drugset / Trial / NCT03288870

Efficacy, Safety and Pharmacokinetics of BCD-100 (Anti-PD-1) Monotherapy as Second Line Treatment in Patients With Non-Small Cell Lung Cancer (DOMINUS)

NCT03288870

Phase 2/3 Unknown 218 enrolled Biocad
RandomizedParallel-groupQuadruple-blindTreatment

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

Timeline

Start
2017-09-19
Primary completion
2020-08-10
Completion
2021-08-10

Drugs

EvaluationDrugModalityDoseRoute
Subject BCD-100 Monoclonal antibody 3 mg/kg Intravenous
Comparator Docetaxel Small molecule 75 mg/m2 Intravenous