A Study of SKB264 (MK-2870; Sac-TMT) for the Treatment of Participants With Advanced or Metastatic Non-small Cell Lung Cancer (SKB264-II-04) (MK-2870-003)
Condition(s) studied
Investigational drug(s) / intervention(s)
SKB264: intravenous (IV) infusion (Q2W or Q3W)
Pembrolizumab: intravenous (IV) infusion (400mg, Q6W)
Carboplatin: intravenous (IV) infusion (AUC5, Q3W)
Osimertinib: 80mg, QD
Study summary
The purpose of this study is to evaluate the safety, tolerability and objective response rate of SKB264 as combination with therapy in subjects with advanced or metastatic non-small cell lung cancer.
Eligibility
Primary outcome measure(s)
- Safety and tolerability — From subject sign the informed consent form (ICF) to 30 days after the last dose of study treatment, up to approximately 36 months
Dose-limiting toxicity (DLT); Incidence and severity of adverse events (AEs); Discontinuation of study treatment due to AEs - ORR — The proportion of subjects with a confirmed complete response (CR) or partial response (PR), up to approximately 36 months
Objective response rate (ORR) per RECIST v1.1
Trial sites (50)
| Facility | City | Region | Status |
|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | |
| Chongqing University Cancer Hospital (Chongqing Cancer Hospital) | Chongqing | Chongqing Municipality | |
| Fujian Cancer Hospital | Fuzhou | Fujian | |
| Sun Yat-Sen University Cancer Center | Guangzhou | Guangdong | |
| Sun Yatsen University Cancer Center Huangpu Hos | Guangzhou | Guangdong | |
| Guangxi Cancer Hospital/ Guangxi Medical University Cancer Hospital | Nanning | Guangxi | |
| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | |
| The First Affiliated Hospital of Zhengzhou University(Heyi Compus) | Zhengzhou | Henan | |
| Henan Cancer Hospital,Affiliated Cancer Hospital of Zhengzhou University | Zhengzhou | Henan | |
| Zhongnan Hospital of Wuhan University | Wuhan | Hubei | |
| Hubei Cancer Hospital | Wuhan | Hubei | |
| Hunan Cancer Hospital | Changsha | Hunan | |
| The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | |
| Jilin Cancer Hospital | Changchun | Jilin | |
| The First Hospital of Jilin University | Changchun | Jilin | |
| The First Hospital of Chinese Medical University(Heping Compus) | Shenyang | Liaoning | |
| The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi | |
| Shandong Cancer Hospital and Institute | Jinan | Shandong | |
| Shanghai Chest Hospital | Shanghai | Shanghai Municipality | |
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | |
| Shanxi Provincial Cancer Hospital | Taiyuan | Shanxi | |
| Sichuan Cancer Hospital | Chengdu | Sichuan | |
| West China Hospital of Sichuan University | Chengdu | Sichuan | |
| Chengdu Fifth People's Hospital | Chengdu | Sichuan | |
| Tianjin Medical University Cancer Institute & Hospital | Tianjin | Tianjin Municipality | |
| The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | |
| ISR-GEO Med Res Clin Healthycore | Tbilisi | Georgia | |
| LLC "Todua Clinic" | Tbilisi | Georgia | |
| Ltd New Hospitals | Tbilisi | Georgia | |
| Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca | Cluj-Napoca | Cluj | |
| Centrul de Oncologie Sf. Nectarie | Craiova | Dolj | |
| The Catholic University of Korea, St. Vincent's Hospital | Suwon | Gyeonggido | |
| Chungbuk National University Hospital | Cheongju-si | North Chungcheong | |
| Samsung Medical Center | Seoul | Seoul Teugbyeolsi | |
| Inje University Haeundae Paik Hospital | Busan | South Korea | |
| Severance Hospital, Yonsei University Health System | Seoul | South Korea | |
| Hospital Universitario Puerta De Hierro De Majadahonda | Majadahonda | Madrid | |
| Hospital Universitario QuirónSalud Madrid | Pozuelo de Alarcón | Madrid | |
| Micancer Center S.L.P. | Barcelona | Spain |
+ 10 more sites — see the full list on the official registry below.
More Klus Pharma Inc. trials in South Korea
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05816252 on ClinicalTrials.gov ↗ ← All trials in South Korea