Last updated 17 days ago
A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer
540 patients around the world
Available in Spain, Brazil, United States
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.
Daiichi Sankyo
10Research sites
540Patients around the world
This study is for people with
Lung cancer
Small cell lung carcinoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Participants must meet all the following criteria to be eligible for randomization into the study: 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 SCLC.The participant must provide adequate baseline tumor samples with sufficient quantity and quality of tumor tissue content.Has 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.Has at least 1 measurable lesion according to RECIST v1.1 as assessed by the investigator.Has documentation of radiological disease progression on or after the most recent systemic therapy.Has ECOG PS of ≤1.Subjects with untreated and asymptomatic brain metastases or subjects with treated brain metastases that are no longer symptomatic (ie, without neurologic signs or symptoms) and who require no treatment with steroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. Subjects must have a stable neurologic status for at least 2 weeks prior to the first dose of study drug.
- Has received prior treatment with orlotamab, enoblituzumab, or other humanized anti-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 disease.Has clinically significant corneal disease.Has history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required corticosteroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at Screening.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.
Sites
Hospital de Câncer de Barretos - Fundação PIO XII
Centro Pesquisas Oncologicas - CEPON
Catatina Pesquisa Clinica - Clinica de Neoplasias Litoral
Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul
Centro de Estudos e Pesquisas de Hematologia e Oncologia - CEPHO
Fundação Faculdade Regional de Medicina de São José do Rio Preto
Instituto do Câncer do Estado de São Paulo "Octavio Frias de Oliveira" - ICESP
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
Beneficência Portuguesa de São Paulo
AC Camargo Cancer Center
StudyIDeate-Lung02
SponsorDaiichi Sankyo
Conditions
Small cell lung carcinoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06203210
