Henlius HLX43 for previously treated Advanced Non-Small Cell Lung Cancer - Clinical Trial
¿Cuál es el Propósito de este estudio?
We are doing this study to find out if an experimental drug called HLX43 (the study drug) is a safe and beneficial option for people with non-small cell lung cancer (NSCLC) that did not respond favorably to standard treatments.
¿Cuál es la Condición que se está estudiando?
Cáncer de pulmón de células no pequeñas (CPCNP)
¿Quién puede participar en el Estudio?
Adults ages 18+ who:
- Are diagnosed with NSCLC
- Have locally advanced (stage IIIB/IIIC) or metastatic (stage IV) disease that is not suitable for radical treatment (complete surgical resection, concurrent/sequential radio-chemotherapy)
- Have failed to improve after 1 or more lines of standard treatment that included an anti-PD-(L)1 antibody and platinum-based chemotherapy
For more information, contact the study team at alicia.wilkerson@duke.edu.
Grupo etario
Adultos
¿Qué Implica?
This study consists of two parts:
- Part A: This part of the study is the dose exploration phase. You will get a random assignment (like a coin flip) to get the study drug at either a dose of 2.0 mg/kg or 2.5 mg/kg. You will get a dose of the study drug every 3 weeks.
- Part A: This part of the study will happen after Part A ends. If you are in this part of the study, you will get the dose of the study drug from Part A that seems to work best.
If you choose to join the study, whether you participate in Part A or Part B will depend on when you take part.
Detalles del Estudio
Título Completo
An Open-label, Multi-center, Global Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Subjects with Advanced Non-small Cell Lung Cancer (NSCLC)
Investigador Principal
Laura Alder, MD
Especialista en oncología médica
Número de Protocolo
IRB:
PRO00118523
NCT:
NCT06907615
Fase
Phase
II
ClinicalTrials.gov
Ver en ClinicalTrials.gov
Estado de inscripción
Abierto para inscripción