Summary
Telisotuzumab adizutecan is an investigational drug called an antibody-drug conjugate being developed for the treatment of non-small cell lung cancer (NSCLC). Osimertinib (Osi) is a targeted drug called a TKI inhibitor and is currently approved for the treatment of NSCLC.
This study will be divided into two stages.
In Stage 1, during dose escalation participants will receive increasing intravenous (IV) doses of telisotuzumab adizutecan with oral Osi tablets. Following this, during dose optimisation, participants will be randomly allocated to one of four treatment arms. One arm will receive treatment with Osi oral tablets alone, and three arms will receive 1 of 3 optimised doses of telisotuzumab adizutecan with Osi.
In Stage 2, participants will either receive the optimal dose of IV telisotuzumab adizutecan as determined in the previous stage with oral Osi tablet, or standard of care treatment with Osi oral tablets alone.
The study will run for a duration of approximately 76 months. There may be a higher treatment burden participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.