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.

Non-Small Cell Lung Cancer (NSCLC)

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.

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.