A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer
Recruiting · NCT06203210 · Interventional (participants receive a specific treatment) · Lead sponsor: Daiichi Sankyo
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Participants must meet all the following criteria to be eligible for randomization into the study:
- Sign and date the informed consent form (ICF) prior to the start of any study-specific qualification procedures.
- Adults greater than or equal to (≥)18 years or the minimum legal adult age (whichever is greater) at the time the ICF 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 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 \[CTFI\] (duration from stop date of the platinum agent in 1L therapy to radiological PD) 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 less than or equal to (≤)1 within 7 days prior to Cycle 1 Day 1 (C1D1).
- Participants with brain metastasis/leptomeningeal disease are eligible if protocol specified criteria are met.
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:
- Any history of ILD/pneumonitis irrespective of steroid use, except for a history of radiation pneumonitis that did not require steroids.
- Current diagnosis of ILD.
- Clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out. Radiographic findings may include presence of lung parenchymal fibrosis, combined fibrosis and emphysema (CPFE), and/or interstitial lung abnormalities such as reticular opacities, traction bronchiectasis, honeycombing, or extensive ground glass opacities. Screening computed tomography (CT) scans must be submitted for independent central radiology review and results before randomization.
- 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.
Where it is running
60 locations listed across 18 US states.
- Highlands Oncology Group - Springdale, Arkansas, United States
- Clinical Research Providence Medical Foundation - Fullerton, California, United States
- UCLA Hematology-Oncology - Los Angeles, California, United States
- UCSF Mission Bay Mission Hall - San Francisco, California, United States
- University of Miami Hospital and Clinics Sylvester Comprehensive Cancer Center - Miami, Florida, United States
- AdventHealth Orlando, Cancer Institute - Orlando, Florida, United States
- H. Lee Moffitt Cancer Center and Research Institute, Inc - Tampa, Florida, United States
- Rush MD Anderson Cancer Center - Chicago, Illinois, United States
- Baptist Health Lexington - Lexington, Kentucky, United States
- University of Maryland Greenebaum Comprehensive Cancer Center - Baltimore, Maryland, United States
- John Hopkins School of Medicine - Baltimore, Maryland, United States
- Dana-Farber Cancer Institute - Boston, Massachusetts, United States
- Henry Ford Health System - Detroit, Michigan, United States
- Mercy Clinic Oncology and Hematology Sindelar Cancer Center - St Louis, Missouri, United States
- University of Nebraska Medical Center - Omaha, Nebraska, United States
- Dartmouth-Hitchcock Medical Center - Lebanon, New Hampshire, United States
- Astera Cancer Care - East Brunswick, New Jersey, United States
- Hackensack Meridian Health Jsumc - Neptune City, New Jersey, United States
- Clinical Research Alliance, Inc - Lake Success, New York, United States
- Laura and Isaac Perlmutter Cancer Center at NYU Langone Health Long Island - New York, New York, United States
- New York University Cancer Center - Laura and Isaac - New York, New York, United States
- Montefiore Medical Center Prime - The Bronx, New York, United States
- Cleveland Clinic Mercy Hospital - Canton, Ohio, United States
- Oncology/Hematology Care Clinical Trials, Llc - Cincinnati, Ohio, United States
- Providence Portland Medical Center - Portland, Oregon, United States
- THE WEST CLINIC, PLLC dba West Cancer Center - Germantown, Tennessee, United States
- Houston Methodist Cancer Center - Houston, Texas, United States
- University of Texas Md Anderson Cancer Center - Houston, Texas, United States
- Texas Oncology, P.A. - Tyler - Tyler, Texas, United States
- Medical College of Wisconsin - Milwaukee, Wisconsin, United States
- Jeroen Bosch Ziekenhuis - 's-Hertogenbosch, Netherlands
- Netherlands Cancer Institute - Amsterdam, Netherlands
- Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital - Ankara, Turkey (Türkiye)
- Ankara Bilkent City Hospital - Ankara, Turkey (Türkiye)
- 'Henry Dynant' Hospital Center - Athens, Greece
- General Hospital of Athens of Chest Diseases 'Sotiria' - Athens, Greece
- General Hospital of Athens Alexandra - Athens, Greece
- Institut Sainte Catherine - Avignon, France
- Ballarat Base Hospital - Ballarat, Australia
- Hospital Clinic de Barcelona - Barcelona, Spain
- Hospital de La Santa Creu I Sant Pau - Barcelona, Spain
- Hospital Universitari Vall D'Hebron - Barcelona, Spain
- Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari - Bari, Italy
- Departmento de Pesquisa Clinica- Hospital de Amor de Barretos - Barretos, Brazil
- Flinders Medical Centre (Fmc) - Bedford Park, Australia
- China-Japan Friendship Hospital - Beijing, China
- Beijing Cancer Hospital - Beijing, China
- Beijing Chest Hospital,Capital Medical University - Beijing, China
- Humanitas Gavazzeni - Bergamo, Italy
- Evangelische Lungenklinik Berlin - Berlin, Germany
- Inselspital - Universitaetsspital Bern - Bern, Switzerland
- Chu Bordeaux - Bordeaux, France
- William Osler Health System - Brampton Civic Hospital - Brampton, Canada
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia (Presidio Spedali Civili) - Brescia, Italy
- Cliniques Universitaires Saint-Luc - Brussels, Belgium
- S.C Radiotherapy Center Cluj S.R.L - Bucharest, Romania
- Semmelweis Egyetem - Budapest, Hungary
- Orszagos Koranyi Pulmonologiai Intezet - Budapest, Hungary
- Orszagos Onkologiai Intezet - Budapest, Hungary
- Centrum Onkologii Im. Prof. F. Lukaszczyka W Bydgoszczy - Bydgoszcz, Poland
Showing 60 of 229 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →