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

Last updated: September 15, 2020
Sponsor: Biocad
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT03912389
BCD-100-3
  • Ages > 18
  • All Genders

Study Summary

This is a randomized, multicenter, double-blind placebo-controlled phase 3 study of efficacy and safety of BCD-100 in combination with pemetrexed+cisplatin/carboplatin compared to placebo in combination with pemetrexed+cisplatin/carboplatin in subjects with previously untreated metastatic non-squamous NSCLC. The main hypothesis of the study is that BCD-100 in combination with chemotherapy prolongs OS compared to placebo with chemotherapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject has voluntarily agreed to participate by giving written informed consent forthe trial;

  2. Patients ≥ 18 years of age on day of signing informed consent;

  3. Previously untreated patients with histologically-confirmed stage IV (M1a/M1b/M1c-AJCC 8th edition) non-squamous NSCLC;

  4. Has not received prior systemic treatment for metastatic NSCLC;

  5. The time from the completion of previous adjuvant/neoadjuvant treatment to metastaticdisease development is no less than 12 months;

  6. Has a life expectancy of at least 12 weeks;

  7. Has Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;

  8. Has adequate organ function as defined by hematological laboratory values (absoluteneutrophil count ≥1.500/mcL, platelets ≥100.000/mcL, hemoglobin ≥9 g/dL ), renallaboratory values (serum creatinine or calculated creatinine clearance <1.5xULN or ≥60mL/min for subjects with creatinine levels>1.5x institutional ULN), and hepaticlaboratory values (serum total bilirubin <1.5xULN, AST and ALT ≤2.5xULN, alkalinephosphatase <2.5xULN);

  9. Agreement to newly obtained core or excisional biopsy of a tumor lesion not previouslyirradiated for determination of PD-L1 status prior to randomization (if obtaining ofnew sample is contraindicated or puts subject at unacceptable risks, then archivaltumor tissue sample must be available)

  10. Measurable disease according to CT scan (RECIST 1.1 criteria) , confirmed by the localassessment;

  11. For subjects of childbearing potential: agreement to remain abstinent (refrain fromheterosexual inter-course) or use a contraceptive method with a failure rate of < 1%per year during the treatment period and for at least 6 months after administration ofthe last dose of study drug; and 6 months after the last dose of platinum-basedchemotherapy, whichever is later. A woman is considered to be of childbearingpotential if she is postmenarcheal, has not reached a postmenopausal state (≥ 12continuous months of amenorrhea with no identified cause other than menopause), andhas not undergone surgical sterilization (removal of ovaries, fallopian tubes, and/oruterus). Examples of contraceptive methods with a failure rate of < 1% per yearinclude but are not limited to bilateral tubal ligation and/or occlusion, malesterilization, and intrauterine devices. The reliability of sexual abstinence shouldbe evaluated in relation to the duration of the clinical study and the preferred andusual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation,symptothermal, or postovulation methods) and withdrawal are not acceptable methods ofcontraception.

Exclusion

Exclusion Criteria:

  1. Has predominantly squamous cell histology NSCLC; Mixed tumors will be categorized bythe predominant cell type; if small cell elements are present, the subject isineligible.

  2. Presence of EGFR mutation or ALK translocation;

  3. Has received prior systemic cytotoxic chemotherapy/chemoradiotherapy for metastaticdisease;

  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 torequire 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 drugadministration;

  7. Current treatment in another investigational device or drug study, or less than 28days 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 maincondition (including but not limited to massive pleural, pericardial, or peritonealeffusion 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 studytreatment:

  11. uncontrolled hypertension, defined as systolic > 150 mm Hg or diastolic > 90 mmHg; define diagnosis of hypertension

  12. stable angina functional class III-IV;

  13. unstable angina or myocardial infarction less than 6 months prior torandomization;

  14. NYHA Grade III-IV congestive heart failure;

  15. serious cardiac arrhythmia requiring medication (subjects with asymptomaticatrial fibrillation can be enrolled if controlled ventricular rate);

  16. atopic asthma, Stage III-IV COPD, angioedema;

  17. severe respiratory failure;

  18. any other diseases which pose unacceptable risk of AE development during studytreatment in Investigator's opinion;

  19. Has known active central nervous system (CNS) metastases and/or carcinomatousmeningitis ;

  20. Active or known or suspected autoimmune disease (subjects with Type 1 diabetesmellitus, hypothyroidism only requiring hormone replacement, or skin disorders (vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted toenroll).

  21. Has clinically active diverticulitis, intra-abdominal abscess, GI obstruction,abdominal carcinomatosis;

  22. Has interstitial lung disease or a history of pneumonitis that required oral orintravenous glucocorticoids to assist with management. Lymphangitic spread of theNSCLC is not exclusionary;

  23. Condition requiring systemic treatment with either corticosteroids or otherimmunosuppressive medications in past 2 years;

  24. Is unable or unwilling to take folic acid or vitamin B12 supplementation;

  25. Known history of prior malignancy except if participant has undergone potentiallycurative therapy with no evidence of that disease recurrence for 2 years sinceinitiation of that therapy, except for successful definitive resection of basal cellcarcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of theskin, in situ cervical cancer, or other in situ cancers;

  26. Pre-existing clinically significant (≥ grade 2) peripheral neuropathy or hearingimpairment;

  27. Any conditions or circumstances that limit subject's ability to comply with protocolrequirements;

  28. Active hepatitis B, hepatitis С or HIV in anamnesis;

  29. Acute infection or reactivation of chronic infection or systemic antibiotics use lessthan 14 days prior to first dose of the study drug; Severe infections within 28 daysprior to the first study drug administration.

