A Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer

Samsung

Status and phase: Active, not recruiting; Phase 3

Conditions: Non-small Cell Lung Cancer Stage IV

Treatments: Drug: SB27; Drug: Keytruda

Study type: Interventional

Funder types: Industry

Identifiers

NCT06348199

SB27-3004

Details and patient eligibility

About

The goal of this clinical trial is to confirm that SB27 works in the same way as Keytruda in metastatic non-squamous non-small cell lung cancer (NSCLC) patients. The main question it aims to answer is:

• How effective the study drug is Participants will receive either investigational product (SB27 or Keytruda) and chemotherapy every 3 weeks.

Researchers will compare SB27 and Keytruda to see if SB27 works in the same way as Keytruda.

Enrollment: 555 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female ≥ 18 years of age
• Have been diagnosed with stage IV non-squamous NSCLC
• Have not received any prior systemic anti-cancer therapy for metastatic NSCLC
• Agree to use adequate methods of contraception

Exclusion criteria

• Unable or unwilling to take folic acid and vitamin B12 supplementation
• Severe hypersensitivity to treatment with another monoclonal antibody, any ingredient contained in SB27 or Keytruda, or any component of platinum-containing compounds or pemetrexed.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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555 participants in 2 patient groups

SB27

Experimental group

Description:

SB27 will be administered followed by Pemetrexed and Carboplatin (Carboplatin will be administered for the first 4 cycles).

Treatment:

Drug: SB27

Keytruda

Active Comparator group

Description:

Keytruda will be administered followed by Pemetrexed and Carboplatin (Carboplatin will be administered for the first 4 cycles).

Treatment:

Drug: Keytruda