Subcutaneous Tarlatamab in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)
Sponsored by Amgen
About this study
The primary objective of this study is to evaluate the safety and tolerability of subcutaneous (SC) tarlatamab.
Where this study is enrolling
- Call 877-632-6789
University of Texas MD Anderson Cancer Center
Houston, Texas
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Who can participate
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.
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Trial data sourced from ClinicalTrials.gov.