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

Study Overview
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Brief Summary
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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

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

Intervention / Treatment
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* Drug: BCD-100
* Drug: Docetaxel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BCD-100 monotherapy<br>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<br>* monoclonal antibody to PD-1 receptor<br>|
| Active Comparator: Docetaxel monotherapy<br>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<br>* Chemotherapy drug (taxane)<br>|

What is the study measuring?
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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 |