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NCT03288870 Clinical 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)

Non-Small Cell Carcinoma of Lung, TNM Stage 4 Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03288870
Other study ID # BCD-100-2/DOMINUS
Secondary ID
Status Active, not recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date September 19, 2017
Est. completion date August 10, 2021

Study information
Verified date October 2020
Source Biocad
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 218
Est. completion date August 10, 2021
Est. primary completion date August 10, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• BCD-100
monoclonal antibody to PD-1 receptor
• Docetaxel
Chemotherapy drug (taxane)

Locations
Country Name City State
Belarus Gomel Regional Clinical Oncology Dispensary Gomel
Russian Federation Arkhangelsk District Clinical Oncology Dispensary Arkhangelsk
Russian Federation Clinical Oncology Dispensary N1 Krasnodar
Russian Federation N.N. Burdenko General Military Clinical Hospital Moscow
Russian Federation Pyatigorsk Oncology Center Pyatigorsk
Russian Federation Saint Petersburg City Clinical Oncology Center Saint Petersburg
Russian Federation N.N.Petrov Oncology Research Center St.Petersburg
Russian Federation Republican Clinical Oncology Dispensary of Ministry of Health republic Bashkortostan Ufa

Sponsors (1)
Lead Sponsor Collaborator
Biocad

Countries where clinical trial is conducted

Belarus,  Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall survival Percent of patients who are alive after 1 year of therapy 1 year
Secondary Overall response rate Percent of patients who have complete or partial response to therapy 1 year
Secondary Progression-free survival Percent of patients who are alive after 1 year of therapy 1 year
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