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Non-Squamous Non-Small Cell Neoplasm of LungPhase 3DOMAJORNCT03912389

Efficacy and Safety of BCD-100 (Anti-PD-1) in Combination With Platinum-Based Chemotherapy as First Line Treatment in Patients With Advanced Non-Squamous NSCLC

A Phase 3 study testing BCD-100, Pemetrexed and Cisplatin (or carboplatin) in people with Non-Squamous Non-Small Cell Neoplasm of Lung, run by Biocad at 37 sites in 6 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This is a randomized, multicenter, double-blind placebo-controlled phase 3 study of efficacy and safety of BCD-100 in combination with pemetrexed+cisplatin/carboplatin compared to placebo in combination with pemetrexed+cisplatin/carboplatin in subjects with previously untreated metastatic non-squamous NSCLC. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BCD-100, Pemetrexed and Cisplatin (or carboplatin)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
292 participants
Where
37 sitesin 6 countries
Study dates
1 Jun 2019to Dec 2023
Phase
Phase 3
Are there results?
None posted in the registry

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

  • Subject has voluntarily agreed to participate by giving written informed consent for the trial;
  • Patients ≥ 18 years of age on day of signing informed consent;
  • Previously untreated patients with histologically-confirmed stage IV (M1a/M1b/M1c- AJCC 8th edition) non-squamous NSCLC;
  • Has not received prior systemic treatment for metastatic NSCLC;
  • The time from the completion of previous adjuvant/neoadjuvant treatment to metastatic disease development is no less than 12 months;
  • Has a life expectancy of at least 12 weeks;
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  • Has Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
  • Has adequate organ function as defined by hematological laboratory values (absolute neutrophil count ≥1.500/mcL, platelets ≥100.000/mcL, hemoglobin ≥9 g/dL ), renal laboratory values (serum creatinine or calculated creatinine clearance <1.5xULN or ≥60 mL/min for subjects with creatinine levels>1.5x institutional ULN), and hepatic laboratory values (serum total bilirubin <1.5xULN, AST and ALT ≤2.5xULN, alkaline phosphatase <2.5xULN);
  • Agreement to newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for determination of PD-L1 status prior to randomization (if obtaining of new sample is contraindicated or puts subject at unacceptable risks, then archival tumor tissue sample must be available)
  • Measurable disease according to CT scan (RECIST 1.1 criteria) , confirmed by the local assessment;
  • For subjects of childbearing potential: agreement to remain abstinent (refrain from heterosexual inter-course) or use a contraceptive method with a failure rate of < 1% per year during the treatment period and for at least 6 months after administration of the last dose of study drug; and 6 months after the last dose of platinum-based chemotherapy, whichever is later. A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries, fallopian tubes, and/or uterus). Examples of contraceptive methods with a failure rate of < 1% per year include but are not limited to bilateral tubal ligation and/or occlusion, male sterilization, and intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.

