Phase III Study of Osimertinib With or Without Datopotamab Deruxtecan for EGFRm Non-small Cell Lung Cancer
This study is testing two treatments for locally advanced or metastatic non-small cell lung cancer (NSCLC) that has a specific genetic change called EGFRm (Ex19del and/or L858R). You would receive either osimertinib alone, or osimertinib combined with Datopotamab Deruxtecan. Both are given as a first treatment for this type of cancer. Researchers want to see if the combination treatment is better at preventing the cancer from growing or spreading (progression-free survival). This study is for adults 18 and older with this specific type of NSCLC, and it aims to enroll 582 participants. The study will measure how long participants live without their cancer getting worse, with results expected about 3 years after the first participant joins.
- Study design
- This is a Phase III, open-label (meaning you and your doctors will know which treatment you are receiving), randomized study. It will compare two treatments in about 582 participants.
- What's involved
- You would receive treatment until your disease progresses or side effects become too much. You would have visits every 3 weeks during the treatment period.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome of the study, progression-free survival, is expected to be measured approximately 3 years after the first participant is randomized.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Phase III, Open-label Study of First-line Osimertinib With or Without Datopotamab Deruxtecan for EGFRm Locally Advanced or Metastatic Non-small Cell Lung Cancer
At a glance
Conditions
Where it's being run
167 sites across 36 statesWho to contact
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What this trial measures
- To demonstrate the superiority of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of Progression Free Survival (PFS) by BICR in all randomised participants.It is anticipated that it will be performed approximately 3 years after the first participant is randomised.
PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause (in the absence of progression).