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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 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

400

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Australia
    • South Australia
      • Elizabeth Vale, South Australia, Australia, 5112
        • Rekruttering
        • Lyell McEwin Hospital
  • Forente stater
    • Florida
      • Orlando, Florida, Forente stater, 32806
        • Rekruttering
        • University of Florida Health Cancer Center at Orlando Health
    • Michigan
      • Grand Rapids, Michigan, Forente stater, 49503
        • Rekruttering
        • Cancer and Hematology Centers of Western Michigan
    • Nebraska
      • Omaha, Nebraska, Forente 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
  • Sveits
      • Zurich, Sveits, 8091
        • Rekruttering
        • Universitaetsspital Zuerich

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Tarlatamab SC
Participants will receive Tarlatamab via SC injection
Legemiddel: Tarlatamab
Administered via SC injection or IV infusion
Andre navn:
  • AMG 757
  • IMDELLTRA
Aktiv komparator: Tarlatamab IV
Participants will receive Tarlatamab via IV infusion
Legemiddel: Tarlatamab
Administered via SC injection or IV infusion
Andre navn:
  • AMG 757
  • IMDELLTRA

Hva måler studien?

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
Total overlevelse (OS)
Tidsramme: Opptil ca 4 år
Opptil ca 4 år
Svar på spørreskjema for pasientrapporterte uønskede hendelser (PRO-CTCAE)
Tidsramme: Opptil ca 4 år
Opptil ca 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Amgen

Etterforskere

  • Studieleder: MD, Amgen

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

28. august 2026

Primær fullføring (Antatt)

24. september 2027

Studiet fullført (Antatt)

30. juli 2030

Datoer for studieregistrering

Først innsendt

12. august 2026

Først innsendt som oppfylte QC-kriteriene

20. august 2026

Først lagt ut (Faktiske)

21. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 20250046

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (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.

Tilgangskriterier for IPD-deling

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 Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere