Efficacy, Safety and Pharmacokinetics of BCD-100 (Anti-PD-1) Monotherapy as Second Line Treatment in Patients With Non-Small Cell Lung Cancer (DOMINUS)

Non-Small Cell Carcinoma of Lung, TNM Stage 4 Clinical Trial

— DOMINUS  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03288870
• Other study ID #: BCD-100-2/DOMINUS
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: September 19, 2017
• Est. completion date: August 10, 2021

Study information

• Verified date: October 2020
• Source: Biocad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 218
• Est. completion date: August 10, 2021
• Est. primary completion date: August 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer Stage IIIB
• Non-Small Cell Carcinoma of Lung, TNM Stage 4

Intervention

Drug:
• BCD-100
monoclonal antibody to PD-1 receptor
• Docetaxel
Chemotherapy drug (taxane)

Locations

Country	Name	City	State
Belarus	Gomel Regional Clinical Oncology Dispensary	Gomel
Russian Federation	Arkhangelsk District Clinical Oncology Dispensary	Arkhangelsk
Russian Federation	Clinical Oncology Dispensary N1	Krasnodar
Russian Federation	N.N. Burdenko General Military Clinical Hospital	Moscow
Russian Federation	Pyatigorsk Oncology Center	Pyatigorsk
Russian Federation	Saint Petersburg City Clinical Oncology Center	Saint Petersburg
Russian Federation	N.N.Petrov Oncology Research Center	St.Petersburg
Russian Federation	Republican Clinical Oncology Dispensary of Ministry of Health republic Bashkortostan	Ufa

Sponsors (1)

Lead Sponsor	Collaborator
Biocad

Countries where clinical trial is conducted

Belarus,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Percent of patients who are alive after 1 year of therapy	1 year
Secondary	Overall response rate	Percent of patients who have complete or partial response to therapy	1 year
Secondary	Progression-free survival	Percent of patients who are alive after 1 year of therapy	1 year