Actively Recruiting
Tarlatamab in Advanced Delta-like 3 (DLL3)-Expressing Tumors Including Neuroendocrine Neoplasms
Led by Jonsson Comprehensive Cancer Center · Updated on 2026-05-08
29
Participants Needed
5
Research Sites
213 weeks
Total Duration
On this page
Sponsors
J
Jonsson Comprehensive Cancer Center
Lead Sponsor
A
Amgen
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is being done to learn more about the drug tarlatamab in people with your condition. The purpose of this study is to see the efficacy (how well something works) of study treatment (tarlatamab) and whether it causes any side effects. Tarlatamab is being developed as an anti-cancer drug for tumors and is FDA-approved for extensive-stage small cell lung cancer. Tarlatamab is investigational for the purpose of this study.
CONDITIONS
Official Title
Tarlatamab in Advanced Delta-like 3 (DLL3)-Expressing Tumors Including Neuroendocrine Neoplasms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided informed consent before starting study activities
- Male or female aged 18 years or older
- Confirmed diagnosis of stage IV metastatic malignancy other than de novo small cell lung cancer or neuroendocrine prostate cancer
- Tumor types include low/intermediate grade neuroendocrine carcinoma, gastroenteropancreatic neuroendocrine neoplasms, large cell neuroendocrine carcinoma, SCLC transformed from NSCLC, extrapulmonary small cell carcinoma (excluding NEPC), or other DLL3-positive tumors
- Positive DLL3 expression on tumor biopsy (≥25% for Stage 1 or ≥1% for Stage 2)
- Disease progressed after at least one prior therapy if standard treatment exists
- Measurable disease according to RECIST 1.1
- ECOG performance status 0-1
- Adequate organ function as defined by blood counts, kidney and liver function, and coagulation tests
You will not qualify if you...
- Diagnosis of de novo small cell lung cancer or neuroendocrine prostate cancer
- Tumor not evaluable for DLL3 or DLL3 expression below 1%
- Progressive or symptomatic brain metastases; stable treated brain metastases allowed
- Interstitial lung disease or active non-infectious pneumonitis, except stable radiation-related pneumonitis
- Concurrent enrollment in other clinical trials except follow-up or observational studies
- Recent chemotherapy, immunotherapy, or small molecule inhibitors within specified timeframes
- Prior therapy targeting DLL3 pathway
- History of severe immune therapy reactions
- Recent use of systemic corticosteroids or immunosuppressants above low-dose
- Major surgery within 28 days before first study dose
- Recent live virus vaccination
- Other active malignancies within 2 years except certain treated non-invasive cancers
- Recent serious heart conditions or arterial thrombosis
- HIV infection without controlled viral load
- Active hepatitis B or C infection with detectable viral load
- Active uncontrolled infections
- Female participants who are pregnant, breastfeeding, or unwilling to use contraception
- Male participants unwilling to use contraception or abstain from sperm donation
- Known sensitivity to study drugs
- Likely inability to comply with study visits or procedures
- Other significant medical conditions posing risk or interfering with study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
UC Davis Comprehensive Cancer Center
Davis, California, United States, 95817
Actively Recruiting
2
UCI Health Chao Family Comprehensive Cancer Center
Irvine, California, United States, 92612
Actively Recruiting
3
University of California at Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
4
UC San Diego Moores Cancer Center
San Diego, California, United States, 92093
Actively Recruiting
5
University of California at San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
Research Team
C
CRU Hotline
CONTACT
C
CRU Direct line
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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