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Brief Title: Efficacy, Safety and Pharmacokinetics of BCD-100 (Anti-PD-1) Monotherapy as Second Line Treatment in Patients With Non-Small Cell Lung Cancer (DOMINUS)
Official Title: International Multi-center Open-label Randomized Clinical Trial of Efficacy, Safety and Pharmacokinetics of BCD-100 (JSC "BIOCAD", Russia) Monotherapy Compared to Docetaxel as Second-line Therapy of Patients With Advanced Inoperable or Metastatic Non-small Cell Lung Cancer
Study ID: NCT03288870
Brief Summary: International multi-center open-label randomized clinical trial of efficacy, safety and pharmacokinetics of BCD-100 (JSC BIOCAD, Russia) monotherapy compared to docetaxel as second-line therapy of patients with advanced inoperable or metastatic non-small cell lung cancer
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Gomel Regional Clinical Oncology Dispensary, Gomel, , Belarus
Arkhangelsk District Clinical Oncology Dispensary, Arkhangelsk, , Russian Federation
Clinical Oncology Dispensary N1, Krasnodar, , Russian Federation
N.N. Burdenko General Military Clinical Hospital, Moscow, , Russian Federation
Pyatigorsk Oncology Center, Pyatigorsk, , Russian Federation
Saint Petersburg City Clinical Oncology Center, Saint Petersburg, , Russian Federation
N.N.Petrov Oncology Research Center, St.Petersburg, , Russian Federation
Republican Clinical Oncology Dispensary of Ministry of Health republic Bashkortostan, Ufa, , Russian Federation
Name: Roman A Ivanov, PhD
Affiliation: Vice President R&D, JSC BIOCAD
Role: STUDY_DIRECTOR