Tarlatamab for Extensive-Stage Small-Cell Lung Cancer
This study is testing tarlatamab in people with extensive-stage small-cell lung cancer (SCLC), which means the cancer has spread. Tarlatamab is a bispecific antibody that works by targeting a protein on cancer cells (DLL3) and a protein on immune cells (CD3), aiming to help your immune system fight the cancer. Researchers want to see if tarlatamab can slow down the cancer's growth and spread, potentially helping people with this aggressive cancer live longer. The study plans to enroll 39 participants aged 18 or older. Success will be measured by how many people don't have their cancer worsen after 6 months of treatment. The current status of this study is unclear.
- Study design
- This is a Phase 2 interventional study, meaning all participants will receive tarlatamab. It plans to enroll 39 participants.
- What's involved
- You would undergo biopsies, blood sample collection, CT scans, and echocardiograms (ECHO). Your electronic health records would also be reviewed.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint measures progression-free survival up to 6 months from the start of treatment.
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NCT07423585
Tarlatamab for the Treatment of Extensive Stage Small-cell Lung Cancer
Recruiting
PHASE2Ages 18+InterventionalTreatmentAsrar AlahmadiInvestigator-initiated
~39 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:Biopsy ProcedureBiospecimen CollectionComputed TomographyEchocardiography TestElectronic Health Record ReviewMagnetic Resonance Imaging
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
6-month progression-free survival (PFS)
Measured over From the initiation of investigational therapy to progression, symptomatic deterioration, or death due to any cause, whichever comes first, assessed up to 6 months
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesOhio1
Study leadership
- Asrar AlAhmadi, MBBS · PRINCIPAL_INVESTIGATOR · Ohio State University Comprehensive Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
Patients with asymptomatic untreated brain metastases with no radiological evidence of vasogenic edema may be considered for inclusion after discussion with the sponsor
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)
Aspartate aminotransferase (AST) \< 3 x ULN (or \< 5 x ULN for subjects with liver involvement)
Alanine aminotransferase (ALT) \< 3 x ULN (or \< 5 x ULN for subjects with liver involvement)
Alkaline phosphatase (ALP) \< 3 x ULN (or \< 5 x ULN for subjects with liver involvement)
Albumin ≥ 2.5 g/dL
Patients with indwelling catheters (e.g., PleurX®) are allowed
Baseline oxygen saturation ≥ 90% on room air
Chronic obstructive pulmonary disease (COPD) patients on stable supplementary oxygen (O2) for at least 6 months may be considered for inclusion after discussion with the sponsor
Left ventricular ejection fraction (LVEF) ≥ 50%, no clinically significant pericardial effusion as determined by an ECHO or MUGA, and no clinically significant electrocardiogram (ECG) findings
As determined by the enrolling physician or protocol designee, the ability of the subject to understand and comply with study procedures for the entire length of the study
Availability of archival tissue, preferably a formalin-fixed, paraffin-embedded (FFPE) tumor tissue block (or ideally at least 15 newly cut unstained slides). For eligibility, only confirmation of archival tissue is needed. Verification of tumor burden in the biopsy is encouraged. For optimal biomarker results, tumor content should be \> 30% of total tissue area
Be willing to provide peripheral blood samples at specified time-points during the study
Exclusion
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
NOTE: Simple urinary tract infections and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with sponsor. Subjects requiring oral antibiotics who have been afebrile for \> 72 hours, have no leukocytosis, nor clinical signs of infection are eligible. Screening for chronic infectious conditions is not required unless otherwise noted as an exclusion criterion
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
Subject has known sensitivity and immediate hypersensitivity to any components of tarlatamab
Prior treatment for SCLC. Subjects with limited-stage SCLC (LS-SCLC) who progressed after 6 months from completing chemotherapy and radiation may be considered for inclusion after discussion with the sponsor
Palliative radiotherapy is allowed to non-target lesions, and must have been completed at least 7 days prior to the first dose of tarlatamab
Subjects with irreversible toxicity (defined as having been present and stable for \> 21 days) that, in the opinion of the treating physician, is not reasonably expected to be exacerbated by the investigational product may be included (e.g., neuropathy, alopecia, hearing loss, hormone deficiency requiring replacement therapy)
Subjects who received major surgery within 30 days. Subjects must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy
Subjects with known active autoimmune disease or immune deficiency that has required systemic treatment or steroids (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study
Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
Patients with controlled type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.
Physiologic doses of steroids are permitted
Subjects with a known history of solid organ transplantation
Subjects with evidence of interstitial lung disease or active, non-infectious pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. Subjects with history of radiation pneumonitis in the radiation field (fibrosis) are permitted
Subjects with known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Live and live attenuated vaccination are prohibited within 28 days prior to the first dose of tarlatamab treatment and for the duration of study. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination should be avoided during screening at least 14 days prior to the first day of tarlatamab treatment
Subjects of both genders of child-bearing potential who are not willing to practice an acceptable method(s) of effective birth control while on study, and through 60 days (for female subjects) or through 60 days (for male subjects) after receiving last dose of tarlatamab
Females who are pregnant or planning to become pregnant or breastfeeding or who plan to breastfeed while on study through 60 days after receiving the last dose of tarlatamab. Subjects who are willing to suspend breastfeeding prior to starting treatment with tarlatamab and do not intend to resume breastfeeding 60 days after receiving the last dose of tarlatamab can be enrolled.
Males who are unwilling to abstain from sperm donation while on study and through 60 days after receiving the last dose of tarlatamab
Symptomatic pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
Patients with indwelling catheters (e.g., PleurX) are allowed
Subjects with uncontrolled respiratory symptoms or concern about impending respiratory failure due to tumor compression requiring urgent intervention
Subjects with a history or current evidence of clinically significant disease, condition, therapeutic intervention, or laboratory abnormality that would pose a risk to subject safety and might confound the study evaluation, procedures or completion or may interfere with the subject's participation for the full duration of the trial, in the opinion of the treating investigator
What this trial measures
- 6-month progression-free survival (PFS)From the initiation of investigational therapy to progression, symptomatic deterioration, or death due to any cause, whichever comes first, assessed up to 6 months
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.
- Rapid progressive disease (PD) on tarlatamab rate probability (Interim analysis for futility monitoring)Within 4 weeks of starting tarlatamab
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.