Overview

“A Randomized, Open-Label, Multi-Center, Phase 3 Study Evaluating the Efficacy and Safety of IBI363 Versus Docetaxel in Participants with Unresectable Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer with Disease Progression on or After Platinum-Based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy”

This study is testing whether a new medicine called IBI363 works better than the standard treatment docetaxel for people with advanced squamous non‑small cell lung cancer whose cancer has grown after chemotherapy and immunotherapy.

About 600 participants will be randomly assigned (like a coin flip) to receive either IBI363 or docetaxel. The study is open‑label, so you will know which treatment you are getting.

IBI363 is given as one small starting dose, followed by a higher dose every 3 weeks.

Docetaxel is given once every 3 weeks.

Your doctor may adjust your dose if needed.

You can continue treatment until your cancer gets worse, side effects become too hard, you choose to stop, or you reach 24 months of treatment.

You will have regular check‑ups and scans every 6–12 weeks to monitor your cancer. A team of independent experts will also review safety throughout the study.