Clinical trial · Interventional
Efficacy, Safety and Pharmacokinetics of BCD-100 (Anti-PD-1) Monotherapy as Second Line Treatment in Patients With Non-Small Cell Lung Cancer (DOMINUS)
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Carcinoma of Lung, TNM Stage 4 | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
| Non Small Cell Lung Cancer Stage IIIB | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BCD-100 | Drug | — | UNRESOLVED |
| Docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- BCD-100 monotherapy
- description
- 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
- interventionNames
- Drug: BCD-100
- type
- ACTIVE_COMPARATOR
- label
- Docetaxel monotherapy
- description
- 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
- interventionNames
- Drug: Docetaxel
Primary outcomes (1)
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available