ACTIVE_NOT_RECRUITING

A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer

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 was 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).

Official Title

A Phase 3, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd), a B7-H3 Antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice (TPC) in Subjects With Relapsed Small Cell Lung Cancer (SCLC) (IDeate-Lung02)

Quick Facts

Study Start:2024-05-21
Study Completion:2029-02-22
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06203210

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

Principal Investigator

Global Clinical Director
STUDY_DIRECTOR
Daiichi Sankyo

Study Locations (Sites)

Highlands Oncology Group
Springdale, Arkansas, 72762
United States
Clinical Research Providence Medical Foundation
Fullerton, California, 92835
United States
UCLA Hematology-Oncology
Los Angeles, California, 90095
United States
UCSF Mission Bay Mission Hall
San Francisco, California, 94115
United States
University of Miami Hospital and Clinics Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
United States
AdventHealth Orlando, Cancer Institute
Orlando, Florida, 32804
United States
H. Lee Moffitt Cancer Center and Research Institute, Inc
Tampa, Florida, 33612
United States
Rush University Medical Center
Chicago, Illinois, 60612
United States
Baptist Health Lexington
Lexington, Kentucky, 40503
United States
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201
United States
John Hopkins School of Medicine
Baltimore, Maryland, 21287
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02216
United States
Henry Ford Health System
Detroit, Michigan, 48202
United States
Mercy Clinic Oncology and Hematology Sindelar Cancer Center
St Louis, Missouri, 63128
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-6811
United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766
United States
Astera Cancer Care
East Brunswick, New Jersey, 08816
United States
Meridian Health Systems
Neptune City, New Jersey, 07753
United States
Clinical Research Alliance, Inc
Lake Success, New York, 11042
United States
New York University Cancer Center - Laura and Isaac
New York, New York, 10016
United States
Montefiore Medical Center Prime
The Bronx, New York, 10461
United States
Cleveland Clinic Mercy Hospital
Canton, Ohio, 44708
United States
Oncology/Hematology Care Clinical Trials, Llc
Cincinnati, Ohio, 45236
United States
Providence Portland Medical Center
Portland, Oregon, 97213
United States
THE WEST CLINIC, PLLC dba West Cancer Center
Germantown, Tennessee, 38138
United States
Houston Methodist Cancer Center
Houston, Texas, 77030
United States
University of Texas Md Anderson Cancer Center
Houston, Texas, 77030
United States
Texas Oncology, P.A. - Tyler
Tyler, Texas, 75702
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Daiichi Sankyo

  • Global Clinical Director, 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 Date2024-05-21
Study Completion Date2029-02-22

Study Record Updates

Study Start Date2024-05-21
Study Completion Date2029-02-22

Terms related to this study

Keywords Provided by Researchers

  • Small cell lung cancer
  • Ifinatamab deruxtecan
  • I-DXd

Additional Relevant MeSH Terms

  • Small Cell Lung Cancer