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

NCT06939595 · Celltrion

Recruiting

In plain English

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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

About this study

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.

Eligibility criteria

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

Study design

Enrollment target: 606 participants

Allocation: randomized

Masking: quadruple

Age groups: adult, older_adult

Timeline

Starts: 2025-01-30

Estimated completion: 2028-07

Last updated: 2025-04-23

Interventions

Drug: CT-P51Drug: EU-approved Keytruda

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 (Up to 34 weeks)

Sponsor

Celltrion · industry

Contacts & investigators

ContactJaeyoung Jang · contact · jaeyoung.jang@celltrion.com · +82 32 850 5769

All locations (1)

ltd "Institute of Clinical Oncology"Recruiting

Tbilisi, Georgia

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