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

NCT ID: NCT06939595

Last Updated: 2025-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

606 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-30

Study Completion Date

2028-07-31

Brief Summary

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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

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Conditions

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Non Squamous Non Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CT-P51

Group Type EXPERIMENTAL

CT-P51

Intervention Type DRUG

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

EU-approved Keytruda

Group Type ACTIVE_COMPARATOR

EU-approved Keytruda

Intervention Type DRUG

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

Interventions

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CT-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

Intervention Type DRUG

EU-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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Celltrion

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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ltd "Institute of Clinical Oncology"

Tbilisi, , Georgia

Site Status RECRUITING

Countries

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Georgia

Central Contacts

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Jaeyoung Jang

Role: CONTACT

+82 32 850 5769

Facility Contacts

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Vladimer Kuchava

Role: primary

+995 995322 93306163

Other Identifiers

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CT-P51 3.1

Identifier Type: -

Identifier Source: org_study_id

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