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

Last updated: April 21, 2025
Sponsor: Celltrion
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

EU-approved Keytruda

CT-P51

Clinical Study ID

NCT06939595
CT-P51 3.1
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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

Exclusion Criteria:

  • Have predominantly squamous cell histology NSCLC.

  • Hypersensitivity or contraindication to any component of the study drug, pemetrexedand cisplatin or carboplatin

Study Design

Total Participants: 606
Treatment Group(s): 2
Primary Treatment: EU-approved Keytruda
Phase: 3
Study Start date:
January 30, 2025
Estimated Completion Date:
July 31, 2028

Connect with a study center

  • ltd "Institute of Clinical Oncology"

    Tbilisi,
    Georgia

    Active - Recruiting

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