Non Small Cell Lung Cancer Stage IIIBPhase 2/3DOMINUSNCT03288870
Efficacy, Safety and Pharmacokinetics of BCD-100 (Anti-PD-1) Monotherapy as Second Line Treatment in Patients With Non-Small Cell Lung Cancer (DOMINUS)
A Phase 2/3 study testing BCD-100 and Docetaxel in people with Non Small Cell Lung Cancer Stage IIIB and Non-Small Cell Carcinoma of Lung, TNM Stage 4, run by Biocad at 8 sites in 2 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer Stage IIIB, Non-Small Cell Carcinoma of Lung, TNM Stage 4
- What is being tested?
- BCD-100 and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 19 Sep 2017to 10 Aug 2021
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Russia7 sites
Arkhangelsk District Clinical Oncology Dispensary
Arkhangelsk, 163045
Clinical Oncology Dispensary N1
Krasnodar, 350040
N.N. Burdenko General Military Clinical Hospital
Moscow, 105229
Pyatigorsk Oncology Center
Pyatigorsk, 357502
Saint Petersburg City Clinical Oncology Center
Saint Petersburg, 197022
N.N.Petrov Oncology Research Center
Saint Petersburg, 197758
Republican Clinical Oncology Dispensary of Ministry of Health republic Bashkortostan
Ufa, 450054
About this study
Official title: 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
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
- Being tested
- BCD-100, Docetaxel
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCD-100Drug
monoclonal antibody to PD-1 receptor
DocetaxelDrug
Chemotherapy drug (taxane)
| Study group | Role | What they receive |
|---|---|---|
| BCD-100 monotherapy | Experimental | 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 Receives: Drug: BCD-100 |
| Docetaxel monotherapy | Active comparator | 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 Receives: Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Percent of patients who are alive after 1 year of therapy
Measured: 1 year
Secondary outcomes (2)
Overall response rate
Percent of patients who have complete or partial response to therapy
Measured: 1 year
Progression-free survival
Percent of patients who are alive after 1 year of therapy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2017
- Study start19 Sep 2017
- Primary completion10 Aug 2020
- Study completion10 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung Cancer Stage IIIBStudies of the same condition, open and under way.
- More trials run by BiocadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 218 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biocad
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roman A Ivanov, PhD, Study director, Vice President R&D, JSC BIOCAD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03288870
- Sponsor's protocol ID
- BCD-100-2/DOMINUS
- Acronym
- DOMINUS
- Status last verified
- Oct 2020
- First submitted
- 23 Aug 2017
- Last updated
- 29 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03288870
- Acronym / sponsor ID
- DOMINUS / BCD-100-2/DOMINUS
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 218 participants (estimated)
- Lead sponsor
- BiocadIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2017 (actual)
- Primary completion
- 10 Aug 2020 (actual)
- Study completion
- 10 Aug 2021 (estimated)
- First posted
- 20 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BCD-100 monotherapy | Experimental | Drug: BCD-100Patients 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 |
| Docetaxel monotherapy | Active comparator | Drug: DocetaxelPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCD-100monoclonal antibody to PD-1 receptor | Drug | BCD-100 monotherapy |
| DocetaxelChemotherapy drug (taxane) | Drug | Docetaxel monotherapy |
Primary outcome
Overall survival
Time frame: 1 year
Percent of patients who are alive after 1 year of therapy
2 secondary outcomes
Overall response rate
Time frame: 1 year
Progression-free survival
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roman A Ivanov, PhD study director
Vice President R&D, JSC BIOCAD
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing BCD-100 and Docetaxel in people with Non Small Cell Lung Cancer Stage IIIB and Non-Small Cell Carcinoma of Lung, TNM Stage 4, run by Biocad at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Russia, Belarus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2020.