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Een onderzoek naar onderzoeksagentia bij deelnemers met eerder behandeld stadium IV niet-plaveiselcel-longkanker (NSCLC) (MK-3475-01H/KEYMAKER-U01)

23 oktober 2026 bijgewerkt door: Merck Sharp & Dohme LLC

KEYMAKER-U01 Substudie 01H: Een fase 2, gerandomiseerde, overkoepelende studie met rollende armen van onderzoeksagenten bij deelnemers met eerder behandeld stadium IV niet-plaveiselcel-niet-kleincellige longkanker (NSCLC)

Researchers are looking for new ways to treat metastatic nonsquamous non-small cell lung cancer (NSCLC) that has been treated before. Metastatic means the cancer has spread to other parts of the body. Nonsquamous means the cancer did not start in squamous cells, which are flat cells that line the inside of the lungs.

Standard treatment (usual treatment) for NSCLC is surgery, then immunotherapy with or without chemotherapy after surgery. Immunotherapy is a treatment that helps the immune system fight cancer. Chemotherapy is a medicine that works to destroy cancer cells or stop them from growing.

However, standard treatment may not work or may stop working for some people. Researchers want to know if 2 antibody drug conjugates (ADCs) can help treat metastatic nonsquamous NSCLC that did not respond (get smaller or go away) to treatment. An ADC attaches to specific targets on cancers cells and delivers treatment to destroy those cells.

Researchers will compare 2 different ADCs (the study treatments) to chemotherapy in this study. The goals of this study are to learn:

  • About the safety of the study treatments and if people tolerate them
  • How many people have the cancer respond to the study treatments

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

The master screening protocol is MK-3475-U01 (KEYMAKER-U01) - NCT04165798

Studietype

Ingrijpend

Inschrijving (Geschat)

96

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Chili
    • Region M. de Santiago
      • Santiago, Region M. de Santiago, Chili, 7500653
        • Werving
        • Centro de Estudios Clínicos SAGA ( Site 0161)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +5690556961
      • Santiago, Region M. de Santiago, Chili, 8420383
        • Werving
        • Bradfordhill ( Site 0162)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +56229490970
      • Santiago, Region M. de Santiago, Chili, 7500921
        • Werving
        • Fundación Arturo López Pérez ( Site 0160)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 56227128000
  • Duitsland
      • Berlin, Duitsland, 13353
        • Werving
        • Charite-Universitaetsmedizin Berlin ( Site 0191)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +49 30 450 553 044
    • Baden-Wurttemberg
      • Tübingen, Baden-Wurttemberg, Duitsland, 72076
        • Werving
        • Universitaetsklinik Tuebingen ( Site 0192)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +4970712982795
  • Griekenland
      • Thessaloniki, Griekenland, 570 01
        • Werving
        • European Interbalkan Medical Center ( Site 0205)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 0030 2310400213
    • Attica
      • Athens, Attica, Griekenland, 115 27
        • Werving
        • THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA"-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 0204)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 0030 2107700220
  • Hongarije
    • Bács-Kiskun county
      • Kecskemét, Bács-Kiskun county, Hongarije, 6000
        • Werving
        • Bacs-Kiskun Varmegyei Oktatokorhaz ( Site 0063)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +3676516700
    • Győr-Moson-Sopron
      • Győr, Győr-Moson-Sopron, Hongarije, 9024
        • Werving
        • Petz Aladar Egyetemi Oktato Korhaz ( Site 0062)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +3696507900
    • Jász-Nagykun-Szolnok
      • Szolnok, Jász-Nagykun-Szolnok, Hongarije, 5000
        • Werving
        • Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet ( Site 0061)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +3656503603
    • Pest County
      • Törökbálint, Pest County, Hongarije, 2045
        • Werving
        • Református Pulmonológiai Centrum ( Site 0064)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +3623511570
  • Israël
      • Haifa, Israël, 3109601
        • Werving
        • Rambam Health Care Campus ( Site 0076)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +972-4-7776234
      • Jerusalem, Israël, 9103102
        • Werving
        • Shaare Zedek Medical Center ( Site 0075)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +972-2-6555768
      • Kfar Saba, Israël, 4428164
        • Werving
        • Meir Medical Center ( Site 0071)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +97297472414
      • Petah Tikva, Israël, 4941492
        • Werving
        • Rabin Medical Center ( Site 0074)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +97239378101
      • Ramat Gan, Israël, 5265601
        • Werving
        • Sheba Medical Center ( Site 0070)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +97235307032
      • Tel Aviv, Israël, 6423906
        • Werving
        • Sourasky Medical Center ( Site 0077)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +972-3-6973082
  • Italië
      • Florence, Italië, 50134
        • Werving
        • Azienda Ospedaliera Universitaria Careggi ( Site 0173)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +393209225506
      • Milan, Italië, 20132
        • Werving
        • Ospedale San Raffaele. ( Site 0171)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +390223903829
      • Roma, Italië, 00168
        • Werving
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0174)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +390630156318
    • Lombardy
      • Milan, Lombardy, Italië, 20133
        • Werving
        • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0175)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 390223902190
  • Polen
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Polen, 60-569
        • Werving
        • Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 0153)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +48616654242
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Polen, 02-781
        • Werving
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 0151)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +48225463066
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Polen, 80-214
        • Werving
        • Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +48585844466
    • West Pomeranian Voivodeship
      • Koszalin, West Pomeranian Voivodeship, Polen, 75-581
        • Actief, niet wervend
        • Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie ( Site 0152)
  • Spanje
      • Madrid, Spanje, 28223
        • Werving
        • Hospital Universitario Quiron Madrid ( Site 0091)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 34914521987
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spanje, 08908
        • Werving
        • Institut Català d'Oncologia - L'Hospitalet ( Site 0090)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 0034932607744
  • Turkije (Türkiye)
      • Adana, Turkije (Türkiye), 01250
        • Werving
        • Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 0141)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +90 322 344 44 44
      • Ankara, Turkije (Türkiye), 06230
        • Werving
        • Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 0140)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +90 312 305 43 36
      • Ankara, Turkije (Türkiye), 06800
        • Werving
        • Ankara Bilkent Şehir Hastanesi. ( Site 0142)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +905555306271
      • Istanbul, Turkije (Türkiye), 34098
        • Werving
        • I. U. Cerrahpasa Tip Fakultesi ( Site 0144)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +902124143000
      • Izmir, Turkije (Türkiye), 35100
        • Werving
        • Ege Universitesi Hastanesi ( Site 0143)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +90 232 343 43 43
  • Verenigde Staten
    • Kentucky
      • Lexington, Kentucky, Verenigde Staten, 40536-0293
        • Werving
        • University of Kentucky Chandler Medical Center ( Site 0019)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 859-257-1000
    • Maryland
      • Baltimore, Maryland, Verenigde Staten, 21237
        • Werving
        • MedStar Franklin Square Medical Center ( Site 0033)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 443-777-7147
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Verenigde Staten, 15212
        • Werving
        • AHN Cancer Institute - Allegheny General ( Site 9501)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 412-325-5700
    • Texas
      • Dallas, Texas, Verenigde Staten, 75246-2046
        • Werving
        • Texas Oncology - DFW ( Site 8003)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 214-370-1067

