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.
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 Spain