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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
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

NCT06348199

Active Not RecruitingPhase 3

Sponsor: Samsung Bioepis Co., Ltd.

Conditions: Non-small Cell Lung Cancer Stage IV

Interventions: SB27, Keytruda

Countries: Bosnia and Herzegovina, Brazil, Georgia, Germany, India, Japan, Malaysia, Mexico

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 overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (93)
  • Banja Luka, Bosnia and Herzegovina
  • Mostar, Bosnia and Herzegovina
  • Sarajevo, Bosnia and Herzegovina
  • Curitiba, Brazil
  • Florianópolis, Brazil
  • Ijuí, Brazil
  • Natal, Brazil
  • Pelotas, Brazil
  • Porto Alegre, Brazil
  • Porto Alegre, Brazil
  • Rio de Janeiro, Brazil
  • Santo André, Brazil
  • Batumi, Georgia
  • Tbilisi, Georgia
  • Tbilisi, Georgia
  • Tbilisi, Georgia
  • Tbilisi, Georgia
  • Tbilisi, Georgia
  • Tbilisi, Georgia
  • Düsseldorf, Germany
  • Halle, Germany
  • Moers, Germany
  • Neuss, Germany
  • Bangalore, India
  • Bhubaneswar, India
  • Erandwane, India
  • Hyderabad, India
  • Jaipur, India
  • Jaipur, India
  • Mumbai, India
  • + 63 more on CT.gov