NCT06939595

A Study to Compare Effects and Safety of CT-P51 and Keytruda in Patients With Previously Untreated Metastatic Lung Cancer

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 606 (estimated)
• Sponsor: Celltrion · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this Phase 3 clinical trial is to compare efficacy and safety of CT-P51 and European Union (EU) approved Keytruda in combination with platinum pemetrexed chemotherapy in patients with previously untreated metastatic nsNSCLC.

Conditions

• Non Squamous Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	CT-P51	CT-P51 200mg with pemetrexed and cisplatin or carboplatin will be administered every 3 weeks for a maximum of 4 cycles followed by CT-P51 or Keytruda and pemetrexed every 3 weeks
DRUG	EU-approved Keytruda	Keytruda 200mg with pemetrexed and cisplatin or carboplatin will be administered every 3 weeks for a maximum of 4 cycles followed by CT-P51 or Keytruda and pemetrexed every 3 weeks

Timeline

• Start date: 2025-01-30
• Primary completion: 2027-02-01
• Completion: 2028-07-01
• First posted: 2025-04-23
• Last updated: 2025-04-23

Locations

1 site across 1 country: Georgia

Regulatory

• FDA-regulated drug study