Who cannot join

  • Has predominantly squamous cell histology NSCLC; Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the subject is ineligible.
  • Presence of EGFR mutation or ALK translocation;
  • Has received prior systemic cytotoxic chemotherapy/chemoradiotherapy for metastatic disease;
  • Has received antineoplastic therapy with targeted or immunotherapeutic drugs (including but not limited to EGFR inhibitors [e.g., erlotinib, gefitinib, cetuximab], ALK inhibitors, PD-1/PD-L1/PD-L2/CTLA4, VEGF/VEGFR inhibitors) or it is expected to require any other form of antineoplastic therapy while on study;
  • Completed radiation therapy within 14 days before the first dose of the study drug;
  • Received a live-virus vaccination within 30 days prior to the first study drug administration;
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  • Current treatment in another investigational device or drug study, or less than 28 days since ending treatment on another investigational device or drug study;
  • Had major surgery less than 28 days prior to the first dose of the study drug;
  • Evidence of severe or concomitant diseases/life-threatening complications of the main condition (including but not limited to massive pleural, pericardial, or peritoneal effusion that requires medical intervention , pulmonary lymphangitis, hemorrhage, organ perforation) at the signing of the informed consent;
  • Concomitant diseases or conditions which pose a risk of AE development during study treatment:
  • uncontrolled hypertension, defined as systolic > 150 mm Hg or diastolic > 90 mm Hg; define diagnosis of hypertension
  • stable angina functional class III-IV;
  • unstable angina or myocardial infarction less than 6 months prior to randomization;
  • NYHA Grade III-IV congestive heart failure;
  • serious cardiac arrhythmia requiring medication (subjects with asymptomatic atrial fibrillation can be enrolled if controlled ventricular rate);
  • atopic asthma, Stage III-IV COPD, angioedema;
  • severe respiratory failure;
  • any other diseases which pose unacceptable risk of AE development during study treatment in Investigator's opinion;
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis ;
  • Active or known or suspected autoimmune disease (subjects with Type 1 diabetes mellitus, hypothyroidism only requiring hormone replacement, or skin disorders (vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll).
  • Has clinically active diverticulitis, intra-abdominal abscess, GI obstruction, abdominal carcinomatosis;
  • Has interstitial lung disease or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management. Lymphangitic spread of the NSCLC is not exclusionary;
  • Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications in past 2 years;
  • Is unable or unwilling to take folic acid or vitamin B12 supplementation;
  • Known history of prior malignancy except if participant has undergone potentially curative therapy with no evidence of that disease recurrence for 2 years since initiation of that therapy, except for successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers;
  • Pre-existing clinically significant (≥ grade 2) peripheral neuropathy or hearing impairment;
  • Any conditions or circumstances that limit subject's ability to comply with protocol requirements;
  • Active hepatitis B, hepatitis С or HIV in anamnesis;
  • Acute infection or reactivation of chronic infection or systemic antibiotics use less than 14 days prior to first dose of the study drug; Severe infections within 28 days prior to the first study drug administration.
  • Significant adverse reactions of previous therapy excluding chronic and/or irreversible events which cannot affect study drug safety evaluation (e.g. alopecia);
  • Known hypersensitivity or allergy to drugs containing Chinese hamster (CHO) ovary cells or history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins, to pemetrexed, carboplatin, cisplatin, BCD-100 or any of their excipients;
  • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.

Trial locations and contacts

37 sites in 6 countries.

Fedor B Krykov, MD, PhD contact

+7-(812)-380-49-33

biocad@biocad.ru

Sergey N Fogt, MD, PhD contact

+7-(812)-380-49-33

biocad@biocad.ru

37 sites in 6 countries

Romania9 sites, 9 recruiting

  • S.C Medisprof S.R.L

    Cluj-Napoca

    Udrea A Anghel, MD

    Recruiting

  • S.C Radiotherapy Center Cluj S.R.L

    Cluj-Napoca

    Manolescu A Alexandru, MD

    Recruiting

  • "Sfantul Nectarie" Oncology Center SRL

    Craiova

    Schenker Michael, MD

    Recruiting

  • S.C Oncolab S.R.L

    Craiova

    Lungulescu Stefan, MD

    Recruiting

  • S.C Pelican Impex S.R.L

    Oradea

    Puscas I Adriana, MD

    Recruiting

  • Emergency Clinical Municipal Hospital Timisoara - Medical Oncology Clinic

    Timișoara

    Curescu Petra, MD

    Recruiting

  • S.C Oncocenter Clinical Oncology S.R.L

    Timișoara

    Scheusan R Ioana, MD

    Recruiting

  • S.C Oncomed S.R.L

    Timișoara

    Segarceanu N Alina, MD

    Recruiting

  • S.C Salvosan Ciobanca S.R.