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

  • Histologically or cytologically confirmed diagnosis of Stage IV nonsquamous non-small cell lung cancer (NSCLC)
  • Documented disease progression per RECIST 1.1 after receiving an anti-programmed cell death 1 protein (PD-1)/programmed cell death ligand 1 (PD-L1) treatment and platinum-based chemotherapy
  • Confirmation per local test report that epidermal growth factor receptor negative (EGFR-), anaplastic lymphoma kinase negative (ALK-), c ros oncogene 1 negative (ROS1-), or other directed therapy is not indicated as primary therapy
  • Measurable disease per RECIST 1.1 as assessed by investigator and verified by BICR
  • Life expectancy of at least 3 months
  • An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization
  • Is an individual of any sex/gender who is at least 18 years of age at the time of providing the informed consent
  • Has adequate organ function
  • If capable of producing sperm refrains from donating sperm plus either abstains from penile-vaginal intercourse or uses a penile/external condom, with contraceptive use consistent with local regulations
  • Participant/participants of childbearing potential (POCBP) is not pregnant and has a negative highly sensitive pregnancy test; and is not breastfeeding and uses a highly effective contraceptive method
  • Archival tumor tissue sample of a tumor lesion not previously irradiated has been provided
  • Has provided tissue prior to treatment randomization from a newly obtained formalin-fixed sample from a new biopsy
  • Human Immunodeficiency Virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
  • Participants who are hepatitis B surface antigen (HBsAg) positive have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization
  • Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

  • Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
  • Received radiation therapy to the lung
  • Has uncontrolled or significant cardiovascular disorder prior to randomization
  • Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
  • Participants who have adverse events (AEs) (other than alopecia) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline
  • Has known severe hypersensitivity (≥Grade 3) to study intervention and/or any of its excipients
  • Has clinically significant corneal disease
  • Has received prior radiotherapy within 2 weeks of start of study intervention, or radiation related toxicities, requiring corticosteroids
  • Has inadequate washout period prior to randomization
  • Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
  • Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
  • Has previously received docetaxel as monotherapy or in combination with other therapies
  • Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
  • Has known additional malignancy that is progressing or has required active treatment within the past 3 years
  • Has known untreated central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has evidence of any leptomeningeal disease
  • Has history of interstitial lung disease (ILD)/pneumonitis, current diagnosis of ILD, and/or suspected ILD
  • Has active autoimmune disease that has required systemic treatment in the past 2 years
  • Has active infection requiring systemic therapy
  • HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  • Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease
  • Has known history of, or active, neurologic paraneoplastic syndrome
  • Has history of allogeneic tissue/solid organ transplant
  • Have not adequately recovered from major surgery or have ongoing surgical complications

