A PHASE 1B/2 MULTICENTER OPEN-LABEL STUDY OF IFINATAMAB DERUXTECAN (I-DXd) A B7-H3 ANTIBODY-DRUG CONJUGATE (ADC) IN COMBINATION WITH ATEZOLIZUMAB WITH OR WITHOUT CARBOPLATIN AS FIRST-LINE INDUCTION OR MAINTENANCE IN SUBJECTS WITH EXTENSIVE-STAGE SMALL CELL LUNG CANCER (ES-SCLC) (IDeate-Lung03)

Brief description of study

This global study is designed to test how safe and effective the drug I-DXd is when combined with atezolizumab, with or without carboplatin. The treatment will be used either as ongoing maintenance therapy or as part of a short initial treatment followed by maintenance. The study will take place at multiple locations in the United States, Europe, and Japan. It has two main parts: Part A focuses on checking safety, while Part B adjusts the doses to find the best amount to use. Patients must be able to perform normal daily activities and can join even if they have brain metastases that don’t cause symptoms. A type of radiation therapy called prophylactic cranial irradiation (PCI) is allowed if the patient’s cancer responds well to the treatment. The study will start by testing one group to see if the doses are safe before adding more groups and eventually randomizing patients. Previous studies suggest that combining I-DXd and atezolizumab should have manageable side effects. Researchers may add new treatment options to the study later if needed.


Clinical Study Identifier: s23-01369
ClinicalTrials.gov Identifier: NCT06362252
Principal Investigator: Vamsidhar Velcheti.
Other Investigators: Joshua K Sabari, Samantha VanMaanen, Elka R Travis, Salman Rafi Punekar, Jessica Wang, Elaine Shum, Carol M Lee, Laura Palazzolo, Jonathan B Kahn, Gabrielle Fridman, Danny Perlaza, Marissa Rybstein, David Mendoza, Natalia Cherkassky, James Newman, Jeffrey G Schneider, Sally Lau, Nitish Mehta, Kirby Rodriguez, Melissa L Martinez.


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