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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) (DOMINUS)

Primary Purpose

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

Status

Unknown status

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

BCD-100

Docetaxel

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer Stage IIIB

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Gomel Regional Clinical Oncology Dispensary
Arkhangelsk District Clinical Oncology Dispensary
Clinical Oncology Dispensary N1
N.N. Burdenko General Military Clinical Hospital
Pyatigorsk Oncology Center
Saint Petersburg City Clinical Oncology Center
N.N.Petrov Oncology Research Center
Republican Clinical Oncology Dispensary of Ministry of Health republic Bashkortostan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BCD-100 monotherapy

Docetaxel monotherapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

Overall survival

Percent of patients who are alive after 1 year of therapy

Secondary Outcome Measures

Overall response rate

Percent of patients who have complete or partial response to therapy

Progression-free survival

Percent of patients who are alive after 1 year of therapy

Full Information

NCT ID

NCT03288870

First Posted

August 23, 2017

Last Updated

October 28, 2020

Sponsor

Biocad

1. Study Identification

Unique Protocol Identification Number

NCT03288870

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)

Acronym

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 Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Unknown status

Study Start Date

September 19, 2017 (Actual)

Primary Completion Date

August 10, 2020 (Actual)

Study Completion Date

August 10, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biocad

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

218 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

BCD-100 monotherapy

Arm Type

Experimental

Arm Description

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

Arm Title

Docetaxel monotherapy

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

BCD-100

Intervention Description

monoclonal antibody to PD-1 receptor

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Intervention Description

Chemotherapy drug (taxane)

Primary Outcome Measure Information:

Title

Overall survival

Description

Percent of patients who are alive after 1 year of therapy

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Overall response rate

Description

Percent of patients who have complete or partial response to therapy

Time Frame

1 year

Title

Progression-free survival

Description

Percent of patients who are alive after 1 year of therapy

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Roman A Ivanov, PhD

Organizational Affiliation

Vice President R&D, JSC BIOCAD

Official's Role

Study Director

Facility Information:

Facility Name

Gomel Regional Clinical Oncology Dispensary

City

Gomel

Country

Belarus

Facility Name

Arkhangelsk District Clinical Oncology Dispensary

City

Arkhangelsk

ZIP/Postal Code

163045

Country

Russian Federation

Facility Name

Clinical Oncology Dispensary N1

City

Krasnodar

ZIP/Postal Code

350040

Country

Russian Federation

Facility Name

N.N. Burdenko General Military Clinical Hospital

City

Moscow

ZIP/Postal Code

105229

Country

Russian Federation

Facility Name

Pyatigorsk Oncology Center

City

Pyatigorsk

ZIP/Postal Code

357502

Country

Russian Federation

Facility Name

Saint Petersburg City Clinical Oncology Center

City

Saint Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

N.N.Petrov Oncology Research Center

City

St.Petersburg

ZIP/Postal Code

197758

Country

Russian Federation

Facility Name

Republican Clinical Oncology Dispensary of Ministry of Health republic Bashkortostan

City

Ufa

ZIP/Postal Code

450054

Country

Russian Federation

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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