  30. Significant adverse reactions of previous therapy excluding chronic and/orirreversible events which cannot affect study drug safety evaluation (e.g. alopecia);

  31. Known hypersensitivity or allergy to drugs containing Chinese hamster (CHO) ovarycells or history of severe allergic, anaphylactic, or other hypersensitivity reactionsto chimeric or humanized antibodies or fusion proteins, to pemetrexed, carboplatin,cisplatin, BCD-100 or any of their excipients;

  32. Is pregnant or breastfeeding, or expecting to conceive or father children within theprojected duration of the study.

Study Design

Total Participants: 292
Study Start date:
June 01, 2019
Estimated Completion Date:
December 31, 2023

Connect with a study center

  • Regional Hospital Liberec

    Liberec,
    Czechia

    Active - Recruiting

  • University Hospital Olomouc

    Olomouc,
    Czechia

    Active - Recruiting

  • University Hospital Ostrava

    Ostrava,
    Czechia

    Active - Recruiting

  • Multiscan Pardubice - Radiology Center

    Pardubice,
    Czechia

    Active - Recruiting

  • High technology Hospital Medcenter

    Batumi,
    Georgia

    Active - Recruiting

  • Acad. F.Todua Medical center "Research institute of Clinical Medicine"

    Tbilisi,
    Georgia

    Active - Recruiting

  • High Technology Medical Centre, University Clinic

    Tbilisi,
    Georgia

    Active - Recruiting

  • Institute for Personalized Medicine Ltd.

    Tbilisi,
    Georgia

    Active - Recruiting

  • LEPL First University Clinic of Tbilisi State Medical University

    Tbilisi,
    Georgia

    Active - Recruiting

  • National Korányi Institute of Pulmonology IV. Pulmonology

    Budapest,
    Hungary

    Active - Recruiting

  • Semmelweis University Pulmonology Clinic

    Budapest,
    Hungary

    Active - Recruiting

  • Mátra Health Institution Pulmonology

    Mátraháza,
    Hungary

    Active - Recruiting

  • S.C Radiotherapy Center Cluj S.R.L

    Cluj,
    Romania

    Active - Recruiting

  • S.C Medisprof S.R.L

    Cluj-Napoca,
    Romania

    Active - Recruiting

  • "Sfantul Nectarie" Oncology Center SRL

    Craiova,
    Romania

    Active - Recruiting

  • S.C Oncolab S.R.L

    Craiova,
    Romania

    Active - Recruiting

  • S.C Pelican Impex S.R.L

    Oradea,
    Romania

    Active - Recruiting

  • Emergency Clinical Municipal Hospital Timisoara - Medical Oncology Clinic

    Timisoara,
    Romania

    Active - Recruiting

  • S.C Oncocenter Clinical Oncology S.R.L

    Timisoara,
    Romania

    Active - Recruiting

  • S.C Oncomed S.R.L

    Timisoara,
    Romania

    Active - Recruiting

  • S.C Salvosan Ciobanca S.R.

    Zalau,
    Romania

    Active - Recruiting

  • Arkhangelsk Clinical Oncology Dispensary

    Arkhangel'sk,
    Russian Federation

    Active - Recruiting

  • City Hospital No. 5

    Barnaul,
    Russian Federation

    Active - Recruiting

  • Krasnoyarsk Regional Clinical Oncological Dispensary named after A.I. Kryzhanovsky

    Krasnoyarsk,
    Russian Federation

    Active - Recruiting

  • Moscow City Oncology Hospital No. 62

    Moscow,
    Russian Federation

    Active - Recruiting

  • Clinical Oncology Dispensary

    Omsk,
    Russian Federation

    Active - Recruiting

  • LLC "New Clinic"

    Pyatigorsk,
    Russian Federation

    Active - Recruiting

  • AV Medical Group

    Saint Petersburg,
    Russian Federation

    Active - Recruiting

  • LLC BioEk

    Saint Petersburg,
    Russian Federation

    Active - Recruiting

  • Regional Clinical Oncology Hospital

    Yaroslavl,
    Russian Federation

    Active - Recruiting

  • St. Jacob's Hospital

    Bardejov,
    Slovakia

    Active - Recruiting

  • Hospital Komarno a.s.

    Komarno,
    Slovakia

    Active - Recruiting

  • Eastern Slovak Oncology Institute

    Košice,
    Slovakia

    Active - Recruiting

  • Faculty Hospital with Policlinic of Stefan Kukura

    Michalovce,
    Slovakia

    Active - Recruiting

  • Faculty Hospital with Policlinic

    Nove Zamky,
    Slovakia

    Active - Recruiting

  • Outpatient Oncology Clinic

    Partizanske,
    Slovakia

    Active - Recruiting

  • Faculty Hospital of J.A. Reiman

    Presov,
    Slovakia

    Active - Recruiting

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