Tarlatamab by injection or drip in small cell lung cancer that returned
Compares two ways of giving tarlatamab in adults whose small cell lung cancer returned.
Plain-language title generated from the registry record
Registry title: Phase 3 Trial of Tarlatamab (SC vs IV) in Extensive-Stage Small Cell Lung Cancer After Platinum Based First-line Chemotherapy (ES-SCLC)
Key facts
- Where
- Zurich, SwitzerlandSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 99 years old?
Source: NCT07778316, who can take part
Where in Switzerland
- Universitaetsspital ZuerichZurich, SwitzerlandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Amgen
- Trial code
- NCT07778316
- Record updated
- 17 September 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: 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; 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; 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; Disease Related; 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; History of allergy or hypersensitivity to similar products (eg, drugs with a similar chemical structure or other monoclonal antibody) or any excipient; Other Exclusions; 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; 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; Known sensitivity or a contraindication to any of the products or components; 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.