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

Launched by AMGEN · Sep 13, 2024

Keywords

ClinConnect Summary

This clinical trial, called DeLLphi-308, is studying a new treatment called tarlatamab for patients with extensive stage small cell lung cancer (ES-SCLC). The main goal of the study is to understand how safe this treatment is and how well people can tolerate it when given as an injection under the skin. The trial is currently looking for participants aged 18 and older who have been diagnosed with ES-SCLC that has returned or gotten worse after receiving at least one type of chemotherapy that includes platinum. To be eligible, participants should have good overall health, as measured by a performance scale (ECOG score of 0 or 1), and must be able to receive injections in the abdomen or thigh.

If you decide to participate, you will receive tarlatamab and be monitored closely for any side effects or reactions to the treatment. It's important to note that certain patients, such as those with untreated brain metastases or who have received specific prior therapies, may not be eligible for this trial. This study aims to provide more information about how well tarlatamab works and its safety profile, which could help improve treatment options for others in the future.

Gender

ALL

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 (and/or thigh).
• • 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.