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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 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2020-10-29

No results posted yet for this study

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

DRUG

BCD-100

monoclonal antibody to PD-1 receptor

DRUG

Docetaxel

Chemotherapy drug (taxane)

Sponsors & Collaborators

  • Biocad

    lead INDUSTRY

Principal Investigators

  • Roman A Ivanov, PhD · Vice President R&D, JSC BIOCAD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Belarus
  • Russia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03288870 on ClinicalTrials.gov