research Site 6209

    Arkhangelsk, Arkhangelskaya oblast, 163045

  • Research Site 6221

    Belgorod, Belgorod Oblast, 308010

  • Research Site 6211

    Chelyabinsk, Chelyabinsk Oblast, 454087

  • Research Site 6229

    Izhevsk, Udmurtiya Republic, 426009

  • Research Site 6228

    Kursk, 305035

  • Research Site 6217

    Kuzmolovskiy, Leningradskaya Oblast', 188663

  • Research Site 6207

    Magnitogorsk, 455001

  • Research Site 6225

    Moscow, Moscow, 105229

  • Research Site 6203

    Moscow, Moscow, 143423

  • Research Site 6230

    Novgorod, Nizhny Novgorod Oblast, 603109

  • Research Site 6214

    Novosibirsk, Novosibirsk Oblast, 630007

  • Research Site 6213

    Novosibirsk, Novosibirsk Oblast, 630047

  • Research Site 6215

    Omsk, Omsk Oblast, 644013

  • Research Site 6224

    Omsk, Omsk Oblast, 644013

  • Research Site 6208

    Orenburg, Orenburg Oblast, 460021

  • Research Site 6223

    Rostov-on-Don, Rostov Oblast, 344037

  • Research Site 6205

    Ryazan, Ryazan Oblast, 390011

  • Research Site 6235

    Saint Petersburg, Sankt-Peterburg, 195271

  • Research Site 6212

    Saint Petersburg, Sankt-Peterburg, 197022

  • Research Site 6216

    Saint Petersburg, Sankt-Peterburg, 197342

  • Research Site 6202

    Saint Petersburg, Sankt-Peterburg, 197758

  • Research Site 6210

    Saint Petersburg, Sankt-Peterburg, 197758

  • Research Site 6201

    Saint Petersburg, Sankt-Peterburg, 198255

  • Research Site 6222

    Saint Petersburg, 198255

  • Research Site 6234

    Samara, Samara Oblast, 443031

  • Research Site 6219

    Saransk, Mordoviya, Respublika, 430032

  • Research Site 6220

    Ufa, Bashkortostan Republic, 450054

Other trials in Russia

United States11 sites

  • Research Site 7805 - Hematology & Oncology Associates, Inc.

    Canton, Ohio, 44708

  • Research Site 7801 - Gabrail Cancer Center

    Canton, Ohio, 44718

  • Research Site 7814 - Compassionate Care Research Group

    Fountain Valley, California, 92708

  • Research Site 7809 - Millennium Oncology

    Houston, Texas, 77090

  • Research Site 7803 - 21st Century Oncology

    Jacksonville, Florida, 32204

  • Research Site 7812 - Joliet Oncology-Hematology Associates, Ltd.

    Joliet, Illinois, 60435

  • Research Site 7804 - Tri-County Hematology & Oncology Associates, Inc.

