This study was designed to evaluate the safety and efficacy of trastuzumab deruxtecan in
HER2-mutated metastatic non-small cell lung cancer (NSCLC) participants who had disease
recurrence or progression during/after at least one regimen of prior anticancer therapy
(second line or later) that must have contained a platinum-based chemotherapy drug.
This randomized, two-arm, phase 2, multicenter study will evaluate the safety and efficacy of
5.4 mg/kg and 6.4 mg/kg trastuzumab deruxtecan administered every 3 weeks (Q3W) in
participants with HER2-mutated metastatic NSCLC. Each participant is expected to receive
approximately 14 months of trastuzumab deruxtecan treatment. The primary endpoint of the
study will be objective response rate (independent central review). Secondary endpoints will
include, but not limited to, disease control rate, duration of response, progression-free
survival, objective response rate (investigator), overall survival, and safety.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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