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Henlius HLX43 for previously treated Advanced Non-Small Cell Lung Cancer - Clinical Trial

What is the Purpose of this Study?

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.

What is the Condition Being Studied?

Cáncer de pulmón de células no pequeñas (CPCNP)

Who Can Participate in the Study?

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

What is Involved?

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.

Study Details

Full Title

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)

Principal Investigator