Subcutaneous Tarlatamab in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAmgen
About this trial
The primary objective of this study is to evaluate the safety and tolerability of subcutaneous (SC) tarlatamab.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Tarlatamab
Treatment groups
220 Participants
are divided into 3 treatment groupsSponsors and collaborators
Amgen
Lead sponsor
BeOne Medicines
Collaborator
Source ClinicalTrials.gov