A Phase 3, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd), a B7-H3 Antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice (TPC) in Subjects With Relapsed Small Cell Lung Cancer (SCLC) (IDeate-Lung02)
A Phase 3, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd), a B7-H3 Antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice (TPC) in Subjects With Relapsed Small Cell Lung Cancer (SCLC) (IDeate-Lung02)
This study is 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).
The primary objective of this study is to assess whether treatment with I-DXd 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.
Inclusion Criteria
Participants must meet all the following criteria to be eligible for randomization into the study:
Exclusion Criteria
Participants who meet any of the following criteria will be disqualified from entering the study:
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.
Has any of the following conditions within the past 6 months: cerebrovascular accident, transient ischemic attack, or another arterial thromboembolic event.
Has uncontrolled or significant cardiovascular (CV) disease.
Has clinically significant corneal disease.
All of the following indicators of interstitial lung disease (ILD)/pneumonitis are excluded:
Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses, including, but not limited to, any underlying pulmonary disorder and potential pulmonary involvement caused by any autoimmune, connective tissue, or inflammatory disorders, prior pneumonectomy, or requirement for supplemental oxygen.
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Springdale, Arkansas 72762, United States
Miami, Florida 33136, United States
Tampa, Florida 33612, United States
Baltimore, Maryland 21201, United States
St Louis, Missouri 63128, United States
New York, New York 10016, United States
New York, New York 10016, United States
Santo André, 09060-650, Brazil
São José do Rio Preto, 15090-000, Brazil
São Paulo, 01246-000, Brazil
Haerbin, 150081, China
Hangzhou, 310003, China
Wuhan, 430022, China
Wuhan, 430030, China
Brescia, 25124, Italy
Catania, 95123, Italy
Monza, 20900, Italy
Naples, 80131, Italy
Hirakata-shi, 573-1191, Japan
Osaka-Sakai, 590-0197, Japan
Lisbon, 1769-001, Portugal
Cluj-Napoca, 400015, Romania
Las Palmas de Gran Canaria, 35016, Spain
Ankara, 06105, Turkey (Türkiye)
Istanbul, 34098, Turkey (Türkiye)