Actively Recruiting
Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC)
Led by Amgen · Updated on 2026-05-07
160
Participants Needed
3
Research Sites
265 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of this trial is to evaluate the safety and tolerability of tarlatamab in combination with ZL-1310 with or without durvalumab and to determine the maximum tolerated combination dose (MTCD) and/or recommended phase 2 dose (RP2D) of ZL-1310 in combination with tarlatamab.
CONDITIONS
Official Title
Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older (or legal adult age in country if older than 18) at consent
- Histologically or cytologically confirmed small cell lung cancer
- For Part 1, disease progressed or recurred after at least one platinum-based therapy
- For Parts 1 and 2, progressed or recurred after at least one platinum-based therapy; no prior tarlatamab in Cohort 2-1
- For Part 3, extensive-stage SCLC with no prior systemic treatment except one cycle of platinum chemotherapy
- Prior treatment for limited-stage SCLC allowed if before extensive-stage diagnosis
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- At least one measurable lesion per RECIST v1.1 within 21 days before screening, not previously irradiated
- Adequate blood, coagulation, kidney, liver, lung, and heart function
You will not qualify if you...
- Symptomatic central nervous system metastases (treated brain metastases allowed if criteria met)
- History of interstitial lung disease or pneumonitis
- Thoracic radiation therapy within 90 days before first trial dose
- Prior treatment with any delta-like ligand 3 (DLL3)-directed therapy
- Prior use of topoisomerase I inhibitors or antibody-drug conjugates with topoisomerase I inhibitor payload
- Use of strong CYP3A4 or CPY2D6 inhibitors within 14 days or 5 half-lives before first trial dose
- Participation in any other tarlatamab clinical trial
AI-Screening
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Trial Site Locations
Total: 3 locations
1
New York University Cancer Institute
New York, New York, United States, 10016
Actively Recruiting
2
Baptist Cancer Center
Memphis, Tennessee, United States, 38120
Actively Recruiting
3
Next Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
A
Amgen Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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