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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03288870 |
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Date of registration:
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23/08/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Efficacy, Safety and Pharmacokinetics of BCD-100 (Anti-PD-1) Monotherapy as Second Line Treatment in Patients With Non-Small Cell Lung Cancer (DOMINUS)
DOMINUS |
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Scientific title:
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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 |
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Date of first enrolment:
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September 19, 2017 |
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Target sample size:
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218 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03288870 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Belarus
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Russian Federation
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Contacts
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Name:
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Roman A Ivanov, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Vice President R&D, JSC BIOCAD |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Non Small Cell Lung Cancer Stage IIIB
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Non-Small Cell Carcinoma of Lung, TNM Stage 4
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Intervention(s)
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Drug: Docetaxel
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Drug: BCD-100
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Primary Outcome(s)
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Overall survival
[Time Frame: 1 year]
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Secondary Outcome(s)
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Progression-free survival
[Time Frame: 1 year]
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Overall response rate
[Time Frame: 1 year]
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Secondary ID(s)
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BCD-100-2/DOMINUS
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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