Lung Cancer Trials Ask AI to find trials
Active Not RecruitingPhase 2NCT05280470
Official study title

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

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.

Ask AI to explain this study
Start here

Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedIfinatamab Deruxtecan (I-DXd)

The study team can explain what participation involves.

Who it may be forSmall cell lung cancer (SCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Feb 25, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Phase 2

Interventional

Where is it offered?58 U.S. locations

Locations may change over time.

Who runs it?Daiichi Sankyo

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Daiichi Sankyo
Interventions being studied
Drug: Ifinatamab Deruxtecan (I-DXd)
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Small cell lung cancer (SCLC)→
Treatment approach
Chemotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Participants must meet all the following criteria to be eligible for enrollment into the study:
  • Sign and date the informed consent form (ICF) prior to the start of any study-specific qualification procedures.
  • Participant must have at least one lesion, not previously irradiated, amenable to core biopsy.
  • Male or female subjects aged ≥18 years (follow local regulatory requirements if the legal age of consent for study participation is \>18 years old).
  • Histologically or cytologically documented ES-SCLC.
  • At least one measurable lesion according to RECIST v1.1 as assessed by the investigator.
  • Prior therapy with at least one platinum-based line as systemic therapy for extensive-stage disease with at least two cycles of therapy (except in the case of early objective PD) and beginning with protocol version 3.0, a minimum of two previous lines of systemic therapy.
  • Documentation of radiological disease progression on or after most recent systemic therapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
Reasons someone may not be able to joinExclusion 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.
  • Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE V5.0), Grade ≤1 or baseline.
  • History of hypersensitivity to the drug substances, inactive ingredients in the drug product or severe hypersensitivity reactions to other monoclonal antibodies.
  • Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection.
  • Has active or uncontrolled hepatitis B or C infection.
  • Active, known, or suspected autoimmune disease.
  • Any evidence of severe or uncontrolled systemic diseases (including active bleeding diatheses, psychiatric illness/social situations, substance abuse).
  • Has received a live vaccine within 30 days prior to the first dose of study drug.
  • Female who is pregnant or breast-feeding or intends to become pregnant during the study.
  • Prior or ongoing clinically relevant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the investigator's opinion, could affect the safety of the participant.
  • Known human immunodeficiency virus (HIV) infection that is not well controlled.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Highlands Oncology GroupSpringdale, Arkansas
  • The Cancer Specialists, LlcJacksonville, Florida
  • H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida
  • University of Chicago Medical CenterChicago, Illinois
  • Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterBaltimore, Maryland
  • Dana-Faeber Cancer InstituteBoston, Massachusetts
  • Henry Ford HospitalDetroit, Michigan
  • Cancer and Hematology Centers of Western MichiganGrand Rapids, Michigan
  • Washington University School of MedicineSt Louis, Missouri
  • Hackensack Meridian Health-Southern Ocean Medical CenterManahawkin, New Jersey
  • Memorial Sloan-Kettering Cancer Center (Mskcc) - New YorkNew York, New York
  • Montefiore Medical Center PrimeThe Bronx, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 25, 2026. Always confirm current availability with the study team.

View original record ↗