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

RecruitingPhase 1

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)

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

About the study

The primary objective of this study is to evaluate the safety and tolerability of subcutaneous (SC) tarlatamab.

What is being tested

Sponsor: Amgen · Participants: 220 · Started: Oct 7, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06598306

Locations in the U.S.

CaliforniaUniversity of Southern California, Norris Comprehensive Cancer Center, Los Angeles
IllinoisUniversity of Illinois Chicago, Chicago
MichiganTrinity Health Saint Joseph Mercy Ann Arbor, Ann Arbor
South DakotaAvera Cancer Institute, Sioux Falls
TexasUniversity of Texas MD Anderson Cancer Center, Houston
WashingtonSwedish Cancer Institute, Seattle

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.