Non-small Cell Lung Cancer Stage IV Clinical Trial
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
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.
Status | Recruiting |
Enrollment | 616 |
Est. completion date | March 2027 |
Est. primary completion date | September 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Georgia | SB Investigative Site | Batumi | |
Georgia | SB Investigative Site | Tbilisi | |
Germany | SB Investigative Site | Hessen | |
Germany | SB Investigative Site | North Rhine-Westphalia | |
Germany | SB Investigative Site | North Rhine-Westphalia | |
Germany | SB Investigative Site | Saxony-Anhalt | |
India | SB Investigative Site | Jaipur | |
India | SB Investigative Site | Karnataka | |
India | SB Investigative Site | Odisha | |
India | SB Investigative Site | Rajasthan | |
India | SB Investigative Site | Surat | |
Japan | SB Investigative Site | Hyogo | |
Japan | SB Investigative Site | Kanagawa | |
Japan | SB Investigative Site | Kochi | |
Japan | SB Investigative Site | Okayama | |
Japan | SB Investigative Site | Osaka | |
Japan | SB Investigative Site | Tokyo | |
Japan | SB Investigative Site | Yamaguchi | |
Malaysia | SB Investigative Site | Johor | |
Malaysia | SB Investigative Site | Kelantan | |
Malaysia | SB Investigative Site | Pulau Pinang | |
Malaysia | SB Investigative Site | Wilayah Persekutuan Putrajaya | |
Romania | SB Investigative Site | Bihor | |
Romania | SB Investigative Site | Cluj-Napoca | |
Romania | SB Investigative Site | Craiova | |
Romania | SB Investigative Site | Iasi | |
Romania | SB Investigative Site | Mures | |
Romania | SB Investigative Site | Sibiu | |
Romania | SB Investigative Site | Suceava | |
Romania | SB Investigative Site | Timis | |
Spain | SB Investigative Site | A Coruña | |
Spain | SB Investigative Site | Madrid | |
Spain | SB Investigative Site | Ourense | |
Spain | SB Investigative Site | Valencia |
Lead Sponsor | Collaborator |
---|---|
Samsung Bioepis Co., Ltd. |
Georgia, Germany, India, Japan, Malaysia, Romania, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | At Week 24 |
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