    Massillon, Ohio, 44646

  • Research Site 7813 - Trinity Cancer Care Center

    Minot, North Dakota, 58701

  • Research Site 7806 - Vista Oncology Inc. PS

    Olympia, Washington, 98502

  • Research Site 7810 - Edward H. Kaplan, MD and Associates

    Skokie, Illinois, 60076

  • Research Site 7811 - Innovative Clinical Research Institute

    Whittier, California, 90603

Other trials in United States

Ukraine10 sites

  • Research Site 7702

    Chernivtsi, Chernivtsi Oblast, 58013

  • Research Site 7709

    Dnipro, 49102

  • Research Site 7701

    Ivano-Frankivsk, 76018

  • Research Site 7705

    Kharkiv, Kharkiv Oblast, 61070

  • Research Site 7708

    Kryvyi Rih, 50048

  • Research Site 7704

    Kyiv, 03115

  • Research Site 7713

    Lutsk, Volyn Oblast, 63000

  • Research Site 7706

    Odesa, Odesa Oblast, 65055

  • Research Site 7710

    Sumy, 40022

  • Research Site 7707

    Uzhhorod, Zakarpattia Oblast, 88000

Other trials in Ukraine

Spain8 sites

  • Research Site 7004

    A Coruña, A Coruña, 15009

  • Research Site 7001

    Burgos, 9006

  • Research Site 7002

    Castellon, Castellon, 12002

  • Research Site 7005

    Córdoba, Córdoba, 14004

  • Research Site 7009

    Jaén, Jaén, 23007

  • Research Site 7007

    Madrid, 28040

  • Research Site 7008

    Murcia, 30008

  • Research Site 7003

    Murcia, 30120

Other trials in Spain

Poland7 sites

  • Research Site 5711

    Brzozów, 36-200

  • Research Site 5702

    Elblag, Warmian-Masurian Voivodeship, 82-300

  • Research Site 5701

    Krakow, Lesser Poland Voivodeship, 31-826

  • Research Site 5708

    Lodz, Lódzkie, 93-513

  • Research Site 5703

    Nowy Sącz, 33-300

  • Research Site 5706

    Olsztyn, Warmian-Masurian Voivodeship, 10-357

  • Research Site 5705

    Toruniak, Kuyavian-Pomeranian Voivodeship, 87-100

Other trials in Poland

Romania7 sites

  • Research Site 6101

    Baia Mare, 430031

  • Research Site 6105

    Cluj-Napoca, Cluj, 400058

  • Research Site 6106

    Cluj-Napoca, Cluj, 400352

  • Research Site 6102

    Constanța, 900591

  • Research Site 6103

    Craiova, 200385

  • Research Site 6108

    Floreşti, Cluj, 407280

  • Research Site 6107

    Iași, 700106

Other trials in Romania

Thailand7 sites

  • Research Site 7506

    Bangkok, Bangkok, 10330

  • Research Site 7504

    Bangkok

  • Research Site 7507

    Chiang Mai, 50200

  • Research Site 7505

    Chiang Rai, 57000

  • Research Site 7501

    Hat Yai, Changwat Songkhla, 90110

  • Research Site 7503

    Khon Kaen, 40000

  • Research Site 7502

    Udon Thani, 41330

Other trials in Thailand

Belarus6 sites

  • Research Site 8507

    Brest, Brest Oblast, 224027

  • Research Site 8505

    Grodno, Hrodzenskaya Voblasts, 230017

  • Research Site 8501

    Lyasny, Minsk Oblast, 223040

  • Research Site 8504

    Minsk, Minsk Oblast, 220013

  • Research Site 8502

    Mogilev, Mogilyov Oblast, 212018

  • Research Site 8506

    Vitebsk, Vitebsk Oblast, 210603

Other trials in Belarus

Bosnia and Herzegovina6 sites

  • Research Site 8606

    Banja Luka, 78000

  • Research Site 8602

    Mostar, 88000

  • Research Site 8601

    Sarajevo, 71000

  • Research Site 8603

    Sarajevo, 71000

  • Research Site 8605

    Tuzla, Tuzlanski Kanton, 75000

  • Research Site 8604

    Zenica, 72000

Other trials in Bosnia and Herzegovina

Hungary6 sites

  • Research Site 3305

    Budapest, 1121

  • Research Site 3304

    Budapest

  • Research Site 3302

    Deszk, Csongrád megye, 6772

  • Research Site 3303

    Gyula, Bekes County, 5700

  • Research Site 3301

    Mátraháza, Heves County, 3233

  • Research Site 3306

    Zalaegerszeg, 8900

Other trials in Hungary

Philippines6 sites

  • Research Site 5505

    Cebu City, Cebu, 6000

  • Research Site 5504

    Makati City, National Capital Region, 1229

  • Research Site 5501

    Manila, National Capital Region, 1000

  • Research Site 5502

    Manila, National Capital Region, 1000

  • Research Site 5506

    Manila, National Capital Region, 1000

  • Research Site 5503

    Quezon, 1112

Other trials in Philippines

Serbia6 sites

  • Research Site 6402

    Belgrade, 11000

  • Research Site 6403

    Belgrade, 11000

  • Research Site 6404

    Belgrade, 11000

  • Research Site 6405

    Belgrade, 11070

  • Research Site 6401

    Kamenitz, Vojvodina, 21204

  • Research Site 6406

    Kragujevac, Šumadijski Okrug, 34000

Other trials in Serbia

Georgia5 sites

  • Research Site 2504

    Batumi, Adjara, 6010

  • Research Site 2507

    Kutaisi, Imereti, 4600

  • Research Site 2503

    Tbilisi, 0112

  • Research Site 2505

    Tbilisi, 0159

  • Research Site 2508

    Tbilisi, 0186

Other trials in Georgia

Peru4 sites

  • Research Site 5402

    Arequipa, 054

  • Research Site 5404

    Arequipa, 054

  • Research Site 5401

    Lima, 27

  • Research Site 5405

