Status:
UNKNOWN
Efficacy, Safety and Pharmacokinetics of BCD-100 (Anti-PD-1) Monotherapy as Second Line Treatment in Patients With Non-Small Cell Lung Cancer (DOMINUS)
Lead Sponsor:
Biocad
Conditions:
Non Small Cell Lung Cancer Stage IIIB
Non-Small Cell Carcinoma of Lung, TNM Stage 4
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 pat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 10 2021
Estimated Enrollment :
218 Patients enrolled
Trial Details
Trial ID
NCT03288870
Start Date
September 19 2017
End Date
August 10 2021
Last Update
October 29 2020
Active Locations (8)
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1
Gomel Regional Clinical Oncology Dispensary
Homyel, Belarus
2
Arkhangelsk District Clinical Oncology Dispensary
Arkhangelsk, Russia, 163045
3
Clinical Oncology Dispensary N1
Krasnodar, Russia, 350040
4
N.N. Burdenko General Military Clinical Hospital
Moscow, Russia, 105229