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 uppdaterad 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.
Studieöversikt
Studietyp
Interventionell
Inskrivning (Beräknad)
400
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Amgen Call Center
- Telefonnummer: 866-572-6436
- E-post: medinfo@amgen.com
Studieorter
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South Australia
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Elizabeth Vale, South Australia, Australien, 5112
- Rekrytering
- Lyell McEwin Hospital
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Florida
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Orlando, Florida, Förenta staterna, 32806
- Rekrytering
- University of Florida Health Cancer Center at Orlando Health
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Michigan
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Grand Rapids, Michigan, Förenta staterna, 49503
- Rekrytering
- Cancer and Hematology Centers of Western Michigan
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Nebraska
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Omaha, Nebraska, Förenta staterna, 68130
- Rekrytering
- Oncology Hematology West PC
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Tokyo
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Bunkyo-ku, Tokyo, Japan, 113-8677
- Rekrytering
- Tokyo Metropolitan Komagome Hospital
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Shanghai, Kina, 200433
- Rekrytering
- Shanghai Pulmonary Hospital
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100142
- Rekrytering
- Beijing Cancer Hospital
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Beijing, Beijing Municipality, Kina, 100020
- Rekrytering
- Beijing Chaoyang Hospital
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Zurich, Schweiz, 8091
- Rekrytering
- Universitaetsspital Zuerich
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Tarlatamab SC
Participants will receive Tarlatamab via SC injection
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Administered via SC injection or IV infusion
Andra namn:
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Aktiv komparator: Tarlatamab IV
Participants will receive Tarlatamab via IV infusion
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Administered via SC injection or IV infusion
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Area Under the Curve From Cycle 2 Day 1 to Day 15 (AUC C2D1-D15) of Tarlatamab
Tidsram: From Cycle 2 Day 1 to Day 15 (each cycle is 28 days)
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From Cycle 2 Day 1 to Day 15 (each cycle is 28 days)
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Predose Concentration (Ctrough) of Tarlatamab
Tidsram: On Cycle 2 Day 15 (each cycle is 28 days)
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On Cycle 2 Day 15 (each cycle is 28 days)
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Total överlevnad (OS)
Tidsram: Upp till cirka 4 år
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Upp till cirka 4 år
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Svar på frågeformulär för patientrapporterade biverkningar (PRO-CTCAE)
Tidsram: Upp till cirka 4 år
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Upp till cirka 4 år
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Objective response (OR) per Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)
Tidsram: Up to approximately 4 years
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Up to approximately 4 years
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Progression free survival (PFS) per RECIST v1.1
Tidsram: Up to approximately 4 years
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Up to approximately 4 years
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Duration of response (DOR) per RECIST v1.1
Tidsram: Up to approximately 4 years
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Up to approximately 4 years
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Disease control (DC) per RECIST v1.1
Tidsram: Up to approximately 4 years
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Up to approximately 4 years
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Number of participants with treatment-emergent adverse events (TEAEs) and Treatment-related Adverse Events (TRAEs)
Tidsram: Up to approximately 4 years
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Up to approximately 4 years
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Change from Baseline in Visual Analogue Scale (VAS) score of the EuroQol5 Dimension (EQ-5D-5L)
Tidsram: Up to approximately 4 years
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Up to approximately 4 years
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Responses to Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire on symptom bother
Tidsram: Up to approximately 4 years
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Up to approximately 4 years
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Responses to Therapy Administration Satisfaction Questionnaire (TASQ)
Tidsram: Up to approximately 4 years
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Up to approximately 4 years
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Number of Participants with Anti-tarlatamab Antibody Formation
Tidsram: Up to approximately 4 years
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Up to approximately 4 years
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: MD, Amgen
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
28 augusti 2026
Primärt slutförande (Beräknad)
24 september 2027
Avslutad studie (Beräknad)
30 juli 2030
Studieregistreringsdatum
Först inskickad
12 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
20 augusti 2026
Första postat (Faktisk)
21 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
16 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 20250046
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Tidsram för IPD-delning
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.
Kriterier för IPD Sharing Access
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-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ICF
- CSR
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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