🏛️ Verified NIH Record • Updated 2026-02-23

Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC) (NCT05280470)

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)

🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Daiichi Sankyo

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (22 items).

Location: Highlands Oncology Group — Springdale, Arkansas

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria: Participants who meet any of the following criteria will be disqualified from entering the study:
  • Prior treatment with orlotamab, enoblituzumab, or other B7-H3 targeted agents, including I-DXd.
  • Prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities.
  • Clinically active brain metastases, spinal cord compression or leptomeningeal carcinomatosis, defined as untreated or symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms.
  • Any of the following conditions within the past 6 months: cerebrovascular accident, transient ischemic attack, or another arterial thromboembolic event.
  • Clinically significant corneal disease.
  • Uncontrolled or significant cardiovascular disease.
  • History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required corticosteroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
  • Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses,
  • Chronic steroid treatment (dose of 10 mg daily or more prednisone equivalent), except for low-dose inhaled steroids (for asthma/COPD) or topical steroids (for mild skin conditions) or intra-articular steroid injections.
  • History of malignancy other than SCLC within the 3 years prior to enrollment, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, superficial gastrointestinal (GI) tract tumors and non-muscle invasive bladder cancer curatively resected by endoscopic surgery.
  • History of allogeneic bone marrow, stem cell, or solid organ transplant.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (58 Sites)

Showing the first 25 of 58 sites.

  • Highlands Oncology Group — Springdale, Arkansas
  • The Cancer Specialists, Llc — Jacksonville, Florida
  • H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida
  • University of Chicago Medical Center — Chicago, Illinois
  • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland
  • Dana-Faeber Cancer Institute — Boston, Massachusetts
  • Henry Ford Hospital — Detroit, Michigan
  • Cancer and Hematology Centers of Western Michigan — Grand Rapids, Michigan
  • Washington University School of Medicine — St Louis, Missouri
  • Hackensack Meridian Health-Southern Ocean Medical Center — Manahawkin, New Jersey
  • Memorial Sloan-Kettering Cancer Center (Mskcc) - New York — New York, New York
  • Montefiore Medical Center Prime — The Bronx, New York
  • Duke University Health System — Durham, North Carolina
  • Sarah Cannon (Tennessee Oncology - Nashville) — Nashville, Tennessee
  • Millennium Physicians Association, Llp — Houston, Texas
  • University of Washington Medical Center — Seattle, Washington
  • Jilin Cancer Hospital — Changchun,
  • Hunan Cancer Hospital — Changsha,
  • West China Hospital, Sichuan University — Chengdu,
  • Guangdong Provincial People'S Hospital — Guangdong,
  • Zhejiang Cancer Hospital — Hangzhou,
  • Linyi Cancer Hospital — Linyi,
  • Fudan University Shanghai Cancer Center — Shanghai,
  • Union Hospital of Tongji Medical College Huazhong University of Science and Technology — Wuhan,
  • Centre Hospitalier Intercommunal de Créteil — Créteil,

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Extensive-stage Small-cell Lung Cancer

Explore by condition: All Extensive-stage Small-cell Lung Cancer clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