RecruitingPhase 1Phase 2NCT06362252

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

Conditions

Extensive-stage Small-cell Lung Cancer

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

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NCT06362252

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