Efficacy, Safety and Pharmacokinetics of BCD-100 (Anti-PD-1) Monotherapy as Second Line Treatment in Patients With Non-Small Cell Lung Cancer (DOMINUS)
NCT ID: NCT03288870
Last Updated: 2020-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
218 participants
INTERVENTIONAL
2017-09-19
2021-08-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
BCD-100
monoclonal antibody to PD-1 receptor
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
Docetaxel
Chemotherapy drug (taxane)
Interventions
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BCD-100
monoclonal antibody to PD-1 receptor
Docetaxel
Chemotherapy drug (taxane)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Biocad
INDUSTRY
Responsible Party
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Principal Investigators
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Roman A Ivanov, PhD
Role: STUDY_DIRECTOR
Vice President R&D, JSC BIOCAD
Locations
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Gomel Regional Clinical Oncology Dispensary
Homyel, , Belarus
Arkhangelsk District Clinical Oncology Dispensary
Arkhangelsk, , Russia
Clinical Oncology Dispensary N1
Krasnodar, , Russia
N.N. Burdenko General Military Clinical Hospital
Moscow, , Russia
Pyatigorsk Oncology Center
Pyatigorsk, , Russia
Saint Petersburg City Clinical Oncology Center
Saint Petersburg, , Russia
N.N.Petrov Oncology Research Center
Saint Petersburg, , Russia
Republican Clinical Oncology Dispensary of Ministry of Health republic Bashkortostan
Ufa, , Russia
Countries
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Other Identifiers
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BCD-100-2/DOMINUS
Identifier Type: -
Identifier Source: org_study_id