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Non-small Cell Lung CancerPhase 3NCT01763645

A Safety and Efficacy Study of BCD-021 With Paclitaxel and Carboplatin Compared to Avastin With Paclitaxel and Carboplatin in Non-Small Cell Lung Cancer

A Phase 3 study testing Bevacizumab, Paclitaxel and Carboplatin in people with Non-small Cell Lung Cancer, run by Biocad at 44 sites in 4 countries.

Completed

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

Official record
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Trial summary

BCD-021-02 is a double-blind randomized clinical trial comparing efficacy of BCD-021 (INN: bevacizumab) and paclitaxel + carboplatin to Avastin and paclitaxel + carboplatin in inoperable or advanced non-squamous NSCLC patients with pharmacokinetics substudy. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
Bevacizumab, Paclitaxel and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
353 participants
Where
44 sitesin 4 countries
Study dates
Oct 2012to Nov 2014
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent;
  • Newly diagnosed histologically or cytologically confirmed NSCLC excluding squamous NSCLC (mixed cancer types should be classified according to the prevalent cell type);
  • IIIb or IV stage of NSCLC (TNM classification version 6);
  • Age ≥ 18 years and age ≤ 75 years (both inclusive);
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2, (not declining within 2 weeks prior to the first dose of investigational product);
  • Life expectancy - 12 weeks or more from the moment of randomization;
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  • Presence of at least 1 measurable tumour with a size not less than 1 cm (revealed with CT slice thickness not more than 5 mm), as defined by modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria (specifically, no ascites, pleural, or pericardial effusions, osteoblastic bone metastases, or carcinomatous lymphangitis of the lung as only lesion;
  • Patients should be able to follow the Protocol procedures (according to Investigator's assessment);
  • Patients must implement reliable contraceptive measures during all the study treatment, starting 4 weeks prior to the administration of the first dose of investigational product until 6 months after the last dose of investigational product. This requirement does not apply to participants who have undergone surgical sterilization, or patients who are postmenopausal (documented) for the past 2 years. Reliable contraceptive measures include two methods of contraception, including one barrier method

Who cannot join

  • Squamous NSCLC;
  • Proven coagulopathy, clinically significant hemorrhage in the past including nasal hemorrhage;
  • absolute neutrophil count <1500/mm3;
  • Platelets <100 000/mm3;
  • Hemoglobin < 90 g/L;
  • Creatinine level ≥1.5 mg/dL;
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  • Bilirubin level ≥1.5 × upper limit of normal (ULN);
  • Aspartate-aminotransferase(AST) and alanine-aminotransferase (ALT) levels ≥2.5 × ULN (≥5 × ULN for patients with liver metastases);
  • Alkaline phosphatase level ≥5 × ULN;
  • Current therapeutic anticoagulation treatment, aspirin (more than 325 mg/day), nonsteroidal anti-inflammatory drugs, antiplatelet agents or protracted treatment with these drugs less than 1 month before entering the study;
  • Uncontrolled hypertension comprising all cases of arterial hypertension when no decrease in blood pressure could be achieved despite treatment with a combination of 3 antihypertensive drugs including one diuretic and non-medical correction methods (low salt diet, physical exercise);
  • Any previous anticancer therapy (chemotherapy, radiation therapy , surgery etc.) of metastatic NSCLC;
  • Radiation or hormone therapy within 21 days prior to randomization;
  • Major surgery 28 days before inclusion into the study;
  • Previous antiangiogenic therapy;
  • Hypersensitivity to taxanes, platinum agents, recombinant murine proteins, contrast agents, premedication agents specified by Protocol (dexamethasone, diphenhydramine, ranitidine) or excipients of investigational products;
  • NSCLC metastases in central nervous system excluding metastases non-progressing without glucocorticosteroids within 4 weeks before inclusion into the trial;
  • Cardiovascular system pathology (CHF stage III-IV according to New York Heart Association (NYHA) classification);
  • Pregnancy or lactation;
  • Conditions limiting patient's adherence to Protocol requirements (dementia, neurologic or psychiatric disorders, drug addiction, alcoholism and others);
  • Stage II-IV neuropathy according to Common Terminology Criteria for Adverse Events (CTCAE) v.4.0;
  • Simultaneous participation in other clinical trials, previous participation in other clinical trials within 30 days before entering into the trial, previous participation in the same trial;
  • Any other concomitant cancer revealed within 5 years prior to screening, except curatively treated intraductal carcinoma in situ, curatively treated cervical carcinoma in situ or curatively treated basal cell or squamous cell carcinoma;
  • Acute or active chronic infections;
  • Hepatitis C virus, hepatitis B virus, HIV, or syphilis infections;
  • Obstacles in intravenous administration of study drugs

Trial locations and contacts

44 sites in 4 countries.

