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

NCT03912389 | Unknown Phase 3 DMC

• 1 other identifier: BCD-100-3
• Study Type: interventional
• Target: 292
• Locations: 6 countries
• Sites: 37

Brief 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. The main hypothesis of the study is that BCD-100 in combination with chemotherapy prolongs OS compared to placebo with chemotherapy.

Conditions

Non-Squamous Non-Small Cell Neoplasm of Lung

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  The time from the date of randomization until death

  3 years

Secondary Outcomes (5)

• Progression-Free Survival (PFS)

  1 year

• Overall Response Rate (ORR)

  1 year

• Disease Control Rate (DCR)

  1 year

• Time to Response (TTR)

  1 year

• Duration of Response (DOR)

  1 year

Study Arms (2)

BCD-100

EXPERIMENTAL

BCD-100 3 mg/kg Q3W

Biological: BCD-100; Drug: Pemetrexed; Drug: Cisplatin (or carboplatin)

Placebo

PLACEBO COMPARATOR

Drug: Pemetrexed; Drug: Cisplatin (or carboplatin); Other: Placebo

Interventions

BCD-100 BIOLOGICAL

Anti-PD-1 monoclonal antibody, IV infusion

BCD-100

Pemetrexed DRUG

IV infusion

BCD-100; Placebo

Cisplatin (or carboplatin) DRUG

IV infusion

BCD-100; Placebo

Placebo OTHER

IV infusion

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;
• 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);

Sponsors & Collaborators

• Biocad: lead

Study Sites (37)

Regional Hospital Liberec

Liberec, Czechia

RECRUITING

University Hospital Olomouc

Olomouc, Czechia

RECRUITING

University Hospital Ostrava

Ostrava, Czechia

RECRUITING

Multiscan Pardubice - Radiology Center

Pardubice, Czechia

RECRUITING

High technology Hospital Medcenter

Batumi, Georgia

RECRUITING

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

Tbilisi, Georgia

RECRUITING

High Technology Medical Centre, University Clinic

Tbilisi, Georgia

RECRUITING

Institute for Personalized Medicine Ltd.

Tbilisi, Georgia

RECRUITING

LEPL First University Clinic of Tbilisi State Medical University

Tbilisi, Georgia

RECRUITING

National Korányi Institute of Pulmonology IV. Pulmonology

Budapest, Hungary

RECRUITING

Semmelweis University Pulmonology Clinic

Budapest, Hungary

RECRUITING

Mátra Health Institution Pulmonology

Mátraháza, Hungary

RECRUITING

S.C Medisprof S.R.L

Cluj-Napoca, Romania

RECRUITING

S.C Radiotherapy Center Cluj S.R.L

Cluj-Napoca, Romania

RECRUITING

"Sfantul Nectarie" Oncology Center SRL

Craiova, Romania

RECRUITING

S.C Oncolab S.R.L

Craiova, Romania

RECRUITING

S.C Pelican Impex S.R.L

Oradea, Romania

RECRUITING

Emergency Clinical Municipal Hospital Timisoara - Medical Oncology Clinic

Timișoara, Romania

RECRUITING

S.C Oncocenter Clinical Oncology S.R.L

Timișoara, Romania

RECRUITING

S.C Oncomed S.R.L

Timișoara, Romania

RECRUITING

S.C Salvosan Ciobanca S.R.

Zalău, Romania

RECRUITING

Arkhangelsk Clinical Oncology Dispensary

Arkhangelsk, Russia

RECRUITING

City Hospital No. 5

Barnaul, Russia

RECRUITING

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

Krasnoyarsk, Russia

RECRUITING

Moscow City Oncology Hospital No. 62

Moscow, Russia

RECRUITING

Clinical Oncology Dispensary

Omsk, Russia

RECRUITING

LLC "New Clinic"

Pyatigorsk, Russia

RECRUITING

AV Medical Group

Saint Petersburg, Russia

RECRUITING

LLC BioEk

Saint Petersburg, Russia

RECRUITING

Regional Clinical Oncology Hospital

Yaroslavl, Russia

RECRUITING

St. Jacob's Hospital

Bardejov, Slovakia

RECRUITING

Hospital Komarno a.s.

Komárno, Slovakia

RECRUITING

Eastern Slovak Oncology Institute

Košice, Slovakia

RECRUITING

Faculty Hospital with Policlinic of Stefan Kukura

Michalovce, Slovakia

RECRUITING

Faculty Hospital with Policlinic

Nové Zámky, Slovakia

RECRUITING

Outpatient Oncology Clinic

Partizánske, Slovakia

RECRUITING

Faculty Hospital of J.A. Reiman

Prešov, Slovakia

RECRUITING

Related Publications (1)

• 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.

  PMID: 39879779 DERIVED

MeSH Terms

Interventions

Pemetrexed; Cisplatin; Carboplatin

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals

Study Officials

• Yulia N Linkova, MD, PhD

  Director of Clinical Development Department, BIOCAD

  STUDY DIRECTOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: April 11, 2019
• Study Start: June 1, 2019
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 17, 2020

Record last verified: 2020-09

Locations

HU (3); CZ (4); RU (9); SL (7); RO (9); GE (5)