Small-cell Lung CancerNCT07468656
SCLC Tarlatamab Blood Collection
An observational study of Small-cell Lung Cancer, run by Duke University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small-cell Lung Cancer
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with small cell lung cancer (SCLC) who are eligible for treatment with tarlatamab
Who may be able to join
- 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
Who cannot join
- Does not meet all inclusion criteria
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Analysis of Blood Samples in Small Cell Lung Cancer Patients Treated With Tarlatamab
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.
- Conditions
- Small-cell Lung Cancer
- Medical subject headings
- Small Cell Lung Carcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Days 1, 8, and 15 of tarlatamab and after each interval scan for disease assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small-cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Alder, MD, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07468656
- Sponsor's protocol ID
- Pro00119597
- Status last verified
- Aug 2026
- First submitted
- 9 Mar 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Blood Samples in Small Cell Lung Cancer Patients Treated With Tarlatamab
- ClinicalTrials.gov ID
- NCT07468656
- Acronym / sponsor ID
- Pro00119597
- Conditions
- Small-cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with small cell lung cancer (SCLC) who are eligible for treatment with tarlatamab
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Does not meet all inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of blood samples collected to better characterize tarlatamab in real-world setting
Time frame: Days 1, 8, and 15 of tarlatamab and after each interval scan for disease assessment
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura Alder, MD principal investigator
Duke Health
Questions about this trial
What is this clinical trial studying?
An observational study of Small-cell Lung Cancer, run by Duke University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Alder, MD (+1 919 862 5400, laura.alder@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of blood samples collected to better characterize tarlatamab in real-world setting (time frame: Days 1, 8, and 15 of tarlatamab and after each interval scan for disease assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.