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
NCT ID: NCT03912389
Last Updated: 2020-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
292 participants
INTERVENTIONAL
2019-06-01
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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BCD-100
BCD-100 3 mg/kg Q3W
BCD-100
Anti-PD-1 monoclonal antibody, IV infusion
Pemetrexed
IV infusion
Cisplatin (or carboplatin)
IV infusion
Placebo
Pemetrexed
IV infusion
Cisplatin (or carboplatin)
IV infusion
Placebo
IV infusion
Interventions
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BCD-100
Anti-PD-1 monoclonal antibody, IV infusion
Pemetrexed
IV infusion
Cisplatin (or carboplatin)
IV infusion
Placebo
IV infusion
Eligibility Criteria
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Inclusion Criteria
2. Patients ≥ 18 years of age on day of signing informed consent;
3. Previously untreated patients with histologically-confirmed stage IV (M1a/M1b/M1c- AJCC 8th edition) non-squamous NSCLC;
4. Has not received prior systemic treatment for metastatic NSCLC;
5. The time from the completion of previous adjuvant/neoadjuvant treatment to metastatic disease development is no less than 12 months;
6. Has a life expectancy of at least 12 weeks;
7. Has Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
8. 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);
9. 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)
10. Measurable disease according to CT scan (RECIST 1.1 criteria) , confirmed by the local assessment;
11. 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.
Exclusion Criteria
2. Presence of EGFR mutation or ALK translocation;
3. Has received prior systemic cytotoxic chemotherapy/chemoradiotherapy for metastatic disease;
4. 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;
5. Completed radiation therapy within 14 days before the first dose of the study drug;
6. Received a live-virus vaccination within 30 days prior to the first study drug administration;
7. Current treatment in another investigational device or drug study, or less than 28 days since ending treatment on another investigational device or drug study;
8. Had major surgery less than 28 days prior to the first dose of the study drug;
9. 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;
10. Concomitant diseases or conditions which pose a risk of AE development during study treatment:
1. uncontrolled hypertension, defined as systolic \> 150 mm Hg or diastolic \> 90 mm Hg; define diagnosis of hypertension
2. stable angina functional class III-IV;
3. unstable angina or myocardial infarction less than 6 months prior to randomization;
4. NYHA Grade III-IV congestive heart failure;
5. serious cardiac arrhythmia requiring medication (subjects with asymptomatic atrial fibrillation can be enrolled if controlled ventricular rate);
6. atopic asthma, Stage III-IV COPD, angioedema;
7. severe respiratory failure;
8. any other diseases which pose unacceptable risk of AE development during study treatment in Investigator's opinion;
11. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis ;
12. 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).
13. Has clinically active diverticulitis, intra-abdominal abscess, GI obstruction, abdominal carcinomatosis;
14. 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;
15. Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications in past 2 years;
16. Is unable or unwilling to take folic acid or vitamin B12 supplementation;
17. 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;
18. Pre-existing clinically significant (≥ grade 2) peripheral neuropathy or hearing impairment;
19. Any conditions or circumstances that limit subject's ability to comply with protocol requirements;
20. Active hepatitis B, hepatitis С or HIV in anamnesis;
21. 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.
22. Significant adverse reactions of previous therapy excluding chronic and/or irreversible events which cannot affect study drug safety evaluation (e.g. alopecia);
23. 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;
24. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.
18 Years
ALL
No
Sponsors
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Biocad
INDUSTRY
Responsible Party
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Principal Investigators
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Yulia N Linkova, MD, PhD
Role: STUDY_DIRECTOR
Director of Clinical Development Department, BIOCAD
Locations
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Regional Hospital Liberec
Liberec, , Czechia
University Hospital Olomouc
Olomouc, , Czechia
University Hospital Ostrava
Ostrava, , Czechia
Multiscan Pardubice - Radiology Center
Pardubice, , Czechia
High technology Hospital Medcenter
Batumi, , Georgia
Acad. F.Todua Medical center "Research institute of Clinical Medicine"
Tbilisi, , Georgia
High Technology Medical Centre, University Clinic
Tbilisi, , Georgia
Institute for Personalized Medicine Ltd.
