Status:
RECRUITING
Subcutaneous Tarlatamab in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)
Lead Sponsor:
Amgen
Collaborating Sponsors:
BeOne Medicines
Conditions:
Extensive Stage Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The primary objective of this study is to evaluate the safety and tolerability of subcutaneous (SC) tarlatamab.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 27 2030
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT06598306
Start Date
October 7 2024
End Date
March 27 2030
Last Update
December 1 2025
Active Locations (30)
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1
University of Southern California, Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
2
University of Illinois Chicago
Chicago, Illinois, United States, 60612
3
Trinity Health Saint Joseph Mercy Ann Arbor
Ann Arbor, Michigan, United States, 48106
4
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105