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New hope for aggressive lung cancer: combo therapy enters human trials

NCT ID NCT06362252

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug called ifinatamab deruxtecan (I-DXd) combined with standard immunotherapy (atezolizumab) and sometimes chemotherapy (carboplatin) for people with extensive-stage small cell lung cancer who have not yet been treated. The goal is to see if the combination is safe and helps control the cancer. About 123 adults will take part. This is an early-phase trial, so the main focus is safety and finding the right dose.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 123 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

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.

A full list of inclusion/exclusion criteria are available in the protocol. Inclusion Criteria Participants must meet all of the following criteria to be eligible for enrollment into the study: 1. Sign and date the informed consent form (ICF), prior to the start of any study-specific qualification procedures. 2. Adults ≥18 years or the minimum legal adult age (whichever is greater) at the time the ICF is signed. 3. Has histologically or cytologically confirmed diagnosis of ES-SCLC who will require first-line (IL) therapy. 4. For Cohort 1, participant has received 4 cycles of 1L induction therapy with carboplatin, etoposide, and atezolizumab for ES-SCLC with ongoing CR PR, CR, or SD per RECIST v1.1 assessed by the investigator. For Cohort 2, participant has received no prior treatment for ES-SCLC. 5. For Cohort 2, participant has at least one measurable lesion according to RECIST v1.1 on computed tomography (CT) or magnetic resonance imaging (MRI) as assessed by the investigator. 6. For Cohort 2, participant must have at least one lesion, amenable to core biopsy, and must consent to provide a pretreatment biopsy tissue sample and on-treatment biopsy. 7. Has ECOG PS of ≤1 (assessed within 7 days before enrollment/randomization). 8. Has adequate organ and bone marrow function within 7 days before the start of study treatment as specified in the study protocol. 9. A female subject of childbearing potential (POCBP) is eligible to participate if the following conditions are met: 1. Subject is not pregnant as confirmed by highly sensitive pregnancy test during Screening (within 3 days prior to enrollment/randomization) 2. Subject does not breastfeed during the treatment period and for at least 8/5/6 months after last dose of I-DXd/atezolizumab/carboplatin, respectively. 3. Subject agrees to adhere to a contraceptive method that is highly effective and agrees not to donate eggs (ova, oocytes) to others or freeze/store eggs during the treatment period and for at least the time needed to eliminate each study drug after the last dose. The length of time required to continue contraception and avoid donating/freezing eggs after last dose for I-DXd/atezolizumab/carboplatin is 8/5/6 months, respectively. Preservation of eggs may be considered prior to first dose of study drug. 10. A male subject capable of producing sperm is eligible to participate if he agrees to the following during the intervention period and for at least the time needed to eliminate each study drug. The length of time required to continue contraception and avoid donating sperm after last dose for I-DXd/atezolizumab/carboplatin is 6/5/6 months, respectively. 1. Avoid donating sperm. 2. Adhere to either of the contraception methods: true abstinence from penile-vaginal intercourse or uses a penile/external condom when having penile-vaginal intercourse with a non-subject of childbearing potential plus partner use of an additional contraceptive method. 11. Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions. Exclusion Criteria Participants who meet any of the following criteria will be disqualified from entering the study: 1. Has received prior treatment with orlotamab, enoblituzumab, or other B7-H3 targeted agents, including I-DXd. 2. Prior discontinuation of an ADC that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities. 3. Has received prior treatment with CD137 agonists or ICIs, including anti-cytotoxic T-cell lymphocyte-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, except for atezolizumab for Cohort 1. 4. Has inadequate washout period before enrollment/randomization as specified in the study protocol. 5. Has any of the following within the past 6 months: cerebrovascular accident, transient ischemic attack, or another arterial thromboembolic event. 6. Has clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis, defined as untreated and symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms. 7. Has clinically significant corneal disease. 8. Has uncontrolled or significant cardiovascular disease,. 9. Has history of (non-infectious) ILD/pneumonitis that required corticosteroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at Screening. 10. Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses 11. Is on chronic steroid treatment (dose of 10 mg daily or more prednisone equivalent), except for low-dose inhaled steroids (for asthma/chronic obstructive pulmonary disease, topical steroids (for mild skin conditions), or intra-articular steroid injections. 12. Has history of malignancy other than SCLC within the 5 years prior to randomization/enrollment, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, superficial gastrointestinal tract tumors, and non-muscle invasive bladder cancer curatively resected by endoscopic surgery. 13. Has history of allogeneic bone marrow, stem cell, or solid organ transplant. 14. Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE V5.0, Grade ≤1 or baseline. 15. Has history of hypersensitivity to the drug substances, inactive ingredients in the drug product or severe hypersensitivity reactions to other monoclonal antibodies. 16. Has evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection. 17. Has active or uncontrolled human immunodeficiency virus (HIV) infection. 18. Has active or uncontrolled hepatitis B or C virus (HBV or HCV) infection. 19. Has history of autoimmune disease. 20. Has any evidence of severe or uncontrolled systemic diseases. 21. Has received a live vaccine within 30 days prior to the first dose of study drug. 22. Is a female who is pregnant or breastfeeding or planning to become pregnant. 23. Has 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; alter the absorption, distribution, metabolism, or excretion of the study drug; or confound the assessment of study results. 24. Has psychological, social, familial, or logistical factors that would prevent regular follow-up

