This study was designed to compare the efficacy and safety of I-DXd with treatment of physician's choice in participants with relapsed small cell lung cancer (SCLC).
Sign and date the informed consent form prior to the start of any study-specific qualification procedures.
Adults ≥18 years or the minimum legal adult age (whichever is greater) at the time the informed consent form is signed.
Has histologically or cytologically documented extensive-stage small cell lung cancer (ES-SCLC).
The participant must provide adequate baseline tumor samples with sufficient quantity and quality of tumor tissue content.
Has received prior treatment with orlotamab, enoblituzumab, or other B7 homologue 3 (B7-H3) targeted agents, including I-DXd.
Prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities.
Has received any of the comparators used in this study or any topoisomerase I inhibitor.
Has inadequate washout period before randomization as specified in the protocol.
Daiichi Sankyo
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator