Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
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)
Study ID: NCT03912389
Study Description
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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, , 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, Timisoara, , Romania
S.C Oncocenter Clinical Oncology S.R.L, Timisoara, , Romania
S.C Oncomed S.R.L, Timisoara, , Romania
S.C Salvosan Ciobanca S.R., Zalau, , Romania
Arkhangelsk Clinical Oncology Dispensary, Arkhangel'sk, , Russian Federation
City Hospital No. 5, Barnaul, , Russian Federation
Krasnoyarsk Regional Clinical Oncological Dispensary named after A.I. Kryzhanovsky, Krasnoyarsk, , Russian Federation
Moscow City Oncology Hospital No. 62, Moscow, , Russian Federation
Clinical Oncology Dispensary, Omsk, , Russian Federation
LLC "New Clinic", Pyatigorsk, , Russian Federation
AV Medical Group, Saint Petersburg, , Russian Federation
LLC BioEk, Saint Petersburg, , Russian Federation
Regional Clinical Oncology Hospital, Yaroslavl, , Russian Federation
St. Jacob's Hospital, Bardejov, , Slovakia
Hospital Komarno a.s., Komarno, , Slovakia
Eastern Slovak Oncology Institute, Košice, , Slovakia
Faculty Hospital with Policlinic of Stefan Kukura, Michalovce, , Slovakia
Faculty Hospital with Policlinic, Nove Zamky, , Slovakia
Outpatient Oncology Clinic, Partizanske, , Slovakia
Faculty Hospital of J.A. Reiman, Presov, , Slovakia
Contact Details
Name: Yulia N Linkova, MD, PhD
Affiliation: Director of Clinical Development Department, BIOCAD
Role: STUDY_DIRECTOR
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