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

Launched by BIOCAD · Sep 19, 2017

Keywords

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ALL

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