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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Non Squamous Non Small Cell Lung Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

ltd "Institute of Clinical Oncology"

Tbilisi, Georgia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Stage IV, non squamous NSCLC
Have not received any prior systemic anti-cancer therapy for metastatic NSCLC
Have at least 1 measurable lesion per RECIST version 1.1

Exclusion criteria

Have predominantly squamous cell histology NSCLC.
Hypersensitivity or contraindication to any component of the study drug, pemetrexed and cisplatin or carboplatin

Treatment and study plan

CT-P51

Drug

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

Drug

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

Primary outcomes

ORR based on the confirmed best overall response (BOR) by the end of Cycle 11 according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Time frame: Up to 34 weeks

Sponsors and collaborators

Lead sponsor

Celltrion

Industry

Registry information

Official study 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

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2028
First posted: Apr 23, 2025
Registry last updated: Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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