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New drug shows promise for tough lung cancer

NCT ID NCT05280470

Disease control Sponsor: Daiichi Sankyo Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 study tests a drug called ifinatamab deruxtecan (I-DXd) in 187 people with extensive-stage small cell lung cancer that has already been treated with chemotherapy. The drug is designed to target and kill cancer cells. Researchers are checking how many patients' tumors shrink and what side effects occur. The goal is to see if this drug can help control the cancer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ifinatamab deruxtecan (I-DXd)
What this could lead to
If it works, this could offer a new treatment option for people with advanced small cell lung cancer who have already tried chemotherapy.
What could go wrong
This is a mid-stage trial with only 187 participants, so results may not apply to everyone. The drug can cause side effects, and it is not yet proven to be safe or effective.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

187 people

The number who actually took part.

Started

Mar 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion 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. 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. * 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.

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Conditions

The condition(s) this trial relates to.

small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Extensive-stage small-cell lung cancer

Contacts and locations

Locations

  • Asan Medical Center

    Seoul, 5505, South Korea

  • CHU de Montpellier - Hôpital Arnaud de Villeneuve

    Montpellier, 34295, France

  • Cancer and Hematology Centers of Western Michigan

    Grand Rapids, Michigan, 49503, United States

  • Centre Hospitalier Intercommunal de Créteil

    Créteil, 94000, France

  • Centre Leon Berard

    Lyon, 69008, France

  • Chang Gung Medical Foundation - Kaohsiung Branch

    Kaohsiung City, 83301, Taiwan

  • Chang Gung Memorial Hospital Linkou

    Taoyuan, 333, Taiwan

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, 15006, Spain

  • Dana-Faeber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Duke University Health System

    Durham, North Carolina, 27703, United States

  • Evangelische Lungenklinik Berlin

    Berlin, 13125, Germany

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032, China

  • Guangdong Provincial People'S Hospital

    Guangdong, 510000, China

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612, United States

  • Hackensack Meridian Health-Southern Ocean Medical Center

    Manahawkin, New Jersey, 08050, United States

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Highlands Oncology Group

    Springdale, Arkansas, 72762, United States

  • Hopital Arnaud de Villeneuve

    Montpellier, 34295, France

  • Hopital Tenon

    Paris, 75020, France

  • Hospital Regional Universitario Malaga

    Málaga, 29011, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Vall Dhebron

    Barcelona, 08035, Spain

  • Hospital Virgen Macarena

    Seville, 41009, Spain

  • Hunan Cancer Hospital

    Changsha, 410013, China

  • Hôpital Nord - Chu Marseille

    Marseille, 13915, France

  • Ico L'Hospitalet - Hospital Duran I Reynals

    L'Hospitalet de Llobregat, 08908, Spain

  • Institut Curie - Site de Paris

    Paris, 75005, France

  • Jilin Cancer Hospital

    Changchun, 130012, China

  • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland, 21287, United States

  • Kanagawa Cancer Center

    Yokohama, 241-8515, Japan

  • Kindai University Hospital

    Ōsaka-sayama, 589-8511, Japan

  • Linyi Cancer Hospital

    Linyi, 276000, China

  • Memorial Sloan-Kettering Cancer Center (Mskcc) - New York

    New York, New York, 10065, United States

  • Millennium Physicians Association, Llp

    Houston, Texas, 77090, United States

  • Montefiore Medical Center Prime

    The Bronx, New York, 10461, United States

  • National Cancer Center

    Goyang-si, 10408, South Korea

  • National Cancer Center Hospital

    Chūōku, 104-0045, Japan

  • National Cancer Center Hospital East

    Kashiwa, 277-8577, Japan

  • National Cheng Kung University Hospital Nckuh

    Tainan, 704, Taiwan

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • Osaka International Cancer Institute

    Osaka, 541-8567, Japan

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Sarah Cannon (Tennessee Oncology - Nashville)

    Nashville, Tennessee, 37203, United States

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Shizuoka Cancer Center

    Nagaizumi-chō, 411-8777, Japan

  • Taichung Veterans General Hospital

    Taichung, 40705, Taiwan

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • The Cancer Institute Hospital of Jfcr

    Kōtoku, 135-8550, Japan

  • The Cancer Specialists, Llc

    Jacksonville, Florida, 32256, United States

  • Union Hospital of Tongji Medical College Huazhong University of Science and Technology

    Wuhan, 430022, China

  • Universitaetsklinikum Essen

    Essen, 45147, Germany

  • University of Chicago Medical Center

    Chicago, Illinois, 60637, United States

  • University of Washington Medical Center

    Seattle, Washington, 98195, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • West China Hospital, Sichuan University

    Chengdu, 610041, China

  • Zhejiang Cancer Hospital

    Hangzhou, 310022, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.