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ACTIVE NOT RECRUITING Phase 2

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

NCT05280470 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • DRUG Ifinatamab Deruxtecan (I-DXd)

Study Locations (20)

Other

  • Jilin Cancer Hospital — Changchun
  • Hunan Cancer Hospital — Changsha
  • West China Hospital, Sichuan University — Chengdu
  • Guangdong Provincial People'S Hospital — Guangdong

Florida

  • The Cancer Specialists, Llc — Jacksonville
  • H. Lee Moffitt Cancer Center and Research Institute — Tampa

Michigan

  • Henry Ford Hospital — Detroit
  • Cancer and Hematology Centers of Western Michigan — Grand Rapids

New York

  • Memorial Sloan-Kettering Cancer Center (Mskcc) - New York — New York
  • Montefiore Medical Center Prime — The Bronx

Arkansas

  • Highlands Oncology Group — Springdale

Illinois

  • University of Chicago Medical Center — Chicago

Maryland

  • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center — Baltimore

Massachusetts

  • Dana-Faeber Cancer Institute — Boston

Trial Details

FieldValue
Enrollment Target 187 participants
Start Date 2022-03-09
Est. Completion 2026-12-15
Phase Phase 2

Sponsor

Daiichi Sankyo

157 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05280470

The ClinicalTrials.gov registry entry for NCT05280470 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 187 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Daiichi Sankyo, which has 157 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Extensive-stage Small-cell Lung Cancer appearing as the primary indexed condition, and to 1 intervention — of which Ifinatamab Deruxtecan (I-DXd) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05280470 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Other, Florida, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05280470 about?

NCT05280470 is a clinical study titled "Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC)". 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 chemo...

What is the current status of trial NCT05280470?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 187 participants. The study started on 2022-03-09. Estimated completion is 2026-12-15.

What conditions does trial NCT05280470 study?

This clinical trial studies the following conditions: Extensive-stage Small-cell Lung Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05280470?

The interventions under investigation include: Ifinatamab Deruxtecan (I-DXd) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05280470?

This trial is sponsored by Daiichi Sankyo, which has 157 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05280470 being conducted?

This trial has 20 study locations across Arkansas, Florida, Illinois, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial