A Double-Blind, Randomized, Active-Controlled, Parallel-Group, Phase 3 Study to Compare Efficacy and Safety of CT-P51 and Keytruda in Combination with Platinum-Pemetrexed Chemotherapy in Patients with Previously Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-514048-98-00

Acronym

CT-P51 3.1

Enrollment

210

Registered

2024-12-12

Start date

2025-01-30

Completion date

Unknown

Last updated

2025-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Previously Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer

Brief summary

ORR (CR + PR) based on the confirmed BOR by the end of Cycle 11 according to RECIST version 1.1 in the ITT set

Interventions

DRUGALIMTA 500 mg powder for concentrate for solution for infusion

DRUGCisplatin Hikma 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGPemetrexed Fresenius Kabi 25 mg/ml concentrate for solution for infusion

DRUGCarboplatin Hikma 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGPembrolizumab

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
ORR (CR + PR) based on the confirmed BOR by the end of Cycle 11 according to RECIST version 1.1 in the ITT set	—

Countries

Croatia, Greece, Lithuania, Poland, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026