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

Celltrion Healthcare

Status and phase: Enrolling; Phase 3

Conditions: Non Squamous Non Small Cell Lung Cancer

Treatments: Drug: EU-approved Keytruda; Drug: CT-P51

Study type: Interventional

Funder types: Industry

Identifiers

NCT06939595

CT-P51 3.1

Details and patient eligibility

About

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.

Enrollment: 606 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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606 participants in 2 patient groups

CT-P51

Experimental group

Treatment:

Drug: CT-P51

EU-approved Keytruda

Active Comparator group

Treatment:

Drug: EU-approved Keytruda