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
Overview
- Phase
- Phase 2
- Intervention
- BCD-100
- Conditions
- Non Small Cell Lung Cancer Stage IIIB
- Sponsor
- Biocad
- Enrollment
- 218
- Locations
- 8
- Primary Endpoint
- Overall survival
- Last Updated
- 5 years ago
Overview
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
Investigators
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
Arms & Interventions
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
Intervention: BCD-100
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
Intervention: Docetaxel
Outcomes
Primary Outcomes
Overall survival
Time Frame: 1 year
Percent of patients who are alive after 1 year of therapy
Secondary Outcomes
- Overall response rate(1 year)
- Progression-free survival(1 year)