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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

NCT03912389 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 292

Last updated 2020-09-17

No results posted yet for this 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.

Conditions

  • Non-Squamous Non-Small Cell Neoplasm of Lung

Interventions

BIOLOGICAL

BCD-100

Anti-PD-1 monoclonal antibody, IV infusion

DRUG

Pemetrexed

IV infusion

DRUG

Cisplatin (or carboplatin)

IV infusion

OTHER

Placebo

IV infusion

Sponsors & Collaborators

  • Biocad

    lead INDUSTRY

Principal Investigators

  • Yulia N Linkova, MD, PhD · Director of Clinical Development Department, BIOCAD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Czechia
  • Georgia
  • Hungary
  • Romania
  • Russia
  • Slovakia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03912389 on ClinicalTrials.gov