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)

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 218 (estimated)
• Sponsor: Biocad · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Non Small Cell Lung Cancer Stage IIIB
• Non-Small Cell Carcinoma of Lung, TNM Stage 4

Interventions

Type	Name	Description
DRUG	BCD-100	monoclonal antibody to PD-1 receptor
DRUG	Docetaxel	Chemotherapy drug (taxane)

Timeline

• Start date: 2017-09-19
• Primary completion: 2020-08-10
• Completion: 2021-08-10
• First posted: 2017-09-20
• Last updated: 2020-10-29

Locations

8 sites across 2 countries: Belarus, Russia