Efficacy, Safety and Pharmacokinetics of BCD-100 (Anti-PD-1) Monotherapy as Second Line Treatment in Patients With Non-Small Cell Lung Cancer (DOMINUS)
- Conditions
- Non Small Cell Lung Cancer Stage IIIBNon-Small Cell Carcinoma of Lung, TNM Stage 4
- Interventions
- Registration Number
- NCT03288870
- Lead Sponsor
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 218
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BCD-100 monotherapy BCD-100 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 Docetaxel monotherapy Docetaxel 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
- Primary Outcome Measures
Name Time Method Overall survival 1 year Percent of patients who are alive after 1 year of therapy
- Secondary Outcome Measures
Name Time Method Overall response rate 1 year Percent of patients who have complete or partial response to therapy
Progression-free survival 1 year Percent of patients who are alive after 1 year of therapy
Trial Locations
- Locations (8)
Arkhangelsk District Clinical Oncology Dispensary
🇷🇺Arkhangelsk, Russian Federation
Gomel Regional Clinical Oncology Dispensary
🇧🇾Gomel, Belarus
N.N.Petrov Oncology Research Center
🇷🇺St.Petersburg, 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
Republican Clinical Oncology Dispensary of Ministry of Health republic Bashkortostan
🇷🇺Ufa, Russian Federation