Trial Title:
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
NCT ID:
NCT06348199
Condition:
Non-small Cell Lung Cancer Stage IV
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Pembrolizumab
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
SB27
Description:
Will be administered intravenously at a fixed dose of 200 mg every 3 weeks
Arm group label:
SB27
Intervention type:
Drug
Intervention name:
Keytruda
Description:
Will be administered intravenously at a fixed dose of 200 mg every 3 weeks
Arm group label:
Keytruda
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
SB Investigative Site
Address:
City:
Banja Luka
Country:
Bosnia and Herzegovina
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Mostar
Country:
Bosnia and Herzegovina
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Sarajevo
Country:
Bosnia and Herzegovina
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Curitiba
Country:
Brazil
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Florianópolis
Country:
Brazil
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Ijui
Country:
Brazil
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Natal
Country:
Brazil
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Pelotas
Country:
Brazil
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Porto Alegre
Country:
Brazil
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Rio De Janeiro
Country:
Brazil
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Santo André
Country:
Brazil
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Batumi
Country:
Georgia
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Tbilisi
Country:
Georgia
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Düsseldorf
Country:
Germany
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Giessen
Country:
Germany
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Halle
Country:
Germany
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Kassel
Country:
Germany
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Moers
Country:
Germany
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Neuss
Country:
Germany
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Bangalore
Country:
India
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Bhubaneshwar
Country:
India
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Bhubaneswar
Country:
India
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Erandwane
Country:
India
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Hyderabad
Country:
India
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Jaipur
Country:
India
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Mumbai
Country:
India
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Sūrat
Country:
India
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Udaipur
Country:
India
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Himeji
Country:
Japan
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Iwakuni
Country:
Japan
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Izumi
Country:
Japan
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Kawachi-Nagano
Country:
Japan
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Kobe
Country:
Japan
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Kochi
Country:
Japan
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Okayama
Country:
Japan
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Sagamihara
Country:
Japan
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Tachikawa
Country:
Japan
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Takarazuka
Country:
Japan
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Toyonaka
Country:
Japan
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
George Town
Country:
Malaysia
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Johor Bahru
Country:
Malaysia
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Kota Bharu
Country:
Malaysia
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Kuantan
Country:
Malaysia
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Lembah Pantai
Country:
Malaysia
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Putrajaya
Country:
Malaysia
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Aguascalientes
Country:
Mexico
Status:
Not yet recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Ciudad De México
Country:
Mexico
Status:
Not yet recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Guadalajara
Country:
Mexico
Status:
Not yet recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Davao City
Country:
Philippines
Status:
Not yet recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Makati City
Country:
Philippines
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Manila
Country:
Philippines
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Quezon City
Country:
Philippines
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
San Juan City
Country:
Philippines
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Cluj-Napoca
Country:
Romania
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Craiova
Country:
Romania
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Iaşi
Country:
Romania
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Oradea
Country:
Romania
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Sibiu
Country:
Romania
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Suceava
Country:
Romania
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Timişoara
Country:
Romania
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Târgu-Mureş
Country:
Romania
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Belgrade
Country:
Serbia
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Kragujevac
Country:
Serbia
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Nis
Country:
Serbia
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Sremska Kamenica
Country:
Serbia
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Leganés
Country:
Spain
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Madrid
Country:
Spain
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Málaga
Country:
Spain
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Ourense
Country:
Spain
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Oviedo
Country:
Spain
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Pamplona
Country:
Spain
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Santiago De Compostela
Country:
Spain
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Sevilla
Country:
Spain
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Valencia
Country:
Spain
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Bangkok Noi
Country:
Thailand
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Bangkok
Country:
Thailand
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Khon Kaen
Country:
Thailand
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Adapazarı
Country:
Turkey
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Ankara
Country:
Turkey
Status:
Not yet recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Istanbul
Country:
Turkey
Status:
Not yet recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Izmit
Country:
Turkey
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Kavaklıdere
Country:
Turkey
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Maltepe
Country:
Turkey
Status:
Recruiting
Facility:
Name:
SB Investigative Site
Address:
City:
Sivas
Country:
Turkey
Status:
Recruiting
Start date:
March 12, 2024
Completion date:
March 2027
Lead sponsor:
Agency:
Samsung Bioepis Co., Ltd.
Agency class:
Industry
Source:
Samsung Bioepis Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06348199