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    57 sites in 4 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Advent Health Orlando

    RECRUITING

    Orlando, Florida, 32804, United States

  • Astera Cancer Care

    RECRUITING

    East Brunswick, New Jersey, 08816, United States

  • CHU Nantes - Hôpital Guillaume et René Laënnec

    RECRUITING

    Saint-Herblain, 44805, France

  • Centre Léon Bérard

    RECRUITING

    Lyon, 69008, France

  • Chu Rennes - Hopital Pontchaillou

    RECRUITING

    Rennes, 35000, France

  • Columbia University Hervert Irving Comprehensive Cancer Center

    RECRUITING

    New York, New York, 10032, United States

  • Dartmouth-Hitchcock Medical Center

    RECRUITING

    Lebanon, New Hampshire, 03766, United States

  • David Geffen School of Medicine

    NOT_YET_RECRUITING

    Los Angeles, California, 90095, United States

  • Fujita Health University Hospital

    RECRUITING

    Toyoake-shi, 470-1192, Japan

  • Henry Ford Hospital

    ACTIVE_NOT_RECRUITING

    Detroit, Michigan, 48202, United States

  • Hoag Memorial Hospital Presbyterian

    RECRUITING

    Newport Beach, California, 92663, United States

  • Hopital Albert Calmette - Chu Lille

    RECRUITING

    Lille, 59037, France

  • Hopital Tenon

    RECRUITING

    Paris, 75020, France

  • Hospital Alvaro Cunqueiro

    RECRUITING

    Vigo, 36312, Spain

  • Hospital Clinic de Barcelona

    RECRUITING

    Barcelona, 08036, Spain

  • Hospital General Universitario Gregorio Marañon

    RECRUITING

    Madrid, 28007, Spain

  • Hospital Regional Universitario de Malaga

    RECRUITING

    Málaga, 29010, Spain

  • Hospital Universitari Vall D'Hebron

    RECRUITING

    Barcelona, 8035, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Ramon Y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • Hospital Universitario Virgen Del Rocio

    RECRUITING

    Seville, 41013, Spain

  • Hospital Universitario Virgen Macarena

    RECRUITING

    Seville, 41009, Spain

  • Hôpital Foch

    RECRUITING

    Suresnes, 92151, France

  • Hôpital de la Timone

    RECRUITING

    Marseille, 13005, France

  • ICO l'Hospitalet - Hospital Duran i Reynals

    RECRUITING

    L'Hospitalet de Llobregat, 08908, Spain

  • Ico Girona - Hospital Universitari de Girona Dr Josep Trueta

    RECRUITING

    Girona, 17007, Spain

  • Institut Curie - Site de Paris

    RECRUITING

    Paris, 75005, France

  • Institut Gustave Roussy

    NOT_YET_RECRUITING

    Villejuif, 94805, France

  • John Theurer Cancer Center At Hackensack Umc

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Kansai Medical University Hospital

    RECRUITING

    Hirakata-shi, 573-1191, Japan

  • Kindai University Hospital

    RECRUITING

    Ōsaka-sayama, 589-8511, Japan

  • Lancaster General Hospital - Ann B Barshinger Cancer Institute

    RECRUITING

    Lancaster, Pennsylvania, 17601, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Mayo Clinic Arizona

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic-Jacksonville

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10021, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • Montefiore Medical Center

    RECRUITING

    New York, New York, 10461, United States

  • NHO Himeji Medical Center

    RECRUITING

    Himeji-shi, 670-8520, Japan

  • NYU Langone Hospital - Long Island

    RECRUITING

    Mineola, New York, 11501, United States

  • National Cancer Center Hospital East

    RECRUITING

    Kashiwa, 277-8577, Japan

  • New York University Cancer Center - Laura and Isaac Perlmutter Cancer Center At Nyu Langone

    RECRUITING

    Mineola, New York, 11501, United States

  • Next Madrid

    RECRUITING

    Madrid, 28223, Spain

  • Next Virginia

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Niigata Cancer Center Hospital

    RECRUITING

    Niigata, 951-8566, Japan

  • Northwest Cancer Specialists, P.C.-Vancouver

    RECRUITING

    Vancouver, Washington, 98684, United States

  • Okayama University Hospital

    RECRUITING

    Okayama, 700-8558, Japan

  • Regents of the University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Scri Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Shizuoka Cancer Center

    RECRUITING

    Nagaizumi-cho, 411-8777, Japan

  • Social Welfare Organization Saiseikai Imperial Gift Foundation, Inc. Saiseikai Kumamoto Hospital

    RECRUITING

    Kumamoto, 861-4193, Japan

  • The Cancer Institute Hospital of Jfcr

    RECRUITING

    Kōtoku, 135-8550, Japan

  • Thomas Jefferson University Hospital - Central

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • Tokushima University Hospital

    RECRUITING

    Tokushima, 770-8503, Japan

  • University of Alabama -Birmingham

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • University of Pennsylvania, Abramson Cancer Center

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

More trials for these conditions

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