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Raludotatug Deruxtecan

Participants receive raludotatug deruxtecan (R-DXd) 5.6 mg/kg via intravenous (IV) Infusion every 3 weeks (q3w) until disease progression or discontinuation criterion is met.
Biologisch: Raludotatug Deruxtecan

IV Infusion

Andere namen:
  • R-DXd
  • DS-6000a
  • MK-5909
Geneesmiddel: 5-hydroxytryptamine subtype 3 receptor antagonist

Administered as a rescue medication per approved product label before R-DXd or I-DXd infusion

Andere namen:
  • 5-HT3-receptorantagonist
Geneesmiddel: Neurokinin-1 receptor antagonist

Administered as a rescue medication per approved product label before R-DXd or I-DXd infusion

Andere namen:
  • NK-1-receptorantagonist
Geneesmiddel: Corticosteroid

Administered as a rescue medication per approved product label before R-DXd or I-DXd infusion, and for 3 days starting 1 day prior to docetaxel administration
Experimenteel: Ifinatamab Deruxtecan

Participants receive ifinatamab deruxtecan (I-DXd) 12 mg/kg via IV infusion q3w until disease progression or discontinuation criterion is met.
Geneesmiddel: 5-hydroxytryptamine subtype 3 receptor antagonist

Administered as a rescue medication per approved product label before R-DXd or I-DXd infusion

Andere namen:
  • 5-HT3-receptorantagonist
Geneesmiddel: Neurokinin-1 receptor antagonist

Administered as a rescue medication per approved product label before R-DXd or I-DXd infusion

Andere namen:
  • NK-1-receptorantagonist
Geneesmiddel: Corticosteroid

Administered as a rescue medication per approved product label before R-DXd or I-DXd infusion, and for 3 days starting 1 day prior to docetaxel administration

Biologisch: Ifinatamab Deruxtecan

IV Infusion

Andere namen:
  • DS-7300a
  • I-DXd
  • MK-2400
Actieve vergelijker: Docetetaxel

Participants receive docetaxel 75mg/m2 via IV infusion q3w until disease progression or discontinuation criterion is met.
Geneesmiddel: Corticosteroid

Administered as a rescue medication per approved product label before R-DXd or I-DXd infusion, and for 3 days starting 1 day prior to docetaxel administration

Geneesmiddel: Docetetaxel

IV Infusion

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Objective Response Rate (ORR)
Tijdsspanne: Up to approximately 81 months

ORR is defined as the percentage of participants with Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
Up to approximately 81 months
Percentage of Participants with at Least One Adverse Event (AE)
Tijdsspanne: Up to approximately 81 months

An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The percentage of participants who experience an AE will be reported.
Up to approximately 81 months
Percentage of Participants Who Discontinued Medication Due to an AE
Tijdsspanne: Up to approximately 24 months

An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The percentage of participants who discontinue study intervention due to an AE will be reported.
Up to approximately 24 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Duration of Response (DOR)
Tijdsspanne: Up to approximately 81 months

For participants who demonstrate a confirmed CR (disappearance of all target lesions) or (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.
Up to approximately 81 months
Progression-free Survival (PFS)
Tijdsspanne: Up to approximately 81 months

PFS is defined as the time from randomization to the first documented PD or death due to any cause, whichever occurs first as assessed by RECIST 1.1. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented.
Up to approximately 81 months
Overall Survival (OS)
Tijdsspanne: Up to approximately 81 months

OS is defined as the time from randomization to death due to any cause.
Up to approximately 81 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Merck Sharp & Dohme LLC

Medewerkers

Daiichi Sankyo

Onderzoekers

  • Studie directeur: Medical Director, Merck Sharp & Dohme LLC

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

13 mei 2025

Primaire voltooiing (Geschat)

12 maart 2032

Studie voltooiing (Geschat)

12 maart 2032

Studieregistratiedata

Eerst ingediend

13 januari 2025

Eerst ingediend dat voldeed aan de QC-criteria

13 januari 2025

Eerst geplaatst (Werkelijk)

17 januari 2025

Updates van studierecords

Laatste update geplaatst (Werkelijk)

27 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

23 oktober 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 3475-01H
  • KEYMAKER-U01 (Andere identificatie: MSD)
  • MK-3475-01H (Andere identificatie: MSD)
  • U1111-1314-1785 (Register-ID: UTN)
  • 2024-518761-10-00 (Register-ID: EU CT)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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