DeLLphi-308: Tarlatamab for Extensive Stage Small Cell Lung Cancer

This study is testing a new drug called tarlatamab, given as a shot under the skin (subcutaneous injection), for people with extensive stage small cell lung cancer. This is for individuals whose cancer has progressed or returned after at least one platinum-based chemotherapy. The main goal is to understand how safe tarlatamab is and how well people tolerate it. Researchers will be looking for side effects and changes in vital signs over about two years. This study is currently recruiting about 220 participants.

Study design
This is an interventional study planning to enroll 220 participants. The phase is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for treatment-emergent adverse events and changes in vital signs for up to approximately 24 months.

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NCT06598306

Subcutaneous Tarlatamab in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)

Recruiting
PHASE1Ages 18+InterventionalBasic science
Amgen
~220 participants
Updated 2026-06-26 on ClinicalTrials.gov
What's tested:Tarlatamab

At a glance

Recruiting sites
31 of 31 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Dose-limiting toxicities (DLTs)
Measured over Up to day 21
+3 more outcomes measured
Extensive Stage Small Cell Lung Cancer
31 sites across 21 states
Belgium3
Poland3
Switzerland3
Turkey (Türkiye)3
New South Wales2
Germany2
California1
Illinois1
  • MD · STUDY_DIRECTOR · Amgen

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Eligibility criteria

Inclusion

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.
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.

Exclusion

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.
  • Number of Participants with Dose-limiting toxicities (DLTs)Up to day 21
  • Number of Participants with Treatment-emergent Adverse Events (TEAEs)Up to approximately 24 months
  • Number of Participants with Changes in Vital SignsUp to approximately 24 months
  • Number of Participants with Clinically Significant Changes in Clinical Laboratory TestsUp to approximately 24 months