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
- Elizabeth Vale, AustraliaSee the site
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults whose small cell lung cancer came back or got worse after one platinum-based chemotherapy. It compares tarlatamab given under the skin with tarlatamab given into a vein.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Small cell lung cancer confirmed by tissue or cell tests, with progression or relapse. Disease that can be measured on scans (RECIST 1.1). ECOG performance status 0 or 1. Life expectancy of at least 12 weeks.
- Earlier treatment
- Must have progressed or recurred after 1 platinum-based regimen. Cannot have had more than 1 prior line of anticancer therapy for SCLC. Cannot have had prior tarlatamab or another DLL3 pathway inhibitor.
Main reasons for not taking part
- Past diagnosis of non-small cell lung cancer, or mixed small cell and non-small cell histology
- Past solid organ transplant
- Non-infectious pneumonitis or interstitial lung disease that needed steroids or other immune-suppressing treatment
- Heart attack, symptomatic heart failure or arterial clot such as stroke within 6 months before the first dose
- Another cancer within the past 2 years, with exceptions set out in the protocol
Read by machine on 9 November 2026.
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 Australia
- Lyell McEwin HospitalElizabeth Vale, AustraliaTaking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.