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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
555
Will be administered intravenously at a fixed dose of 200 mg every 3 weeks
Will be administered intravenously at a fixed dose of 200 mg every 3 weeks
SB Investigative Site
Banja Luka, Bosnia and Herzegovina
SB Investigative Site
Mostar, Bosnia and Herzegovina
SB Investigative Site
Sarajevo, Bosnia and Herzegovina
SB Investigative Site
Curitiba, Brazil
SB Investigative Site
Florianópolis, Brazil
SB Investigative Site
Objective response rate (ORR) 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
Time frame: At Week 24
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Ijuí, Brazil
SB Investigative Site
Natal, Brazil
SB Investigative Site
Pelotas, Brazil
SB Investigative Site 1
Porto Alegre, Brazil
SB Investigative Site 2
Porto Alegre, Brazil
...and 83 more locations