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

• Status: Active, not recruiting
• Trial end date: 2021-08-10
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biocad
• Treatments: Docetaxel

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