Actively Recruiting
A Phase 2 Study of Tarlatamab (DLL3-CD3 Bispecific T Cell Engager) as First-Line Therapy in Patients With Extensive-Stage Small-Cell Lung Cancer
Led by Asrar Alahmadi · Updated on 2026-02-20
39
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Asrar Alahmadi
Lead Sponsor
A
Amgen
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of tarlatamab, a bispecific antibody, as a first-line treatment for patients with extensive-stage small cell lung cancer (SCLC) that has spread beyond its original site. This aggressive cancer has a low 5-year survival rate. Tarlatamab targets DLL3 on tumor cells and CD3 on T-cells, potentially interfering with tumor growth and spread. This is a phase II trial aiming to assess progression-free survival and monitor rapid disease progression early in treatment. Patients receive tarlatamab through intravenous infusions over 60 minutes on days 1, 8, and 15 during the first 28-day cycle, then on days 1 and 15 of subsequent cycles if there is no disease progression or unacceptable side effects. Safety and response are assessed after 4 weeks, with further scans every 8 weeks. If rapid disease progression occurs, patients may start standard platinum-based chemotherapy and immune checkpoint inhibitors. After treatment completion, patients are followed for up to 2 years with regular check-ups. During the study, participants undergo various assessments including biopsies, blood draws, CT scans, MRI, echocardiography, and questionnaires to monitor safety, tumor response, and quality of life. Researchers measure outcomes like progression-free survival, overall survival, tumor response rates, and safety events. Monitoring continues for up to 2 years after treatment, with follow-up visits every 3 months after an initial 30-day post-treatment check.
CONDITIONS
Brief Title
Tarlatamab for the Treatment of Extensive Stage Small-cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent and HIPAA authorization
- Age 18 years or older at consent
- ECOG performance status of 0 to 2
- New diagnosis of extensive-stage small cell lung cancer, including certain recurrent cases
- Measurable disease by RECIST v1.1
- Brain MRI completed; eligible if treated or asymptomatic brain metastases meet criteria
- Adequate blood counts and organ function (ANC, platelets, hemoglobin, lymphocytes, kidney and liver function)
- Oxygen saturation of at least 90% on room air
- Stable COPD patients on oxygen for at least 6 months may be eligible
- Normal heart function (LVEF ≥ 50%) and no significant heart or ECG abnormalities
- Ability to understand and comply with study procedures
- Availability of archival tumor tissue for testing
- Willingness to provide blood samples as required
You will not qualify if you...
- Participation in another investigational treatment trial within 4 weeks
- Prior or concurrent malignancies interfering with study assessment
- Symptomatic brain metastases or leptomeningeal disease
- Significant recent cardiovascular disease or unstable conditions
- Active uncontrolled CNS diseases such as recent stroke or epilepsy
- Active infections requiring intravenous antibiotics
- Active hepatitis or uncontrolled HIV infection
- Known allergy to tarlatamab components
- Prior treatment for small cell lung cancer except certain limited-stage cases
- Major surgery within 30 days without full recovery
- Active autoimmune or immune deficiency diseases requiring systemic treatment
- Solid organ transplant history
- Interstitial lung disease or active pneumonitis
- Psychiatric or substance abuse disorders interfering with study compliance
- Recent live vaccinations or certain COVID-19 vaccines
- Unwillingness to use effective birth control during and after the study
- Symptomatic fluid buildup requiring frequent drainage
- Uncontrolled respiratory symptoms or risk of respiratory failure
- Any condition that poses safety risks or may interfere with study participation as judged by the investigator
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment including imaging and lab tests
Duration - Cycles repeat every 28 days until disease progression or unacceptable toxicity
Participants receive tarlatamab intravenously on specific days in each 28-day cycle until disease progression or unacceptable toxicity.
Infusions on days 1, 8, and 15 of cycle 1, then days 1 and 15 of subsequent cycles; safety response assessment scan after 4 weeks; response assessment scans every 8 weeks
Duration - Up to 2 years after treatment completion
After completing treatment, participants are followed to monitor health status and survival.
Visits at 30 days after treatment, then every 3 months for up to 2 years
Trial Site Locations
Total: 1 location
1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
T
The Ohio State University Comprehensive Cancer Center
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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