    Zalău

    Papp Margareta, MD

    Recruiting

Other trials in Romania

Russia9 sites, 9 recruiting

  • Arkhangelsk Clinical Oncology Dispensary

    Arkhangelsk

    Marina N Nechaeva, MD

    Recruiting

  • City Hospital No. 5

    Barnaul

    Denis A Tancyirev, MD

    Recruiting

  • Krasnoyarsk Regional Clinical Oncological Dispensary named after A.I. Kryzhanovsky

    Krasnoyarsk

    Ruslan A Zukov, MD, PhD

    Recruiting

  • Moscow City Oncology Hospital No. 62

    Moscow

    Daniil L Stroyakovsky, MD, PhD

    Recruiting

  • Clinical Oncology Dispensary

    Omsk

    Mikhail V Dvorkin, MD, PhD

    Recruiting

  • LLC "New Clinic"

    Pyatigorsk

    Valery M Chistyakov, MD, PhD

    Recruiting

  • AV Medical Group

    Saint Petersburg

    Timur T Andabekov, MD, PhD

    Recruiting

  • LLC BioEk

    Saint Petersburg

    Svetlana Odintsova, MD, +78129452232

    Recruiting

  • Regional Clinical Oncology Hospital

    Yaroslavl

    Nikolay V Kislov, MD, PhD

    Recruiting

Other trials in Russia

Slovakia7 sites, 7 recruiting

  • St. Jacob's Hospital

    Bardejov

    Jozef Chovanec, MD

    Recruiting

  • Hospital Komarno a.s.

    Komárno

    Olga Rosinska, MD

    Recruiting

  • Eastern Slovak Oncology Institute

    Košice

    Igor Andrasina, MD, PhD

    Recruiting

  • Faculty Hospital with Policlinic of Stefan Kukura

    Michalovce

    Gabriela Hermanova, MD

    Recruiting

  • Faculty Hospital with Policlinic

    Nové Zámky

    Pavol Demo, MD

    Recruiting

  • Outpatient Oncology Clinic

    Partizánske

    Alexandra Szabova, MD

    Recruiting

  • Faculty Hospital of J.A. Reiman

    Prešov

    Jaroslava Leskova, MD

    Recruiting

Other trials in Slovakia

Georgia5 sites, 5 recruiting

  • High technology Hospital Medcenter

    Batumi

    Tamta Makharadze, MD

    Recruiting

  • Acad. F.Todua Medical center "Research institute of Clinical Medicine"

    Tbilisi

    Tamar Melkadze, MD

    Recruiting

  • High Technology Medical Centre, University Clinic

    Tbilisi

    Miranda Gogishvili, MD

    Recruiting

  • Institute for Personalized Medicine Ltd.

    Tbilisi

    Alexandre Tavartkiladze, MD, PhD

    Recruiting

  • LEPL First University Clinic of Tbilisi State Medical University

    Tbilisi

    Nana Chikhladze, MD

    Recruiting

Other trials in Georgia

Czechia4 sites, 4 recruiting

  • Regional Hospital Liberec

    Liberec

    Marek Sochor, MD

    Recruiting

  • University Hospital Olomouc

    Olomouc

    Bohuslav Melichar, MD, PhD

    Recruiting

  • University Hospital Ostrava

    Ostrava

    Tomas Bartek, MD

    Recruiting

  • Multiscan Pardubice - Radiology Center

    Pardubice

    Jaroslav Vanasek, MD, PhD

    Recruiting

Other trials in Czechia

Hungary3 sites, 3 recruiting

  • National Korányi Institute of Pulmonology IV. Pulmonology

    Budapest

    Krisztina BOGOS, MD

    Recruiting

  • Semmelweis University Pulmonology Clinic

    Budapest

    Veronika MÜLLER, MD, PhD

    Recruiting

  • Mátra Health Institution Pulmonology

    Mátraháza

    László URBÁN, MD, PhD

    Recruiting

Other trials in Hungary

About this study

Official title: International Multicenter Randomized Double-Blind Placebo-Controlled Clinical Trial Evaluating Efficacy and Safety Of BCD-100 in Combination With Pemetrexed+Cisplatin/Carboplatin Compared to Placebo in Combination With Pemetrexed+Cisplatin/Carboplatin as First-Line Treatment of Subjects With Advanced Non-squamous Non-Small Cell Lung Cancer (NSCLC)

This is a randomized, multicenter, double-blind placebo-controlled phase 3 study of efficacy and safety of BCD-100 in combination with pemetrexed+cisplatin/carboplatin compared to placebo in combination with pemetrexed+cisplatin/carboplatin in subjects with previously untreated metastatic non-squamous NSCLC. The main hypothesis of the study is that BCD-100 in combination with chemotherapy prolongs OS compared to placebo with chemotherapy.

