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

Summary

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

Eligibility

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.

Conditions3

Locations6 sites

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