A Study of Ifinatamab Deruxtecan versus Treatment of Physician's Choice in Subjects with Relapsed Small Cell Lung Cancer (IDeate-Lung02)

The purpose of this study is to learn more about an investigational drug called Ifinatamab Deruxtecan or I-DXd. "Investigational" means that it has not beed approved by the U.S. Food and Drug Administration (FDA). The investigational drug, I-DXd, is being developed by the Sponsor, Daiichi Sankyo.

I-DXd is a type of drug called an antibody drug conjugate, which is made up of 2 parts: an antibody and an anticancer drug. "the antibody part blinds to a protein commonly found on tumor cells called humanized anti‑B7 homologue 3, while the drug is released to attack cancer cells. By using an antibody, the drug should reach the tumor directly while sparing healthy cells. This should decrease the side effects caused by chemotherapy and make sure that tumor cells are effectively killed.

I-DXd is an experimental drug to be used only in research. It is not yet approved in any country. It is not approved by United States Food and Drug Administration (FDA) either.

In another study, I-DXd was evaluated to figure out which dose level was optimal against the participants disease. In this study, I-DXd is being compared to the standard treatment of the participants disease, to see differences in side effects and efficacy. The standard treatments for the partcipants disease that will be used in this study are amrubicin, lurbinectedin, and topotecan. Collectively, these standard treatments are called the “treatment of physician’s choice” (TPC), as compared to I-DXd.

Amrubicin, lurbinectedin, and topotecan are approved for the treatment of patients with SCLC who have previously received standard chemotherapy in various countries worldwide. In USA lurbinectedin and topotecan are approved and can be used in this study as TPC.

The primary objective of this study is to assess whether treatment with I-DXd improves objective response rate (ORR) and prolongs overall survival (OS) compared with treatment of physician's choice among participants with relapsed SCLC.

The secondary objectives of the study are to further evaluate the efficacy/safety of I-DXd, health economics and outcome research measures (including patient reported outcomes), immunogenicity of I-DXd, B7-H3 protein expression, and characterize the pharmacokinetics of I-DXd.

In order to participate you must meet the following criteria:

• Have histologically or cytologically documented extensive-stage small cell lung cancer (ES-SCLC).
• Provide adequate baseline tumor samples with sufficient quantity and quality of tumor tissue content.
• Have received prior therapy with only one prior platinum-based line as systemic therapy for SCLC with at least 2 cycles of therapy and a chemotherapy free-interval of ≥30 days.
• Have at least 1 measurable lesion according to RECIST v1.1 as assessed by the investigator.

You will be excluded from the study if any of the following criteria apply to you:

• Have received prior treatment with orlotamab, enoblituzumab, or other B7 homologue 3 (B7-H3) targeted agents, including I-DXd.
• Have had prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities.
• Have received any of the comparators used in this study or any topoisomerase I inhibitor.
• Have inadequate washout period before randomization as specified in the protocol.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.