Tarlatamab for the Treatment of Extensive Stage Small-cell Lung Cancer
A Front-Line Window-of-Opportunity Phase 2 Study of Tarlatamab (Bispecific T Cell Engager: DLL3-CD3) in Patients With Extensive-Stage Small-Cell Lung Cancer
2 other identifiers
interventional
39
1 country
1
Brief Summary
This phase II trial tests the effect of tarlatamab in treating patients with small cell lung cancer (SCLC) that has spread from where it first started to other parts of the body (extensive-stage). SCLC is an aggressive cancer which has a low 5-year survival rate. Tarlatamab is a bispecific antibody that can bind to two different antigens at the same time. Tarlatamab binds to DLL3 which is a protein found on the surface of some types of tumor cells, including small-cell lung cancer, and to CD3 which is present on immune system T-cells (a type of white blood cell) and may interfere with the ability of tumor cells to grow and spread. This may increase the length of time to progression (growing, spreading, or getting worse) and help patients with extensive-stage SCLC live longer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2026
CompletedFirst Posted
Study publicly available on registry
February 20, 2026
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
February 20, 2026
February 1, 2026
1.8 years
February 13, 2026
February 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
6-month progression-free survival (PFS)
Will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 or death as a result of any cause. Will be calculated as the proportion of patients who are progression-free and alive divided by the total number of evaluable patients. Exact binomial 95% confidence intervals (CIs) for the 6-month PFS true rate will be calculated.
From the initiation of investigational therapy to progression, symptomatic deterioration, or death due to any cause, whichever comes first, assessed up to 6 months
Rapid progressive disease (PD) on tarlatamab rate probability (Interim analysis for futility monitoring)
Will be measured by RECIST v 1.1. Will be measured by the proportion of patients who have clinical and rapid clinical and radiological progression and move on to receive subsequent standard of care platinum-based chemotherapy and immune checkpoint inhibitors divided by the total number of evaluable patients. Exact binomial 95% CIs for the tarlatamab failure true rate will be calculated.
Within 4 weeks of starting tarlatamab
Secondary Outcomes (11)
Rate of all adverse events (AEs)
Up to 30 days after last dose of study treatment
Rate of all cytokine release syndrome
Up to 30 days after last dose of study treatment
Rate of all immune effector cell associated neurotoxicity syndrome
Up to 30 days after last dose of study treatment
Overall objective response rate (ORR)
Up to 2 years after last dose of study treatment
Duration of response (DOR)
From first occurrence of a documented objective response to the time of disease progression or death from any cause, whichever comes first, assessed up to 2 years after last dose of study treatment
- +6 more secondary outcomes
Study Arms (1)
Treatment (tarlatamab)
EXPERIMENTALPatients receive tarlatamab IV over 60 minutes on days 1, 8, and 15 of cycle 1, then on days 1 and 15 of remaining cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions
Undergo biopsies
Undergo blood sample collection
Undergo computed tomography
Undergo MRI
Undergo MUGA
Given IV
Eligibility Criteria
You may qualify if:
- Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information
- NOTE: HIPAA authorization may be included in the informed consent or obtained separately
- Age ≥ 18 years at the time of consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2
- Have a histologically or cytologically documented new diagnosis of the extensive-stage (i.e., metastatic and/or recurrent) SCLC. Patients with multiple lung nodules and/or lymph node involvement that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan are allowed
- Recurrent limited-stage SCLC disease after 6 months of completing standard-of-care systemic platinum-based chemotherapy and radiation can be considered after discussion with the sponsor
- Measurable disease according to RECIST v 1.1
- All patients must have brain MRI. Subjects with brain metastases are eligible provided they meet the following criteria:
- Patients with treated brain metastases are eligible if they completed definitive therapy at least 1 week prior to the first dose of tarlatamab, are asymptomatic (unless symptoms are deemed irreversible by the investigator), and on stable dose of steroids (=\< 10 mg prednisone equivalent) for at least 7 days prior to study treatment
- Absolute neutrophil count (ANC) ≥ 1500 cells/uL
- Platelets ≥ 100,000/uL
- Hemoglobin ≥ 9.0 g/dL
- Lymphocyte count ≥ 500/uL
- Estimated glomerular filtration rate (eGFR) based on MDRD (Modification of Diet in Renal Disease) calculation ≥ 30 mL/min/1.73 m\^2
- Total bilirubin \< 1.5 x upper limit of normal (ULN) (or \< 2 x ULN for subjects with liver metastases, or \< 3 x ULN for subjects with known Gilbert disease)
- +10 more criteria
You may not qualify if:
- Patients currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy within 4 weeks of the first dose of treatment
- Patients with a prior or concurrent malignancy whose natural history or treatment could potentially interfere with the safety or efficacy assessment of the investigational regimen are not eligible for this trial
- Symptomatic brain metastases and/or leptomeningeal disease
- Clinically significant cardiovascular disease per the investigator. Examples include unstable arrhythmia, unstable angina, myocardial infarction, and/or symptomatic congestive heart failure (New York Heart Association class II) within 3 months of the first dose of tarlatamab
- Current history of active and uncontrolled central nervous system (CNS) disease, such as stroke, transient ischemic attack, epilepsy, CNS vasculitis, or neurodegenerative disease
- Patients with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 6 months and have no residual neurologic deficits as judged by the investigator are permitted to enroll
- Patients with a history of epilepsy who have had controlled symptoms and no seizures in the past 2 years are allowed
- Subject with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of tarlatamab administration
- Subject has known active infection requiring parenteral antibiotic treatment. Upon completion of parenteral antibiotics and resolution of symptoms, the subject may be considered eligible for the study from an infection standpoint
- Subjects with active hepatitis or HIV infection, testing is required
- Patients with a past or resolved hepatitis B virus (HBV) infection (defined as the presence of hepatitis B core antibody \[anti-HBc\] and absence of hepatitis B virus surface antigen \[HBsAg\]) are eligible
- In patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA
- Subjects with HIV/AIDS with adequate antiviral therapy to control viral load (i.e., undetectable) and lymphocyte count would be allowed if they are stable and have been on treatment for ≥ 4 weeks prior to the first dose of study drug(s)
- Subjects with viral hepatitis with controlled viral load would be allowed while on suppressive antiviral therapy
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Asrar Alahmadilead
- Amgencollaborator
Study Sites (1)
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Asrar AlAhmadi, MBBS
Ohio State University Comprehensive Cancer Center
Central Study Contacts
The Ohio State University Comprehensive Cancer Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Masking Details
- Patients will receive an early saftey response assessment scan after 4 weeks of starting treatment. Pateints with rapid disease progression will immediatly start standard of care platinum based chemotherapy and immune checkpoint inhibitors.
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 13, 2026
First Posted
February 20, 2026
Study Start
April 1, 2026
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
February 20, 2026
Record last verified: 2026-02