Tests subcutaneous tarlatamab in people with small cell lung cancer
Tests subcutaneous tarlatamab for safety in adults with lung cancer.
Key facts
- Who runs it
- Amgen
- Where
- Changchun and Shanghai, ChinaSee the 2 sitesAlso in 9 other countries, 29 sites
- Trial code
- NCT06598306
- EU 2024-511838-12-00
- U1111-1308-2523
- Registry title
- Subcutaneous Tarlatamab in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)
- Status
- Recruiting
- Phase
- Phase 1
- People taking part
- 220 people, planned
- Started
- 7 Oct 2024
- Expected to end
- 24 Apr 2030
- Type of study
- Interventional, 3 groups
- Treatments tested
- Tarlatamab
- Record updated
- 26 June 2026
Who can take part
AI summary
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 with extensive stage small cell lung cancer that came back or got worse after platinum-based treatment. They must be able to have injections under the skin of the abdomen.
- Age
- 18 years or older (or the legal adult age in the country, if that is older than 18).
- Sex
- All sexes can join.
- Disease stage
- Extensive stage small cell lung cancer (ES-SCLC), confirmed by tissue or cell tests, that progressed or recurred after at least one line of platinum-based therapy. ECOG performance status of 0 or 1.
- Earlier treatment
- Must have had at least one line of platinum-based anti-cancer therapy for small cell lung cancer. People treated earlier for limited stage disease must also have had another regimen for the extensive stage disease. Must not have had DLL3 targeted therapy.
Main reasons for not taking part
- Earlier DLL3 targeted therapy
- Untreated or symptomatic brain metastases, or brain metastases needing steroids
- Leptomeningeal disease
- Needing extra oxygen at the start
- Not being able to have injections under the skin of the abdomen
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- Participants ≥ 18 years of age (or ≥ legal adult age within country if it is older than 18 years) at time of signing informed consent
- Participants with histologically or cytologically confirmed ES-SCLC that progressed or recurred following at least one line of platinum-based anti-cancer therapy for SCLC; Note: Participants with prior treatment for LS-SCLC should have also received another regimen for their recurrent, ES-SCLC disease
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
- Participants must have adequate organ function (cardiac, pulmonary, kidney, and liver)
- Participants must be able to have SC injections administered in the abdomen
- Participants without measurable disease or tumor tissue (fresh biopsy or archival) available may be permitted after discussion with and approval by Amgen Medical Monitor
Who cannot take part
- Participants that have received prior DLL3 targeted therapy
- Participants with untreated or symptomatic brain metastases or those requiring therapy with steroids
- Note: Participants with asymptomatic brain metastatic lesions are allowed following definitive treatment (Amgen Medical Monitor may approve untreated, asymptomatic brain metastasis if local therapy is not required per investigator judgment)
- Participants with leptomeningeal disease
- Participants with baseline oxygen requirement
Where in China
Also in 9 other countries, 29 sites
- Jilin Cancer HospitalChangchun, ChinaTaking people
- Shanghai Pulmonary HospitalShanghai, ChinaTaking people
About the trial
What the trial wants to find out
The primary objective of this study is to evaluate the safety and tolerability of subcutaneous (SC) tarlatamab.
The 3 groups in the trial
- Part 1 Dose ExplorationTreatment being tested
Tarlatamab will be administered as a SC injection in Part 1.
Treatment: Tarlatamab
- Part 2 Dose ExpansionTreatment being tested
Following the selection of a SC dosing regimen in Part 1, tarlatamab will be administered in Part 2 at the dose deemed safe and tolerable in Part 1.
Treatment: Tarlatamab
- Part 3 Alternative DosingTreatment being tested
Following the selection of a SC dosing regimen from Part 1 that will be used in Part 2 dose expansion, Part 3 may open to test alternative dosing of SC tarlatamab.
Treatment: Tarlatamab
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 doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Tumor Activity of Subcutaneous Tarlatamab in Subjects With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)
- Plain-language title
- Tests subcutaneous tarlatamab in people with small cell lung cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 26 June 2026