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)
Start Date
7/22/2024
Completion Date
12/30/2026
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.
Detailed Description
This study consists of two parts and two cohorts: Part A (Phase 1b; Safety Run-in) and Part B (Phase 2; Dose Optimization), Cohort 1 (I-DXd in maintenance) and Cohort 2 (I-DXd in induction + maintenance). The primary objective of this study is to evaluate the safety and tolerability of I-DXd in combination with atezolizumab with or without carboplatin by assessing treatment-emergent adverse events (TEAEs) and other safety parameters which will inform optimal dose selection of I-DXd in the combination regimens (Dose Optimization Part B) of this study.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Ifinatamab deruxtecan
Atezolizumab
Carboplatin
Conditions
Locations
University of Alabama -Birmingham
Birmingham, Alabama 35233
United States
Mayo Clinic Arizona
Phoenix, Arizona 85054
United States
David Geffen School of Medicine
Los Angeles, California 90095
United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California 92663
United States
Mayo Clinic-Jacksonville
Jacksonville, Florida 32224
United States
Advent Health Orlando
Orlando, Florida 32804
United States
Moffitt Cancer Center
Tampa, Florida 33612
United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois 60611
United States
Henry Ford Hospital
Detroit, Michigan 48202
United States
Regents of the University of Minnesota
Minneapolis, Minnesota 55455
United States
Mayo Clinic
Rochester, Minnesota 55905
United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire 03766
United States
Astera Cancer Care
East Brunswick, New Jersey 08816
United States
John Theurer Cancer Center At Hackensack Umc
Hackensack, New Jersey 07601
United States
New York University Cancer Center - Laura and Isaac Perlmutter Cancer Center At Nyu Langone
Mineola, New York 11501
United States
NYU Langone Hospital - Long Island
Mineola, New York 11501
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10021
United States
Columbia University Hervert Irving Comprehensive Cancer Center
New York, New York 10032
United States
Montefiore Medical Center
New York, New York 10461
United States
Lancaster General Hospital - Ann B Barshinger Cancer Institute
Lancaster, Pennsylvania 17601
United States
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania 19104
United States
Thomas Jefferson University Hospital - Central
Philadelphia, Pennsylvania 19107
United States
Scri Oncology Partners
Nashville, Tennessee 37203
United States
Next Virginia
Fairfax, Virginia 22031
United States
Northwest Cancer Specialists, P.C.-Vancouver
Vancouver, Washington 98684
United States
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States
Hopital Albert Calmette - Chu Lille
Lille, 59037
France
Centre Léon Bérard
Lyon, 69008
France
Hôpital de la Timone
Marseille, 13005
France
Institut Curie - Site de Paris
Paris, 75005
France
Hopital Tenon
Paris, 75020
France
Chu Rennes - Hopital Pontchaillou
Rennes, 35000
France
CHU Nantes - Hôpital Guillaume et René Laënnec
Saint-Herblain, 44805
France
Hôpital Foch
Suresnes, 92151
France
Institut Gustave Roussy
Villejuif, 94805
France
NHO Himeji Medical Center
Himeji-shi, 670-8520
Japan
Kansai Medical University Hospital
Hirakata-shi, 573-1191
Japan
National Cancer Center Hospital East
Kashiwa, 277-8577
Japan
The Cancer Institute Hospital of Jfcr
Kōtoku, 135-8550
Japan
Social Welfare Organization Saiseikai Imperial Gift Foundation, Inc. Saiseikai Kumamoto Hospital
Kumamoto, 861-4193
Japan
Shizuoka Cancer Center
Nagaizumi-cho, 411-8777
Japan
Niigata Cancer Center Hospital
Niigata, 951-8566
Japan
Okayama University Hospital
Okayama, 700-8558
Japan
Kindai University Hospital
Ōsaka-sayama, 589-8511
Japan
Tokushima University Hospital
Tokushima, 770-8503
Japan
Fujita Health University Hospital
Toyoake-shi, 470-1192
Japan
Hospital Clinic de Barcelona
Barcelona, 08036
Spain
Hospital Universitari Vall D'Hebron
Barcelona, 8035
Spain
Ico Girona - Hospital Universitari de Girona Dr Josep Trueta
Girona, 17007
Spain
ICO l'Hospitalet - Hospital Duran i Reynals
L'Hospitalet de Llobregat, 08908
Spain
Hospital General Universitario Gregorio Marañon
Madrid, 28007
Spain
Hospital Universitario Ramon Y Cajal
Madrid, 28034
Spain
Hospital Universitario 12 de Octubre
Madrid, 28041
Spain
Next Madrid
Madrid, 28223
Spain
Hospital Regional Universitario de Malaga
Málaga, 29010
Spain
Hospital Universitario Virgen Macarena
Seville, 41009
Spain
Hospital Universitario Virgen Del Rocio
Seville, 41013
Spain
Hospital Alvaro Cunqueiro
Vigo, 36312
Spain