    Lima, 41

Other trials in Peru

South Korea4 sites

  • Research Site 6005

    Busan, Busan Gwang'yeogsi, 49241

  • Research Site 6002

    Seoul, Seoul Teugbyeolsi, 06973

  • Research Site 6004

    Suwon, Gyeonggido, 16247

  • Research Site 6003

    Ulsan, Ulsan Gwang'yeogsi, 44033

Other trials in South Korea

Taiwan4 sites

  • Research Site 7403

    Changhua, 500

  • Research Site 7404

    Douliu, Yunlin, 64041

  • Research Site 7402

    New Taipei City, Taipei, 231

  • Research Site 7401

    Taipei, 10449

Other trials in Taiwan

Turkey (Türkiye)4 sites

  • Research Site 7607

    Ankara, 06590

  • Research Site 7605

    Izmir, 35100

  • Research Site 7601

    Izmir, 35110

  • Research Site 7606

    Malatya, 44100

Other trials in Turkey (Türkiye)

Croatia3 sites

  • Research Site 1801

    Osijek, Osjecko-baranjska Županija, 31 000

  • Research Site 1802

    Zagreb, City of Zagreb, 10 000

  • Research Site 1803

    Zagreb, City of Zagreb, 10 000

Other trials in Croatia

Germany3 sites

  • Research Site 2604

    Hamburg, 22081

  • Research Site 2603

    Kiel, Schleswig-Holstein, 24105

  • Research Site 2605

    Würselen, North Rhine-Westphalia, 52146

Other trials in Germany

Greece3 sites

  • Research Site 3004

    Athens, 11527

  • Research Site 3003

    Thessaloniki, 56403

  • Research Site 3005

    Thessaloniki, 57010

Other trials in Greece

Japan3 sites

  • Research Site 4301

    Fukuyama-shi, Hiroshima

  • Research Site 4304

    Kumamoto, Kumamoto

  • Research Site 4303

    Sasebo-shi, Nagasaki

Other trials in Japan

Vietnam3 sites

  • Research Site 8401

    Hanoi, Ha Noi, Thu Do, 10000

  • Research Site 8402

    Hanoi, Ha Noi, Thu Do, 10000

  • Research Site 8405

    Hanoi, Ha Noi, Thu Do, 10000

Other trials in Vietnam

Bulgaria2 sites

  • Research Site 0905

    Sofia, Dobrich, 9300

  • Research Site 0904

    Varna, 9010

Other trials in Bulgaria

Italy2 sites

  • Research Site 4107

    Catania, 95126

  • Research Site 4106

    Piacenza, 29100

Other trials in Italy

About this study

Official title: 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

Being tested
FKB238 (bevacizumab), Avastin (bevacizumab), Paclitaxel, Carboplatin
Keywords
Cancer, Bevacizumab, Carboplatin, Paclitaxel
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02810457
Study groupRoleWhat they receive
FKB238 / paclitaxel / carboplatinExperimentalDrug: 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.
Receives: Drug: FKB238 (bevacizumab); Drug: Paclitaxel; Drug: Carboplatin
Avastin / paclitaxel / carboplatinActive comparatorDrug: 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.
Receives: Drug: Avastin (bevacizumab); Drug: Paclitaxel; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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 outcomes (5)

  1. 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.

    Measured: From the date of randomization up to Week 19.

  2. 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.

    Measured: 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.

  3. 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.

    Measured: 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.

  4. 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.

    Measured: 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.

  5. 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).

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2016 (estimated)
  2. Study start7 Sep 2016
  3. Primary completion24 Jan 2019
  4. Study completion26 Jan 2022

Resources

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
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
731 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02810457
Sponsor's protocol ID
FKB238-002
Other IDs
2015-004104-33, 2015
Acronym
AVANA
Status last verified
Feb 2022
First submitted
3 Jun 2016
Last updated
10 Mar 2022
Data monitoring committee
Yes

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.

    PubMed 34264503

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FKB238 (bevacizumab), Avastin (bevacizumab) and Paclitaxel in people with Carcinoma, Non-Small-Cell Lung, run by Centus Biotherapeutics Limited at 147 sites in 24 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 7 inclusion and 9 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 10 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 147 sites in Russia, United States, Ukraine, Spain, Poland and 19 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 19 Mar 2020). 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?

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) (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02810457, which also lists 1 linked publication.

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 10 Mar 2022.

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