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

Biocad

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Non Small Cell Lung Cancer Stage IIIB; Non-Small Cell Carcinoma of Lung, TNM Stage 4

Treatments: Drug: Docetaxel; Drug: BCD-100

Study type: Interventional

Funder types: Industry

Identifiers

NCT03288870

BCD-100-2/DOMINUS

Details and patient eligibility

About

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

Enrollment: 218 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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218 participants in 2 patient groups

BCD-100 monotherapy

Experimental group

Description:

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

Treatment:

Drug: BCD-100

Docetaxel monotherapy

Active Comparator group

Description:

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

Treatment:

Drug: Docetaxel