Tbilisi, , Georgia
LEPL First University Clinic of Tbilisi State Medical University
Tbilisi, , Georgia
National Korányi Institute of Pulmonology IV. Pulmonology
Budapest, , Hungary
Semmelweis University Pulmonology Clinic
Budapest, , Hungary
Mátra Health Institution Pulmonology
Mátraháza, , Hungary
S.C Medisprof S.R.L
Cluj-Napoca, , Romania
S.C Radiotherapy Center Cluj S.R.L
Cluj-Napoca, , Romania
"Sfantul Nectarie" Oncology Center SRL
Craiova, , Romania
S.C Oncolab S.R.L
Craiova, , Romania
S.C Pelican Impex S.R.L
Oradea, , Romania
Emergency Clinical Municipal Hospital Timisoara - Medical Oncology Clinic
Timișoara, , Romania
S.C Oncocenter Clinical Oncology S.R.L
Timișoara, , Romania
S.C Oncomed S.R.L
Timișoara, , Romania
S.C Salvosan Ciobanca S.R.
Zalău, , Romania
Arkhangelsk Clinical Oncology Dispensary
Arkhangelsk, , Russia
City Hospital No. 5
Barnaul, , Russia
Krasnoyarsk Regional Clinical Oncological Dispensary named after A.I. Kryzhanovsky
Krasnoyarsk, , Russia
Moscow City Oncology Hospital No. 62
Moscow, , Russia
Clinical Oncology Dispensary
Omsk, , Russia
LLC "New Clinic"
Pyatigorsk, , Russia
AV Medical Group
Saint Petersburg, , Russia
LLC BioEk
Saint Petersburg, , Russia
Regional Clinical Oncology Hospital
Yaroslavl, , Russia
St. Jacob's Hospital
Bardejov, , Slovakia
Hospital Komarno a.s.
Komárno, , Slovakia
Eastern Slovak Oncology Institute
Košice, , Slovakia
Faculty Hospital with Policlinic of Stefan Kukura
Michalovce, , Slovakia
Faculty Hospital with Policlinic
Nové Zámky, , Slovakia
Outpatient Oncology Clinic
Partizánske, , Slovakia
Faculty Hospital of J.A. Reiman
Prešov, , Slovakia
Countries
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Central Contacts
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Facility Contacts
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Marek Sochor, MD
Role: primary
Bohuslav Melichar, MD, PhD
Role: primary
Tomas Bartek, MD
Role: primary
Jaroslav Vanasek, MD, PhD
Role: primary
Tamta Makharadze, MD
Role: primary
Tamar Melkadze, MD
Role: primary
Miranda Gogishvili, MD
Role: primary
Alexandre Tavartkiladze, MD, PhD
Role: primary
Nana Chikhladze, MD
Role: primary
Krisztina BOGOS, MD
Role: primary
Veronika MÜLLER, MD, PhD
Role: primary
László URBÁN, MD, PhD
Role: primary
Udrea A Anghel, MD
Role: primary
Manolescu A Alexandru, MD
Role: primary
Schenker Michael, MD
Role: primary
Lungulescu Stefan, MD
Role: primary
Puscas I Adriana, MD
Role: primary
Curescu Petra, MD
Role: primary
Scheusan R Ioana, MD
Role: primary
Segarceanu N Alina, MD
Role: primary
Papp Margareta, MD
Role: primary
Marina N Nechaeva, MD
Role: primary
Denis A Tancyirev, MD
Role: primary
Ruslan A Zukov, MD, PhD
Role: primary
Daniil L Stroyakovsky, MD, PhD
Role: primary
Mikhail V Dvorkin, MD, PhD
Role: primary
Valery M Chistyakov, MD, PhD
Role: primary
Timur T Andabekov, MD, PhD
Role: primary
Svetlana Odintsova, MD
Role: primary
Nikolay V Kislov, MD, PhD
Role: primary
Jozef Chovanec, MD
Role: primary
Olga Rosinska, MD
Role: primary
Igor Andrasina, MD, PhD
Role: primary
Gabriela Hermanova, MD
Role: primary
Pavol Demo, MD
Role: primary
Alexandra Szabova, MD
Role: primary
Jaroslava Leskova, MD
Role: primary
References
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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.
Other Identifiers
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BCD-100-3
Identifier Type: -
Identifier Source: org_study_id
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