44 sites in 4 countries

Russia27 sites

  • Arkhangelsk District Clinical Oncology Dispensary

    Arkhangelsk, 163045

  • Non-governmental Healthcare Institution "Railway Clinical hospital on the Chelyabinsk Station of JSC Russian Railways"

    Chelyabinsk, 454000

  • State-financed Health Institution "Chelyabinsk Region Clinical Oncology Dispansary"

    Chelyabinsk

  • State Healthcare Facility "Kursk Regional Oncology Dispensary"

    Kursk, 305035

  • Institution of Russian Academy of Medical Sciences "Russian Cancer Research Center named after N.N. Blokhin"

    Moscow, 115478

  • Federal State Institution "Moscow Institute of Cancer Research named after P.A. Hertsen" Ministry of Health of Russian Federation

    Moscow, 194044

  • State Health Institution of Moscow "Moscow City Oncology Hospital #62 of Moscow Board of Health"

    Moscow Region, 143423

  • Murmansk Regional Oncology Dispensary

    Murmansk, 183047

  • Nizhny Novgorod Region State Budgetary Healthcare Facility "Clinical Diagnostics Center"

    Nizhny Novgorod, 603006

  • State Healthcare Facility "Nizhny Novgorod Regional Oncology Dispensary"

    Nizhny Novgorod

  • City Clinical Hospital №1

    Novosibirsk, 630047

  • Regional State Health Institution "Orlov Oncology Dispansary"

    Oryol, 302020

  • State Health Institution "Region Oncology Dispansary"

    Penza, 440071

  • Perm Region Oncology Dispensary

    Perm, 614066

  • Federal Government Budgetary Institution "Rostov Institute of Cancer Research" of Ministry of Health of Russian Federation

    Rostov-on-Don, 314019

  • Saint Petersburg City Clinical Oncology Center

    Saint Petersburg, 197022

  • St. Petersburg State Medical University n.a. I. P. Pavlov

    Saint Petersburg, 197022

  • N.N.Petrov Oncology Research Center

    Saint Petersburg, 197758

  • St. Petersburg Research and Practice Center for Secondary Care in Oncology

    Saint Petersburg, 197758

  • Military Medical Academy named after S.M. Kirov

    Saint Petersburg

  • Russian scientific center of radiology and surgery technologies

    Saint Petersburg

  • State-financed Health Institution "Samara Region Clinical Oncology Dispansary"

    Samara, 443031

  • Oncology Dispensary 2

    Sochi, 354057

  • State-financed Health Institution "Stavropol Region Clinical Oncology Dispansary"

    Stavropol, 355047

  • Volgograd District Oncology Dispensary №1

    Volgograd, 400138

  • Volgograd Regional Oncology Dispensary №3

    Volgograd, 404130

  • State Health Institution "Voronezh Region Clinical Oncology Dispansary"

    Voronezh, 394000

Other trials in Russia

Ukraine10 sites

  • Donetsk City Oncology Dispensary

    Donetsk

  • Donetsk Regional Antitumor Center

    Donetsk

  • Kharkiv Regional Clinical Oncology Center

    Kharkiv

  • Kryvyi Rih Oncology Dispensary

    Kryvyi Rih

  • Lviv State Regional Cancer Diagnostic and Treatment Center

    Lviv

  • City Hospital № 2

    Makiivka

  • Poltava Regional Clinical Oncology Dispensary

    Poltava

  • Zakarpatskyi Clinical Oncology Dispensary

    Uzhhorod

  • Vinnytsia Regional Clinical Oncology Dispensary

    Vinnytsia

  • Zaporizhia Regional Clinical Oncology Dispensary

    Zaporizhia

Other trials in Ukraine

Belarus4 sites

  • Brest Regional Clinical Dispensary

    Brest

  • Grodno Regional Clinical Hospital

    Grodno

  • Gomel Regional Clinical Oncology Dispensary

    Homyel

  • Vitebsk Regional Clinical Oncology Dispensary

    Vitebsk

Other trials in Belarus

India3 sites

  • HCG Bangalore Institute of Oncology

    Bangalore, 560027

  • M.S.Ramaiah Memorial Hospital

    Bangalore, 560054

  • Narayana Hrudayalaya Hospitals

    Bangalore, 560099

Other trials in India

About this study

Official title: International Multicenter Randomized Double Blind Phase III Trial Comparing Safety and Efficacy of BCD-021 (CJSC BIOCAD, Russia) and Paclitaxel + Carboplatin to Avastin® (F. Hoffmann-La Roche Ltd, Switzerland) and Paclitaxel + Carboplatin in Inoperable or Advanced Non-squamous Non-small-cell Lung Cancer (NSCLC) Patients

