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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?
Non-Small Cell Lung Cancer (NSCLC)
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.
Age Group
Adults
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
Medical Oncologist
Protocol Number
IRB:
PRO00118523
NCT:
NCT06907615
Phase
Phase
II
ClinicalTrials.gov
View on ClinicalTrials.gov
Enrollment Status
Open for Enrollment Soon