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

Phase 3

Recruiting

• Conditions: Non Squamous Non Small Cell Lung Cancer
• Interventions: Drug: CT-P51; Drug: EU-approved Keytruda

• Registration Number: NCT06939595
• Lead Sponsor: Celltrion

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-30
• Status Verified: 2025-04
• Study First Submitted: 2025-04-21
• Study First Submitted QC: 2025-04-21
• Last Update Submitted: 2025-04-21
• Study First Posted: 2025-04-23
• Last Update Posted: 2025-04-23
• Primary Completion: 2027-02
• Study Completion: 2028-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 606

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CT-P51	CT-P51	-
EU-approved Keytruda	EU-approved Keytruda	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

ltd "Institute of Clinical Oncology"; 🇬🇪 Tbilisi, Georgia