Efficacy and Safety of BCD-100 (Anti-PD-1) in Combination With Platinum-Based Chemotherapy as First Line Treatment in Patients With Advanced Non-Squamous NSCLC

Exclusion Criteria

• •1. Has predominantly squamous cell histology NSCLC; Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the subject is ineligible.
• •2. Presence of EGFR mutation or ALK translocation;
• •3. Has received prior systemic cytotoxic chemotherapy/chemoradiotherapy for metastatic disease;
• •4. Has received antineoplastic therapy with targeted or immunotherapeutic drugs (including but not limited to EGFR inhibitors \[e.g., erlotinib, gefitinib, cetuximab\], ALK inhibitors, PD-1/PD-L1/PD-L2/CTLA4, VEGF/VEGFR inhibitors) or it is expected to require any other form of antineoplastic therapy while on study;
• •5. Completed radiation therapy within 14 days before the first dose of the study drug;
• •6. Received a live-virus vaccination within 30 days prior to the first study drug administration;
• •7. Current treatment in another investigational device or drug study, or less than 28 days since ending treatment on another investigational device or drug study;
• •8. Had major surgery less than 28 days prior to the first dose of the study drug;
• •9. Evidence of severe or concomitant diseases/life-threatening complications of the main condition (including but not limited to massive pleural, pericardial, or peritoneal effusion that requires medical intervention , pulmonary lymphangitis, hemorrhage, organ perforation) at the signing of the informed consent;
• •10. Concomitant diseases or conditions which pose a risk of AE development during study treatment:
• •1. uncontrolled hypertension, defined as systolic \> 150 mm Hg or diastolic \> 90 mm Hg; define diagnosis of hypertension
• •2. stable angina functional class III-IV;
• •3. unstable angina or myocardial infarction less than 6 months prior to randomization;
• •4. NYHA Grade III-IV congestive heart failure;
• •5. serious cardiac arrhythmia requiring medication (subjects with asymptomatic atrial fibrillation can be enrolled if controlled ventricular rate);
• •6. atopic asthma, Stage III-IV COPD, angioedema;
• •7. severe respiratory failure;
• •8. any other diseases which pose unacceptable risk of AE development during study treatment in Investigator's opinion;
• •11. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis ;
• •12. Active or known or suspected autoimmune disease (subjects with Type 1 diabetes mellitus, hypothyroidism only requiring hormone replacement, or skin disorders (vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll).
• •13. Has clinically active diverticulitis, intra-abdominal abscess, GI obstruction, abdominal carcinomatosis;
• •14. Has interstitial lung disease or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management. Lymphangitic spread of the NSCLC is not exclusionary;
• •15. Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications in past 2 years;
• •16. Is unable or unwilling to take folic acid or vitamin B12 supplementation;
• •17. Known history of prior malignancy except if participant has undergone potentially curative therapy with no evidence of that disease recurrence for 2 years since initiation of that therapy, except for successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers;
• •18. Pre-existing clinically significant (≥ grade 2) peripheral neuropathy or hearing impairment;
• •19. Any conditions or circumstances that limit subject's ability to comply with protocol requirements;
• •20. Active hepatitis B, hepatitis С or HIV in anamnesis;
• •21. Acute infection or reactivation of chronic infection or systemic antibiotics use less than 14 days prior to first dose of the study drug; Severe infections within 28 days prior to the first study drug administration.
• •22. Significant adverse reactions of previous therapy excluding chronic and/or irreversible events which cannot affect study drug safety evaluation (e.g. alopecia);
• •23. Known hypersensitivity or allergy to drugs containing Chinese hamster (CHO) ovary cells or history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins, to pemetrexed, carboplatin, cisplatin, BCD-100 or any of their excipients;
• •24. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.