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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03288870
Recruitment Status : Active, not recruiting
First Posted : September 20, 2017
Last Update Posted : October 29, 2020
Sponsor:
Information provided by (Responsible Party):
Biocad

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

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Stage IIIB Non-Small Cell Carcinoma of Lung, TNM Stage 4 Drug: BCD-100 Drug: Docetaxel Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 218 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 19, 2017
Actual Primary Completion Date : August 10, 2020
Estimated Study Completion Date : August 10, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel

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)




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 1 year ]
    Percent of patients who are alive after 1 year of therapy


Secondary Outcome Measures :
  1. Overall response rate [ Time Frame: 1 year ]
    Percent of patients who have complete or partial response to therapy

  2. Progression-free survival [ Time Frame: 1 year ]
    Percent of patients who are alive after 1 year of therapy



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03288870


Locations
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Belarus
Gomel Regional Clinical Oncology Dispensary
Gomel, Belarus
Russian Federation
Arkhangelsk District Clinical Oncology Dispensary
Arkhangelsk, Russian Federation, 163045
Clinical Oncology Dispensary N1
Krasnodar, Russian Federation, 350040
N.N. Burdenko General Military Clinical Hospital
Moscow, Russian Federation, 105229
Pyatigorsk Oncology Center
Pyatigorsk, Russian Federation, 357502
Saint Petersburg City Clinical Oncology Center
Saint Petersburg, Russian Federation, 197022
N.N.Petrov Oncology Research Center
St.Petersburg, Russian Federation, 197758
Republican Clinical Oncology Dispensary of Ministry of Health republic Bashkortostan
Ufa, Russian Federation, 450054
Sponsors and Collaborators
Biocad
Investigators
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Study Director: Roman A Ivanov, PhD Vice President R&D, JSC BIOCAD
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Responsible Party: Biocad
ClinicalTrials.gov Identifier: NCT03288870    
Other Study ID Numbers: BCD-100-2/DOMINUS
First Posted: September 20, 2017    Key Record Dates
Last Update Posted: October 29, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action