NCT06939595

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
606

participants targeted

Target at P75+ for phase_3

Timeline
27mo left

Started Jan 2025

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress37%
Jan 2025Jul 2028

Study Start

First participant enrolled

January 30, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 23, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

April 23, 2025

Status Verified

April 1, 2025

Enrollment Period

2 years

First QC Date

April 21, 2025

Last Update Submit

April 21, 2025

Conditions

Non Squamous Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

CT-P51

EXPERIMENTAL
Drug: CT-P51

EU-approved Keytruda

ACTIVE COMPARATOR
Drug: EU-approved Keytruda

Interventions

CT-P51DRUG

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

CT-P51
EU-approved KeytrudaDRUG

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

EU-approved Keytruda

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ltd "Institute of Clinical Oncology"

Tbilisi, Georgia

RECRUITING

Central Study Contacts

Jaeyoung Jang

CONTACT

+82 32 850 5769jaeyoung.jang@celltrion.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2025

First Posted

April 23, 2025

Study Start

January 30, 2025

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

July 1, 2028

Last Updated

April 23, 2025

Record last verified: 2025-04

Locations

GE(1)