A Study of I-DXd in Combination With Atezolizumab With or Without Carboplatin as First-Line Induction or Maintenance in Subjects With Extensive Stage-Small Cell Lung Cancer (IDeate-Lung03)
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)
Sponsor
Daiichi Sankyo
Enrollment
123 participants
Start Date
Jul 22, 2024
Study Type
INTERVENTIONAL
Summary
This study is designed to evaluate the safety and efficacy of ifinatamab deruxtecan (I-DXd) in combination with immune checkpoint inhibitor (ICI) atezolizumab with or without carboplatin in participants with extensive stage-small cell lung cancer (ES-SCLC) in the first-line (1L) setting.
Eligibility
Min Age: 18 Years
Plain Language Summary
Simplified for easier understanding
This trial (IDeate-Lung03) is testing a drug called I-DXd (ifinatamab deruxtecan — an antibody that delivers chemotherapy directly to cancer cells) combined with atezolizumab (immunotherapy), with or without carboplatin (chemotherapy), for extensive-stage small cell lung cancer (ES-SCLC). ES-SCLC is an aggressive form of lung cancer that has spread widely. The trial has two groups: one for patients who have completed first-line treatment and are holding steady, and one for patients who have not yet received any treatment.
**You may be eligible if...**
- You are 18 or older
- You have been confirmed by biopsy to have extensive-stage small cell lung cancer (ES-SCLC)
- Cohort 1: You have completed 4 cycles of first-line carboplatin + etoposide + atezolizumab and your cancer has responded or stabilized
- Cohort 2: You have not yet received any treatment for ES-SCLC and have at least one measurable lesion and a tumor available for biopsy
- You are in good general health (ECOG 0–1)
- You have adequate organ function
**You may NOT be eligible if...**
- You have active brain metastases that are symptomatic or untreated
- You have a history of serious lung disease (e.g., interstitial lung disease or pneumonitis)
- You have active autoimmune disease requiring treatment
- You are pregnant or breastfeeding
Talk to your doctor to see if this trial is right for you.
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
DRUGIfinatamab deruxtecan
Intravenous administration
DRUGAtezolizumab
Intravenous administration
DRUGCarboplatin
Intravenous administration
Locations(58)
University of Alabama -Birmingham
Birmingham, Alabama, United States
Mayo Clinic Arizona
Phoenix, Arizona, United States
David Geffen School of Medicine
Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Mayo Clinic-Jacksonville
Jacksonville, Florida, United States
Advent Health Orlando
Orlando, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, United States
Henry Ford Hospital
Detroit, Michigan, United States
Regents of the University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Astera Cancer Care
East Brunswick, New Jersey, United States
John Theurer Cancer Center At Hackensack Umc
Hackensack, New Jersey, United States
New York University Cancer Center - Laura and Isaac Perlmutter Cancer Center At Nyu Langone
Mineola, New York, United States
NYU Langone Hospital - Long Island
Mineola, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Columbia University Hervert Irving Comprehensive Cancer Center
New York, New York, United States
Montefiore Medical Center
New York, New York, United States
Lancaster General Hospital - Ann B Barshinger Cancer Institute
Lancaster, Pennsylvania, United States
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital - Central
Philadelphia, Pennsylvania, United States
Scri Oncology Partners
Nashville, Tennessee, United States
Next Virginia
Fairfax, Virginia, United States
Northwest Cancer Specialists, P.C.-Vancouver
Vancouver, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Hopital Albert Calmette - Chu Lille
Lille, France
Centre Léon Bérard
Lyon, France
Hôpital de la Timone
Marseille, France
Institut Curie - Site de Paris
Paris, France
Hopital Tenon
Paris, France
Chu Rennes - Hopital Pontchaillou
Rennes, France
CHU Nantes - Hôpital Guillaume et René Laënnec
Saint-Herblain, France
Hôpital Foch
Suresnes, France
Institut Gustave Roussy
Villejuif, France
NHO Himeji Medical Center
Himeji-shi, Japan
Kansai Medical University Hospital
Hirakata-shi, Japan
National Cancer Center Hospital East
Kashiwa, Japan
The Cancer Institute Hospital of Jfcr
Kōtoku, Japan
Social Welfare Organization Saiseikai Imperial Gift Foundation, Inc. Saiseikai Kumamoto Hospital
Kumamoto, Japan
Shizuoka Cancer Center
Nagaizumi-cho, Japan
Niigata Cancer Center Hospital
Niigata, Japan
Okayama University Hospital
Okayama, Japan
Kindai University Hospital
Ōsaka-sayama, Japan
Tokushima University Hospital
Tokushima, Japan
Fujita Health University Hospital
Toyoake-shi, Japan
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital Universitari Vall D'Hebron
Barcelona, Spain
Ico Girona - Hospital Universitari de Girona Dr Josep Trueta
Girona, Spain
ICO l'Hospitalet - Hospital Duran i Reynals
L'Hospitalet de Llobregat, Spain
Hospital General Universitario Gregorio Marañon
Madrid, Spain
Hospital Universitario Ramon Y Cajal
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Next Madrid
Madrid, Spain
Hospital Regional Universitario de Malaga
Málaga, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Hospital Universitario Virgen Del Rocio
Seville, Spain
Hospital Alvaro Cunqueiro
Vigo, Spain
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.