RecruitingPhase 3NCT06939595

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

Sponsor

Celltrion

Enrollment

606 participants

Start Date

Jan 30, 2025

Study Type

INTERVENTIONAL

Conditions

Non-squamous Non-small Cell Lung Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a biosimilar version of pembrolizumab (called CT-P51) against the original pembrolizumab (Keytruda) in combination with chemotherapy for people with advanced, previously untreated non-squamous non-small cell lung cancer. A biosimilar is a near-identical version of an approved biologic drug. This study aims to confirm the biosimilar works just as well and is just as safe. **You may be eligible if...** - You have stage IV (metastatic) non-squamous non-small cell lung cancer - You have not received any prior treatment for your metastatic lung cancer - You have at least one measurable tumor **You may NOT be eligible if...** - Your lung cancer is predominantly squamous cell type - You have a known allergy or contraindication to any component of the study drugs, including pemetrexed or the platinum-based chemotherapy (cisplatin or carboplatin) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCT-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

DRUGEU-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

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NCT06939595

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