Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Phase 3 Trial of Tarlatamab (SC vs IV) in Extensive-Stage Small Cell Lung Cancer After Platinum Based First-line Chemotherapy (ES-SCLC) (DeLLphi-315)

16. september 2026 opdateret af: Amgen

A Phase 3, Open-Label, Multicenter, Randomized Study of Subcutaneous vs Intravenous Tarlatamab in Participants With Relapsed Extensive-Stage Small Cell Lung Cancer After Platinum-based First-line Chemotherapy (DeLLphi-315)

The primary objective of this study is to demonstrate non-inferiority in pharmacokinetic (PK) parameters of subcutaneous (SC) vs intravenous (IV) tarlatamab administration and to characterize the efficacy, safety, and tolerability of SC tarlatamab in participants with relapsed extensive-stage small-cell lung cancer (ES-SCLC) after platinum-based chemotherapy.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

400

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Australien
    • South Australia
      • Elizabeth Vale, South Australia, Australien, 5112
        • Rekruttering
        • Lyell McEwin Hospital
  • Forenede Stater
    • Florida
      • Orlando, Florida, Forenede Stater, 32806
        • Rekruttering
        • University of Florida Health Cancer Center at Orlando Health
    • Michigan
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • Rekruttering
        • Cancer and Hematology Centers of Western Michigan
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68130
        • Rekruttering
        • Oncology Hematology West PC
  • Japan
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8677
        • Rekruttering
        • Tokyo Metropolitan Komagome Hospital
  • Kina
      • Shanghai, Kina, 200433
        • Rekruttering
        • Shanghai Pulmonary Hospital
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100142
        • Rekruttering
        • Beijing Cancer Hospital
      • Beijing, Beijing Municipality, Kina, 100020
        • Rekruttering
        • Beijing Chaoyang Hospital
  • Schweiz
      • Zurich, Schweiz, 8091
        • Rekruttering
        • Universitaetsspital Zuerich

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Participant has provided informed consent prior to initiation of any study specific activities/procedures.
  • Age ≥ 18 years (or legal adult age within country, whichever is older) at the time of signing the informed consent.
  • Histologically or cytologically confirmed SCLC with demonstrated progression or relapse.
  • Participants who progressed or recurred following 1 platinum-based regimen.
  • Measurable disease as defined per RECIST 1.1 within the 21-day screening period.
  • Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
  • Minimum life expectancy of 12 weeks.
  • Adequate organ function.
  • History of central nervous system (CNS) metastases are allowed with considerations defined in the protocol.

Exclusion Criteria:

Disease Related

- Any previous diagnosis of non-small cell lung cancer (NSCLC), epidermal growth factor receptor (EGFR) activating mutation that has transformed to SCLC, or mixed SCLC and NSCLC histology, with exceptions defined in the protocol.

Other Medical Conditions

  • Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 6 months prior to first dose of study treatment.
  • History of arterial thrombosis (e.g., stroke or transient ischemic attack) within 6 months prior to first dose of study treatment.
  • Current evidence or history of non-infectious pneumonitis/ILD (interstitial lung disease) that required steroids or other immunosuppressive treatment.
  • History of other malignancy within the past 2 years, with exceptions defined in the protocol.
  • Presence or history of viral infection based on criteria per protocol.
  • History of solid organ transplantation.
  • Symptoms and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection requiring antibiotics within 7 days prior to the first dose study treatment.
  • Known sensitivity or a contraindication to any of the products or components.
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.

Prior/Concomitant Therapy

  • Prior systemic anticancer therapy within 30 days of enrolment
  • Prior history of severe or life-threatening events from any immune-mediated therapy.
  • Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 14 days prior to first dose of study treatment.
  • Live and live-attenuated vaccines within 28 days prior to the start of study treatment.
  • Receiving another anticancer therapy for a malignancy other than SCLC.
  • More than 1 prior line of anticancer therapy for SCLC.
  • Participation in a tarlatamab clinical trial or prior therapy with any selective inhibitor of the delta-like ligand 3 (DLL3) pathway.
  • Treatment in an alternative investigational trial within 28 days prior to enrolment.
  • History of allergy or hypersensitivity to similar products (eg, drugs with a similar chemical structure or other monoclonal antibody) or any excipient.

Other Exclusions

  • Participants unable to have SC injections administered in the abdomen or thigh.
  • Participant unlikely to be able to complete all protocol-required procedures, restrictions and requirements.
  • History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to participant safety.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Tarlatamab SC
Participants will receive Tarlatamab via SC injection
Medicin: Tarlatamab
Administered via SC injection or IV infusion
Andre navne:
  • AMG 757
  • IMDELLTRA
Aktiv komparator: Tarlatamab IV
Participants will receive Tarlatamab via IV infusion
Medicin: Tarlatamab
Administered via SC injection or IV infusion
Andre navne:
  • AMG 757
  • IMDELLTRA

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Area Under the Curve From Cycle 2 Day 1 to Day 15 (AUC C2D1-D15) of Tarlatamab
Tidsramme: From Cycle 2 Day 1 to Day 15 (each cycle is 28 days)
From Cycle 2 Day 1 to Day 15 (each cycle is 28 days)
Predose Concentration (Ctrough) of Tarlatamab
Tidsramme: On Cycle 2 Day 15 (each cycle is 28 days)
On Cycle 2 Day 15 (each cycle is 28 days)

Sekundære resultatmål

Resultatmål
Tidsramme
Samlet overlevelse (OS)
Tidsramme: Op til cirka 4 år
Op til cirka 4 år
Svar på spørgeskemaet om patientrapporterede bivirkninger (PRO-CTCAE)
Tidsramme: Op til cirka 4 år
Op til cirka 4 år
Objective response (OR) per Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)
Tidsramme: Up to approximately 4 years
Up to approximately 4 years
Progression free survival (PFS) per RECIST v1.1
Tidsramme: Up to approximately 4 years
Up to approximately 4 years
Duration of response (DOR) per RECIST v1.1
Tidsramme: Up to approximately 4 years
Up to approximately 4 years
Disease control (DC) per RECIST v1.1
Tidsramme: Up to approximately 4 years
Up to approximately 4 years
Number of participants with treatment-emergent adverse events (TEAEs) and Treatment-related Adverse Events (TRAEs)
Tidsramme: Up to approximately 4 years
Up to approximately 4 years
Change from Baseline in Visual Analogue Scale (VAS) score of the EuroQol5 Dimension (EQ-5D-5L)
Tidsramme: Up to approximately 4 years
Up to approximately 4 years
Responses to Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire on symptom bother
Tidsramme: Up to approximately 4 years
Up to approximately 4 years
Responses to Therapy Administration Satisfaction Questionnaire (TASQ)
Tidsramme: Up to approximately 4 years
Up to approximately 4 years
Number of Participants with Anti-tarlatamab Antibody Formation
Tidsramme: Up to approximately 4 years
Up to approximately 4 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Amgen

Efterforskere

  • Studieleder: MD, Amgen

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

28. august 2026

Primær færdiggørelse (Anslået)

24. september 2027

Studieafslutning (Anslået)

30. juli 2030

Datoer for studieregistrering

Først indsendt

12. august 2026

Først indsendt, der opfyldte QC-kriterier

20. august 2026

Først opslået (Faktiske)

21. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 20250046

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

IPD-delingstidsramme

Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

IPD-delingsadgangskriterier

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner