NCT06687369 - A Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) to Keytruda® in Non-small Cell Lung Cancer (BENITO Study) | Biotech Hunter

Enrollment

726

Participants

Timeline

Start Date

December 30, 2024

Primary Completion Date

June 30, 2026

Study Completion Date

September 30, 2027

Conditions

Non Squamous Non Small Cell Lung Cancer

Interventions

DRUG

MB12 (Proposed Pembrolizumab Biosimilar)

200mg IV, every 3 weeks on Day 1

DRUG

EU-sourced Keytruda®

200mg IV, every 3 weeks on Day 1

DRUG

US-sourced Keytruda®

200mg IV, every 3 weeks on Day 1

DRUG

Pemetrexed

500 mg/m2 IV, every 3 weeks on Day 1

DRUG

Carboplatin

Area under the curve (AUC) 5 IV, every 3 weeks on Day 1 for 4 cycles.

DRUG

Cisplatin

75 mg/m2 IV, every 3 weeks on Day 1 for 4 cycles

Trial Locations (18)

Unknown

RECRUITING

Site 108004, Batumi

RECRUITING

Site 108005, Kutaisi

RECRUITING

Site 108011, Marneuli

RECRUITING

Site 108002, Tbilisi

RECRUITING

Site 108003, Tbilisi

RECRUITING

Site 108006, Tbilisi

RECRUITING

Site 108007, Tbilisi

RECRUITING

Site 108009, Tbilisi

RECRUITING

Site 207002, Hakodate-shi

RECRUITING

Site 207012, Okayama

RECRUITING

Site 207010, Shinagawa-Ku

RECRUITING

Site 207001, Shizuoka

RECRUITING

Research site 116001, Chisinau

RECRUITING

Site 121001, Belgrade

RECRUITING

Site 121002, Belgrade

RECRUITING

Site 121004, Kamenitz

RECRUITING

Site 121003, Kragujevac

RECRUITING

Site 121005, Užice

All Listed Sponsors

lead

mAbxience Research S.L.

INDUSTRY