International Multicenter Randomized Double-Blind Placebo-Controlled Clinical Trial Evaluating Efficacy and Safety Of BCD-100 in Combination With Pemetrexed+Cisplatin/Carboplatin Compared to Placebo in Combination With Pemetrexed+Cisplatin/Carboplatin as First-Line Treatment of Subjects With Advanced Non-squamous Non-Small Cell Lung Cancer (NSCLC)

Biocad37 sites in 6 countries292 target enrollmentJune 1, 2019

ConditionsNon-Squamous Non-Small Cell Neoplasm of Lung

InterventionsBCD-100 Pemetrexed Cisplatin (or carboplatin)Placebo

DrugsPemetrexed Cisplatin (or carboplatin)

Overview

Phase: Phase 3
Intervention: BCD-100
Conditions: Non-Squamous Non-Small Cell Neoplasm of Lung
Sponsor: Biocad
Enrollment: 292
Locations: 37
Primary Endpoint: Overall Survival (OS)
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

June 1, 2019

End Date

December 2023

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Biocad

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject has voluntarily agreed to participate by giving written informed consent for the trial;
•Patients ≥ 18 years of age on day of signing informed consent;
•Previously untreated patients with histologically-confirmed stage IV (M1a/M1b/M1c- AJCC 8th edition) non-squamous NSCLC;
•Has not received prior systemic treatment for metastatic NSCLC;
•The time from the completion of previous adjuvant/neoadjuvant treatment to metastatic disease development is no less than 12 months;
•Has a life expectancy of at least 12 weeks;
•Has Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
•Has adequate organ function as defined by hematological laboratory values (absolute neutrophil count ≥1.500/mcL, platelets ≥100.000/mcL, hemoglobin ≥9 g/dL ), renal laboratory values (serum creatinine or calculated creatinine clearance \<1.5xULN or ≥60 mL/min for subjects with creatinine levels\>1.5x institutional ULN), and hepatic laboratory values (serum total bilirubin \<1.5xULN, AST and ALT ≤2.5xULN, alkaline phosphatase \<2.5xULN);
•Agreement to newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for determination of PD-L1 status prior to randomization (if obtaining of new sample is contraindicated or puts subject at unacceptable risks, then archival tumor tissue sample must be available)
•Measurable disease according to CT scan (RECIST 1.1 criteria) , confirmed by the local assessment;

Exclusion Criteria

•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.
•Presence of EGFR mutation or ALK translocation;
•Has received prior systemic cytotoxic chemotherapy/chemoradiotherapy for metastatic disease;
•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;
•Completed radiation therapy within 14 days before the first dose of the study drug;
•Received a live-virus vaccination within 30 days prior to the first study drug administration;
•Current treatment in another investigational device or drug study, or less than 28 days since ending treatment on another investigational device or drug study;
•Had major surgery less than 28 days prior to the first dose of the study drug;
•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;
•Concomitant diseases or conditions which pose a risk of AE development during study treatment: