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Active Not Recruiting NCT06348199

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

Conditions: Non-small Cell Lung Cancer Stage IV

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 555
Sponsor: Samsung Bioepis Co., Ltd.

Location: SB Investigative Site Banja Luka

Summary

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.

Eligibility Criteria

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06348199). StuddyBuddy aggregates publicly available trial information.