SCLC Tarlatamab Blood Collection
ConditionSmall-cell Lung Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDuke University
About this trial
The overall objective of this project is to prospectively collect blood samples throughout treatment with tarlatamab in patients with small cell lung cancer (SCLC). These samples will then be analyzed through a variety of assays to better characterize tarlatamab in the real-world setting.
The investigators will prospectively collect blood samples from 25 patients on days 1, 8, and 15 of tarlatamab treatment, as well as after each interval scan for disease monitoring. The investigators will also collect patient data including demographics and baseline characteristics, primary diagnosis, treatment history, and disease monitoring and progression.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pathologically documented small cell lung cancer (SCLC) or neuroendocrine tumor
Appropriate candidate for treatment with tarlatamab based on investigator discretion
Age > 18 years
Signed written informed consent including HIPAA according to institutional guidelines
Disqualifiers
Does not meet all inclusion criteria
Trial population
Adult patients with small cell lung cancer (SCLC) who are eligible for treatment with tarlatamab
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Number of blood samples collected to better characterize tarlatamab in real-world setting
Studies to better understand tarlatamab may include, but are not limited to, the following: 1) predictors of response to treatment with tarlatamab, 2) identification of predictive biomarkers for the development of cytokine release syndrome (CRS) and/or immune effector cell-associated neurotoxicity syndrome (ICANS), 3) characterization of the immune cell environment induced by tarlatamab, 4) identification of resistance mechanisms to tarlatamab treatment, and 5) development of potential translational correlates.
Time frame
Days 1, 8, and 15 of tarlatamab and after each interval scan for disease assessmentLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: