Clinical trial 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
Official title: A Phase III Randomised, Double-blind, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 (Proposed Pembrolizumab Biosimilar) and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Non-small Cell Lung Cancer Stage IV
Lead sponsor: Samsung Bioepis Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-04-04
Enrollment: 616
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Objective response rate (ORR) at Week 24
timeFrame: At Week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Banja Luka
country: Bosnia and Herzegovina
facility: SB Investigative Site
city: Mostar
country: Bosnia and Herzegovina
facility: SB Investigative Site
city: Sarajevo
country: Bosnia and Herzegovina
facility: SB Investigative Site
city: Curitiba
country: Brazil
facility: SB Investigative Site
city: Florianópolis
country: Brazil
facility: SB Investigative Site
city: Ijui
country: Brazil
facility: SB Investigative Site
city: Natal
country: Brazil
facility: SB Investigative Site
city: Pelotas
country: Brazil
facility: SB Investigative Site
city: Porto Alegre
country: Brazil
facility: SB Investigative Site
city: Rio De Janeiro
country: Brazil
facility: SB Investigative Site
city: Santo André
country: Brazil
facility: SB Investigative Site
city: Batumi
country: Georgia
facility: SB Investigative Site
city: Tbilisi
country: Georgia
facility: SB Investigative Site
city: Düsseldorf
country: Germany
facility: SB Investigative Site
city: Giessen
country: Germany
facility: SB Investigative Site
city: Halle
country: Germany
facility: SB Investigative Site
city: Kassel
country: Germany
facility: SB Investigative Site
city: Moers
country: Germany
facility: SB Investigative Site
city: Neuss
country: Germany
facility: SB Investigative Site
city: Bangalore
country: India
facility: SB Investigative Site
city: Bhubaneshwar
country: India
facility: SB Investigative Site
city: Bhubaneswar
country: India
facility: SB Investigative Site
city: Erandwane
country: India
facility: SB Investigative Site
city: Hyderabad
country: India
facility: SB Investigative Site
city: Jaipur
country: India
facility: SB Investigative Site
city: Mumbai
country: India
facility: SB Investigative Site
city: Sūrat
country: India
facility: SB Investigative Site
city: Udaipur
country: India
facility: SB Investigative Site
city: Himeji
country: Japan
facility: SB Investigative Site
city: Iwakuni
country: Japan
facility: SB Investigative Site
city: Izumi
country: Japan
facility: SB Investigative Site
city: Kawachi-Nagano
country: Japan
facility: SB Investigative Site
city: Kobe
country: Japan
facility: SB Investigative Site
city: Kochi
country: Japan
facility: SB Investigative Site
city: Okayama
country: Japan
facility: SB Investigative Site
city: Sagamihara
country: Japan
facility: SB Investigative Site
city: Tachikawa
country: Japan
facility: SB Investigative Site
city: Takarazuka
country: Japan
facility: SB Investigative Site
city: Toyonaka
country: Japan
facility: SB Investigative Site
city: George Town
country: Malaysia
facility: SB Investigative Site
city: Johor Bahru
country: Malaysia
facility: SB Investigative Site
city: Kota Bharu
country: Malaysia
facility: SB Investigative Site
city: Kuantan
country: Malaysia
facility: SB Investigative Site
city: Lembah Pantai
country: Malaysia
facility: SB Investigative Site
city: Putrajaya
country: Malaysia
facility: SB Investigative Site
city: Aguascalientes
country: Mexico
facility: SB Investigative Site
city: Ciudad De México
country: Mexico
facility: SB Investigative Site
city: Guadalajara
country: Mexico
facility: SB Investigative Site
city: Davao City
country: Philippines
facility: SB Investigative Site
city: Makati City
country: Philippines
facility: SB Investigative Site
city: Manila
country: Philippines
facility: SB Investigative Site
city: Quezon City
country: Philippines
facility: SB Investigative Site
city: San Juan City
country: Philippines
facility: SB Investigative Site
city: Cluj-Napoca
country: Romania
facility: SB Investigative Site
city: Craiova
country: Romania
facility: SB Investigative Site
city: Iaşi
country: Romania
facility: SB Investigative Site
city: Oradea
country: Romania
facility: SB Investigative Site
city: Sibiu
country: Romania
facility: SB Investigative Site
city: Suceava
country: Romania
facility: SB Investigative Site
city: Timişoara
country: Romania
facility: SB Investigative Site
city: Târgu-Mureş
country: Romania
facility: SB Investigative Site
city: Belgrade
country: Serbia
facility: SB Investigative Site
city: Kragujevac
country: Serbia
facility: SB Investigative Site
city: Nis
country: Serbia
facility: SB Investigative Site
city: Sremska Kamenica
country: Serbia
facility: SB Investigative Site
city: Leganés
country: Spain
facility: SB Investigative Site
city: Madrid
country: Spain
facility: SB Investigative Site
city: Málaga
country: Spain
facility: SB Investigative Site
city: Ourense
country: Spain
facility: SB Investigative Site
city: Oviedo
country: Spain
facility: SB Investigative Site
city: Pamplona
country: Spain
facility: SB Investigative Site
city: Santiago De Compostela
country: Spain
facility: SB Investigative Site
city: Sevilla
country: Spain
facility: SB Investigative Site
city: Valencia
country: Spain
facility: SB Investigative Site
city: Bangkok Noi
country: Thailand
facility: SB Investigative Site
city: Bangkok
country: Thailand
facility: SB Investigative Site
city: Khon Kaen
country: Thailand
facility: SB Investigative Site
city: Adapazarı
country: Turkey
facility: SB Investigative Site
city: Ankara
country: Turkey
facility: SB Investigative Site
city: Balgat
country: Turkey
facility: SB Investigative Site
city: Bağcılar
country: Turkey
facility: SB Investigative Site
city: Cubuk
country: Turkey
facility: SB Investigative Site
city: Istanbul
country: Turkey
facility: SB Investigative Site
city: Izmit
country: Turkey
facility: SB Investigative Site
city: Kavaklıdere
country: Turkey
facility: SB Investigative Site
city: Konak
country: Turkey
facility: SB Investigative Site
city: Maltepe
country: Turkey
facility: SB Investigative Site
city: Seyhan
country: Turkey
facility: SB Investigative Site
city: Sivas
country: Turkey
facility: SB Investigative Site
Study officials:
References: