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

Condition(s) studied

Investigational drug(s) / intervention(s)

SB27: Will be administered intravenously at a fixed dose of 200 mg every 3 weeks

Keytruda: Will be administered intravenously at a fixed dose of 200 mg every 3 weeks

Study 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

Primary outcome measure(s)

• Objective response rate (ORR) at Week 24 — At Week 24
  Defined as the proportion of subjects achieving a complete response (CR) or partial response (PR) at Week 24 according to RECIST v1.1

Trial sites (93)

+ 53 more sites — see the full list on the official registry below.