Summary
This study is evaluating an antibody-drug conjugate called sacituzumab tirumotecan to see whether it is more effective than other treatments. Sacituzumab tirumotecan consists of a monoclonal antibody that targets the TROP2 protein on tumour cells, and delivers a toxin directly to these cells.
This study has two phases: a safety run-in and a Phase 3 portion.
In the Safety Run-In phase, the safety and efficacy of sacituzumab tirumotecan, will be evaluated at the dose level to be evaluated in the next phase. In the Phase 3 portion, eligible participants will be randomly allocated (by chance) to one of two treatment arms.
In the Experimental Arm, participants will receive sacituzumab tirumotecan once every 2 weeks via intravenous (IV) infusion.
In the Active Comparator Arm, participants will receive treatment of the physician's choice, all to be administered via IV infusion. This may be:
- Pemetrexed chemotherapy every 3 weeks,
- An antibody-drug conjugate called Tisotumab vedotin every 3 weeks,
- Topotecan chemotherapy on days 1, 2, 3, 4 and 5 of every 3-week cycle,
- Vinorelbine chemotherapy on days 1 and 8 of every 3-week cycle,
- Gemcitabine chemotherapy on days 1 and 8 of every 3-week cycle, or
- Irinotecan chemotherapy on Days 1, 8, 15 and 22 of every 6 week cycle.