Phase
Condition
N/ATreatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject has voluntarily agreed to participate by giving written informed consent forthe 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 metastaticdisease 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 (absoluteneutrophil count ≥1.500/mcL, platelets ≥100.000/mcL, hemoglobin ≥9 g/dL ), renallaboratory values (serum creatinine or calculated creatinine clearance <1.5xULN or ≥60mL/min for subjects with creatinine levels>1.5x institutional ULN), and hepaticlaboratory values (serum total bilirubin <1.5xULN, AST and ALT ≤2.5xULN, alkalinephosphatase <2.5xULN);
Agreement to newly obtained core or excisional biopsy of a tumor lesion not previouslyirradiated for determination of PD-L1 status prior to randomization (if obtaining ofnew sample is contraindicated or puts subject at unacceptable risks, then archivaltumor tissue sample must be available)
Measurable disease according to CT scan (RECIST 1.1 criteria) , confirmed by the localassessment;
For subjects of childbearing potential: agreement to remain abstinent (refrain fromheterosexual 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 ofthe last dose of study drug; and 6 months after the last dose of platinum-basedchemotherapy, whichever is later. A woman is considered to be of childbearingpotential if she is postmenarcheal, has not reached a postmenopausal state (≥ 12continuous months of amenorrhea with no identified cause other than menopause), andhas not undergone surgical sterilization (removal of ovaries, fallopian tubes, and/oruterus). Examples of contraceptive methods with a failure rate of < 1% per yearinclude but are not limited to bilateral tubal ligation and/or occlusion, malesterilization, and intrauterine devices. The reliability of sexual abstinence shouldbe evaluated in relation to the duration of the clinical study and the preferred andusual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation,symptothermal, or postovulation methods) and withdrawal are not acceptable methods ofcontraception.
Exclusion
Exclusion Criteria:
Has predominantly squamous cell histology NSCLC; Mixed tumors will be categorized bythe predominant cell type; if small cell elements are present, the subject isineligible.
Presence of EGFR mutation or ALK translocation;
Has received prior systemic cytotoxic chemotherapy/chemoradiotherapy for metastaticdisease;
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 torequire 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 drugadministration;
Current treatment in another investigational device or drug study, or less than 28days 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 maincondition (including but not limited to massive pleural, pericardial, or peritonealeffusion 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 studytreatment:
uncontrolled hypertension, defined as systolic > 150 mm Hg or diastolic > 90 mmHg; define diagnosis of hypertension
stable angina functional class III-IV;
unstable angina or myocardial infarction less than 6 months prior torandomization;
NYHA Grade III-IV congestive heart failure;
serious cardiac arrhythmia requiring medication (subjects with asymptomaticatrial 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 studytreatment in Investigator's opinion;
Has known active central nervous system (CNS) metastases and/or carcinomatousmeningitis ;
Active or known or suspected autoimmune disease (subjects with Type 1 diabetesmellitus, hypothyroidism only requiring hormone replacement, or skin disorders (vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted toenroll).
Has clinically active diverticulitis, intra-abdominal abscess, GI obstruction,abdominal carcinomatosis;
Has interstitial lung disease or a history of pneumonitis that required oral orintravenous glucocorticoids to assist with management. Lymphangitic spread of theNSCLC is not exclusionary;
Condition requiring systemic treatment with either corticosteroids or otherimmunosuppressive 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 potentiallycurative therapy with no evidence of that disease recurrence for 2 years sinceinitiation of that therapy, except for successful definitive resection of basal cellcarcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of theskin, in situ cervical cancer, or other in situ cancers;
Pre-existing clinically significant (≥ grade 2) peripheral neuropathy or hearingimpairment;
Any conditions or circumstances that limit subject's ability to comply with protocolrequirements;
Active hepatitis B, hepatitis С or HIV in anamnesis;
Acute infection or reactivation of chronic infection or systemic antibiotics use lessthan 14 days prior to first dose of the study drug; Severe infections within 28 daysprior to the first study drug administration.
