RECRUITING

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)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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)

Quick Facts

Study Start:2024-07-22
Study Completion:2026-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06362252

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

(US) Daiichi Sankyo Contact for Clinical Trial Information
CONTACT
9089926400
CTRinfo_us@daiichisankyo.com
(Asia) Daiichi Sankyo Contact for Clinical Trial Information
CONTACT
+81-3-6225-1111 (M-F 9-5 JST
dsclinicaltrial@daiichisankyo.co.jp

Principal Investigator

Global Clinical Leader
STUDY_DIRECTOR
Daiichi Sankyo

Study Locations (Sites)

University of Alabama -Birmingham
Birmingham, Alabama, 35233
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
Adventhealth Orlando
Orlando, Florida, 32804
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
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
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
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

Collaborators and Investigators

Sponsor: Daiichi Sankyo

  • Global Clinical Leader, STUDY_DIRECTOR, Daiichi Sankyo

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-22
Study Completion Date2026-12-30

Study Record Updates

Study Start Date2024-07-22
Study Completion Date2026-12-30

Terms related to this study

Keywords Provided by Researchers

  • Extensive stage-small cell lung cancer (ES-SCLC)
  • Ifinatamab deruxtecan
  • I-DXd

Additional Relevant MeSH Terms

  • Extensive Stage-small Cell Lung Cancer