Being tested
BCD-100, Pemetrexed, Cisplatin (or carboplatin), Placebo

What participants receive

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

  • BCD-100Biological

    Anti-PD-1 monoclonal antibody, IV infusion

  • PemetrexedDrug

    IV infusion

  • Cisplatin (or carboplatin)Drug

    IV infusion

  • PlaceboOther

    IV infusion

Study groups in NCT03912389
Study groupRoleWhat they receive
BCD-100ExperimentalBCD-100 3 mg/kg Q3W
Receives: Biological: BCD-100; Drug: Pemetrexed; Drug: Cisplatin (or carboplatin)
PlaceboPlacebo comparatorNot described
Receives: Drug: Pemetrexed; Drug: Cisplatin (or carboplatin); Other: Placebo

What is being measured

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

  1. Overall Survival (OS)

    The time from the date of randomization until death

    Measured: 3 years

Secondary outcomes (5)

  1. Progression-Free Survival (PFS)

    The time from the date of randomization until progression of disease according to RECIST 1.1 and iRECIST or death

    Measured: 1 year

  2. Overall Response Rate (ORR)

    The percentage of the participants who have a Complete Response or a Partial Response as assessed by a blind independent central reviewer per RECIST 1.1 and iRECIST

    Measured: 1 year

  3. Disease Control Rate (DCR)

    The percentage of the participants who have a Complete Response, a Partial Response or a Stable Disease as assessed by a blind independent central reviewer per RECIST 1.1 and iRECIST

    Measured: 1 year

  4. Time to Response (TTR)

    TTR will be calculated from the randomization date

    Measured: 1 year

  5. Duration of Response (DOR)

    DOR will be calculated from the moment of registration of response till event (disease progression or death)

    Measured: 1 year

Timeline

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

  1. First posted11 Apr 2019
  2. Study start1 Jun 2019
  3. Primary completionDec 2023 (estimated)
  4. Study completionDec 2023 (estimated)

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
292 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03912389
Sponsor's protocol ID
BCD-100-3
Acronym
DOMAJOR
Status last verified
Sep 2020
First submitted
10 Apr 2019
Last updated
17 Sep 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Laktionov K, Smolin A, Stroyakovskiy D, Moiseenko V, Dvorkin M, Andabekov T, Cheng Y, Liu B, Kozlov V, Odintsova S, Dvoretsky S, Mochalova A, Urda M, Yi T, Li X, Laszlo U, Muller V, Bogos K, Fadeeva N, Musaev G, Liu Q, Kirtbaya D, Shi J, Gladkov O, Narimanov M, Semiglazova T, Khasanova A, Chovanec J, Andrasina I, Szabova A, Rosinska O, Sudekova D, Zsolt PS, Ran F, Sun M, Jiang O, Chen R, Zhao E, Liu C, Tan W, Pirmagomedov A, Poddubskaya E, Kislov N, Shumskaya I, Sorokina I, Zinkina-Orikhan A, Linkova Y, Fogt S, Liaptseva D, Siliutina A, Basova O, Kryukov F. Prolgolimab with chemotherapy as first-line treatment for advanced non-squamous non-small-cell lung cancer. Eur J Cancer. 2025 Feb 25;217:115255. doi: 10.1016/j.ejca.2025.115255. Epub 2025 Jan 21.

    PubMed 39879779

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BCD-100, Pemetrexed and Cisplatin (or carboplatin) in people with Non-Squamous Non-Small Cell Neoplasm of Lung, run by Biocad at 37 sites in 6 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 11 inclusion and 32 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: status not confirmed, as of the sponsor's last update on 17 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in Romania, Russia, Slovakia, Georgia, Czechia and 1 more country. 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. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Fedor B Krykov, MD, PhD (+7-(812)-380-49-33, biocad@biocad.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: 3 years). 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 NCT03912389, 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 17 Sep 2020.

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