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

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 Overview

• Status: Unknown
• Conditions: Non Small Cell Lung Cancer Stage IIIB; Non-Small Cell Carcinoma of Lung, TNM Stage 4
• Intervention / Treatment: Drug: BCD-100; Drug: Docetaxel

• Study Type: Interventional
• Enrollment (Anticipated): 218
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Belarus
  • Gomel, Belarus
    • Gomel Regional Clinical Oncology Dispensary
• Russian Federation
  • Arkhangelsk, Russian Federation, 163045
    • Arkhangelsk District Clinical Oncology Dispensary
  • Krasnodar, Russian Federation, 350040
    • Clinical Oncology Dispensary N1
  • Moscow, Russian Federation, 105229
    • N.N. Burdenko General Military Clinical Hospital
  • Pyatigorsk, Russian Federation, 357502
    • Pyatigorsk Oncology Center
  • Saint Petersburg, Russian Federation, 197022
    • Saint Petersburg City Clinical Oncology Center
  • St.Petersburg, Russian Federation, 197758
    • N.N.Petrov Oncology Research Center
  • Ufa, Russian Federation, 450054
    • Republican Clinical Oncology Dispensary of Ministry of Health republic Bashkortostan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Verified diagnosis of non-small cell lung cancer
• Verified progression of the disease after or during first-line chemotherapy based on platinum drugs
• Absence of mutation of EGFR and ALK genes
• ECOG score 0-1
• At least one lesion, that is measurable according to RECIST 1.1 criteria
• Absence of severe organ pathology
• Anticipated live duration more that 12 weeks after screening
• Brain metastases with clinical symptoms requiring glucocorticoids and/or anticonvulsant drugs

Exclusion Criteria:

• EGFR and/or ALK mutations
• Patients with severe of live-threatening acute complications of the disease
• Intersticial lung diseases or pneumonitis
• Concomitant diseases that affect safety evaluation
• Autoimmune diseases
• Endocrine diseases that could not be compensated by hormonal therapy
• Patient needs glucocorticoids
• Significant liver or renal diseases
• Lactate dehydrogenase exceeds upper limit of normal more that 2-fold
• More that 1 chemotherapy lines for advanced/metastatic non-small cell lung cancer treatment
• Anti-tumor treatment ending less then 28 days before screening
• Prior therapy with anti-CTLA4 and/or anti-PD-1/PD-L1/PD-L2 drugs
• Prior therapy with docetaxel
• Concomitant oncological diseases except treated cervical carcinoma in situ or radically resected squamous-cell carcinoma
• Allergy to drugs based on monoclonal antibodies or docetaxel or polysorbate 80, severe reactions to paclitaxel
• Pregnancy and lactation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BCD-100 monotherapy; Patients will receive solution of BCD-100 in a dose 3 mg/kg every 3 weeks as intravenous infusion until progression of the disease or signs of intolerable toxicity	Drug: BCD-100; monoclonal antibody to PD-1 receptor
Active Comparator: Docetaxel monotherapy; Patients will receive solution of docetaxel in a dose 75 mg per square meter every 3 weeks as intravenous infusion until progression of the disease or signs of intolerable toxicity, maximum 6 cycles	Drug: Docetaxel; Chemotherapy drug (taxane)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Percent of patients who are alive after 1 year of therapy	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall response rate	Percent of patients who have complete or partial response to therapy	1 year
Progression-free survival	Percent of patients who are alive after 1 year of therapy	1 year

Collaborators and Investigators

• Sponsor: Biocad
• Investigators: Study Director: Roman A Ivanov, PhD, Vice President R&D, JSC BIOCAD

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2017
• Primary Completion (Actual): August 10, 2020
• Study Completion (Anticipated): August 10, 2021

Study Registration Dates

• First Submitted: August 23, 2017
• First Submitted That Met QC Criteria: September 19, 2017
• First Posted (Actual): September 20, 2017

Study Record Updates

• Last Update Posted (Actual): October 29, 2020
• Last Update Submitted That Met QC Criteria: October 28, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel
• Other Study ID Numbers: BCD-100-2/DOMINUS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No