Non Small Cell Lung Cancer Stage IIIB, Non-Small Cell Carcinoma of Lung, TNM Stage 4
Conditions
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
Interventions
DRUGBCD-100
monoclonal antibody to PD-1 receptor
DRUGDocetaxel
Chemotherapy drug (taxane)
Sponsors
Biocad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 1 year | Percent of patients who are alive after 1 year of therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Belarus, Russia
Outcome results
None listed