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A Study to Compare Effects and Safety of CT-P51 and Keytruda in Patients With Previously Untreated Metastatic Lung Cancer
Sponsor: Celltrion
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
606
Start Date
2025-01-30
Completion Date
2028-07
Last Updated
2025-04-23
Healthy Volunteers
No
Conditions
Interventions
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
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
Locations (1)
ltd "Institute of Clinical Oncology"
Tbilisi, Georgia