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Active, not recruiting Phase 2 Interventional

Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC)

ClinicalTrials.gov ID: NCT05280470

Public ClinicalTrials.gov record NCT05280470. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 24, 2026, 8:18 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 2, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd), a B7-H3 Antibody Drug Conjugate (ADC), in Subjects With Pretreated Extensive-stage Small Cell Lung Cancer (ES-SCLC) (IDeate-Lung01)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This 2-part study intends to define the recommended Phase 2 dose of ifinatamab deruxtecan (I-DXd) based on the efficacy, safety, and pharmacokinetics (PK) results observed in participants with Extensive-stage Small Cell Lung Cancer (ES-SCLC) who received at least 1 prior line of platinum-based chemotherapy and a maximum of 3 prior lines of therapy (Part 1) and a minimum of two previous lines of systemic therapy (Part 2). This study will also investigate I-DXd anti-tumor activity in this population.

Study identification

NCT ID
NCT05280470
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 2
Lead sponsor
Daiichi Sankyo
Industry
Enrollment
187 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 8, 2022
Primary completion
Mar 2, 2025
Completion
Dec 14, 2026
Last update posted
Feb 24, 2026

2022 – 2026

United States locations

U.S. sites
16
U.S. states
13
U.S. cities
16
Facility City State ZIP Site status
Highlands Oncology Group Springdale Arkansas 72762 —
The Cancer Specialists, Llc Jacksonville Florida 32256 —
H. Lee Moffitt Cancer Center and Research Institute Tampa Florida 33612 —
University of Chicago Medical Center Chicago Illinois 60637 —
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center Baltimore Maryland 21287 —
Dana-Faeber Cancer Institute Boston Massachusetts 02215 —
Henry Ford Hospital Detroit Michigan 48202 —
Cancer and Hematology Centers of Western Michigan Grand Rapids Michigan 49503 —
Washington University School of Medicine St Louis Missouri 63110 —
Hackensack Meridian Health-Southern Ocean Medical Center Manahawkin New Jersey 08050 —
Memorial Sloan-Kettering Cancer Center (Mskcc) - New York New York New York 10065 —
Montefiore Medical Center Prime The Bronx New York 10461 —
Duke University Health System Durham North Carolina 27703 —
Sarah Cannon (Tennessee Oncology - Nashville) Nashville Tennessee 37203 —
Millennium Physicians Association, Llp Houston Texas 77090 —
University of Washington Medical Center Seattle Washington 98195 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 42 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05280470, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 24, 2026 · Synced Sep 24, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05280470 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →