NCT03912389

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

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)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 292 (estimated)
• Sponsor: Biocad · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
BIOLOGICAL	BCD-100	Anti-PD-1 monoclonal antibody, IV infusion
DRUG	Pemetrexed	IV infusion
DRUG	Cisplatin (or carboplatin)	IV infusion
OTHER	Placebo	IV infusion

Timeline

• Start date: 2019-06-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2019-04-11
• Last updated: 2020-09-17

Locations

37 sites across 6 countries: Czechia, Georgia, Hungary, Romania, Russia, Slovakia