Significant adverse reactions of previous therapy excluding chronic and/orirreversible events which cannot affect study drug safety evaluation (e.g. alopecia);
Known hypersensitivity or allergy to drugs containing Chinese hamster (CHO) ovarycells or history of severe allergic, anaphylactic, or other hypersensitivity reactionsto 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 theprojected duration of the study.
Study Design
Connect with a study center
Regional Hospital Liberec
Liberec,
CzechiaActive - Recruiting
University Hospital Olomouc
Olomouc,
CzechiaActive - Recruiting
University Hospital Ostrava
Ostrava,
CzechiaActive - Recruiting
Multiscan Pardubice - Radiology Center
Pardubice,
CzechiaActive - Recruiting
High technology Hospital Medcenter
Batumi,
GeorgiaActive - Recruiting
Acad. F.Todua Medical center "Research institute of Clinical Medicine"
Tbilisi,
GeorgiaActive - Recruiting
High Technology Medical Centre, University Clinic
Tbilisi,
GeorgiaActive - Recruiting
Institute for Personalized Medicine Ltd.
Tbilisi,
GeorgiaActive - Recruiting
LEPL First University Clinic of Tbilisi State Medical University
Tbilisi,
GeorgiaActive - Recruiting
National Korányi Institute of Pulmonology IV. Pulmonology
Budapest,
HungaryActive - Recruiting
Semmelweis University Pulmonology Clinic
Budapest,
HungaryActive - Recruiting
Mátra Health Institution Pulmonology
Mátraháza,
HungaryActive - Recruiting
S.C Radiotherapy Center Cluj S.R.L
Cluj,
RomaniaActive - Recruiting
S.C Medisprof S.R.L
Cluj-Napoca,
RomaniaActive - Recruiting
"Sfantul Nectarie" Oncology Center SRL
Craiova,
RomaniaActive - Recruiting
S.C Oncolab S.R.L
Craiova,
RomaniaActive - Recruiting
S.C Pelican Impex S.R.L
Oradea,
RomaniaActive - Recruiting
Emergency Clinical Municipal Hospital Timisoara - Medical Oncology Clinic
Timisoara,
RomaniaActive - Recruiting
S.C Oncocenter Clinical Oncology S.R.L
Timisoara,
RomaniaActive - Recruiting
S.C Oncomed S.R.L
Timisoara,
RomaniaActive - Recruiting
S.C Salvosan Ciobanca S.R.
Zalau,
RomaniaActive - Recruiting
Arkhangelsk Clinical Oncology Dispensary
Arkhangel'sk,
Russian FederationActive - Recruiting
City Hospital No. 5
Barnaul,
Russian FederationActive - Recruiting
Krasnoyarsk Regional Clinical Oncological Dispensary named after A.I. Kryzhanovsky
Krasnoyarsk,
Russian FederationActive - Recruiting
Moscow City Oncology Hospital No. 62
Moscow,
Russian FederationActive - Recruiting
Clinical Oncology Dispensary
Omsk,
Russian FederationActive - Recruiting
LLC "New Clinic"
Pyatigorsk,
Russian FederationActive - Recruiting
AV Medical Group
Saint Petersburg,
Russian FederationActive - Recruiting
LLC BioEk
Saint Petersburg,
Russian FederationActive - Recruiting
Regional Clinical Oncology Hospital
Yaroslavl,
Russian FederationActive - Recruiting
St. Jacob's Hospital
Bardejov,
SlovakiaActive - Recruiting
Hospital Komarno a.s.
Komarno,
SlovakiaActive - Recruiting
Eastern Slovak Oncology Institute
Košice,
SlovakiaActive - Recruiting
Faculty Hospital with Policlinic of Stefan Kukura
Michalovce,
SlovakiaActive - Recruiting
Faculty Hospital with Policlinic
Nove Zamky,
SlovakiaActive - Recruiting
Outpatient Oncology Clinic
Partizanske,
SlovakiaActive - Recruiting
Faculty Hospital of J.A. Reiman
Presov,
SlovakiaActive - Recruiting
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