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.
Who Can Participate?
Eligibility
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
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
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.
Locations
Duke University Hospital
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
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
Laura
Alder
Protocol Number
PRO00118523
NCT ID
NCT06907615
Phase
II
Enrollment Status
Pending Open to Enrollment