Description:
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
Title
- Brief Title: Efficacy, Safety and Pharmacokinetics of BCD-100 (Anti-PD-1) Monotherapy as Second Line Treatment in Patients With Non-Small Cell Lung Cancer (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 IDs
- ORG STUDY ID:
BCD-100-2/DOMINUS
- NCT ID:
NCT03288870
Conditions
- Non Small Cell Lung Cancer Stage IIIB
- Non-Small Cell Carcinoma of Lung, TNM Stage 4
Interventions
Drug | Synonyms | Arms |
---|
BCD-100 | | BCD-100 monotherapy |
Docetaxel | | Docetaxel monotherapy |
Purpose
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
Trial Arms
Name | Type | Description | Interventions |
---|
BCD-100 monotherapy | Experimental | 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 | Active Comparator | 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 | |
Eligibility 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Overall survival |
Time Frame: | 1 year |
Safety Issue: | |
Description: | Percent of patients who are alive after 1 year of therapy |
Secondary Outcome Measures
Measure: | Overall response rate |
Time Frame: | 1 year |
Safety Issue: | |
Description: | Percent of patients who have complete or partial response to therapy |
Measure: | Progression-free survival |
Time Frame: | 1 year |
Safety Issue: | |
Description: | Percent of patients who are alive after 1 year of therapy |
Details
Phase: | Phase 2/Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Biocad |
Last Updated
October 29, 2020