BCD-021-02 is a double-blind randomized clinical trial comparing efficacy of BCD-021 (INN: bevacizumab) and paclitaxel + carboplatin to Avastin and paclitaxel + carboplatin in inoperable or advanced non-squamous NSCLC patients with pharmacokinetics substudy. The purpose of the study is to demonstrate the non-inferiority of efficacy and safety of BCD-021 compared to Avastin. Also study includes pharmacokinetics assessment.

Keywords
NSCLC, bevacizumab, pharmacokinetics
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.

  • BevacizumabDrug

    Also called Avastin, BCD-021

    Patients will receive 6 courses of bevacizumab in combination with carboplatin and paclitaxel. Bevacizumab will be administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each cycle).

  • PaclitaxelDrug

    Also called Taxacad

    Paclitaxel will be administered at a dose of 175 mg/m2 as 3 hour intravenous infusion on Day 1 of each 3-week course (6 courses totally)

  • CarboplatinDrug

    Carboplatin will be administered (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel on Day 1 of each 3-week course (6 courses totally).

Study groups in NCT01763645
Study groupRoleWhat they receive
BCD-021 (CISC BIOCAD)ExperimentalBCD-021 is a product code for bevacizumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 will be administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel will be administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
Receives: Drug: Bevacizumab; Drug: Paclitaxel; Drug: Carboplatin
Avastin (F. Hoffmann-La Roche Ltd)Active comparatorIn this arm patients will receive 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel. Avastin will be administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1. Paclitaxel will be administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
Receives: Drug: 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

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    Measured: Day 127

  2. Area Under the Curve After the First Test Drug Administration

    primary outcome measure for pharmacokinetics (PK) substudy

    Measured: up to Day 22, after the first bevacizumab administration (time points for blood samples: 0 h 1.5 h, 3 h, 4.5 h, 6 h, 24 h, 96 h, 168 h, 336 h and 504 h)

Secondary outcomes (5)

  1. Complete Response Rate

    secondary outcome measure for efficacy evaluation

    Measured: Day 127

  2. Partial Response Rate

    secondary outcome measure for efficacy evaluation

    Measured: Day 127

  3. Stabilization Rate

    secondary outcome measure for efficacy evaluation

    Measured: Day 127

  4. Progression Rate

    secondary outcome measure for efficacy evaluation

    Measured: Day 127

  5. Occurrence of Anti-bevacizumab Antibodies

    Secondary outcome measure for immunogenicity assessment

    Measured: Day 1 (before the drug administration), Day 15, 64 and 127

Timeline

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

  1. First posted9 Jan 2013 (estimated)
  2. Study startOct 2012
  3. Primary completionNov 2014
  4. Study completionNov 2014

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
Double blind
Who is masked
Participant, Investigator
Enrolment
353 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01763645
Sponsor's protocol ID
BCD-021-02
Status last verified
Apr 2023
First submitted
27 Dec 2012
Last updated
11 Jan 2024
Data monitoring committee
No

Publications

  • Stroyakovskiy DL, Fadeeva NV, Matrosova MP, Shelepen KG, Adamchuk GA, Roy B, Nagarkar R, Kalloli M, Zhuravleva D, Voevodin GD, Shustova MS, Kryukov F. Randomized double-blind clinical trial comparing safety and efficacy of the biosimilar BCD-021 with reference bevacizumab. BMC Cancer. 2022 Feb 1;22(1):129. doi: 10.1186/s12885-022-09243-7.

    PubMed 35105329

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bevacizumab, Paclitaxel and Carboplatin in people with Non-small Cell Lung Cancer, run by Biocad at 44 sites in 4 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 9 inclusion and 26 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 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in Russia, Ukraine, Belarus, India. 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 24 Oct 2016). 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 (time frame: Day 127). The study lists 2 primary outcomes in all. 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 NCT01763645, 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 11 Jan 2024.

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