Clinical Trials /

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

NCT03288870

Description:

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

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2/Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Study of Efficacy, Safety and Pharmacokinetics of BCD-100 Monotherapy as Second Line Treatment of Patients With Non-small Cell Lung Cancer
  • 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 IDs

  • ORG STUDY ID: BCD-100-2/DOMINUS
  • NCT ID: NCT03288870

Conditions

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

Interventions

DrugSynonymsArms
BCD-100BCD-100 monotherapy
DocetaxelDocetaxel monotherapy

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
BCD-100 monotherapyExperimentalPatients 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
  • BCD-100
Docetaxel monotherapyActive ComparatorPatients 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
  • Docetaxel

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall survival
Time Frame:1 year
Safety Issue:
Description:Percent of patients who are alive after 1 year of therapy

Secondary Outcome Measures

Measure:Overall response rate
Time Frame:1 year
Safety Issue:
Description:Percent of patients who have complete or partial response to therapy
Measure:Progression-free survival
Time Frame:1 year
Safety Issue:
Description:Percent of patients who are alive after 1 year of therapy

Details

Phase:Phase 2/Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Biocad

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