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NCT Number: NCT07468656

SCLC Tarlatamab Blood Collection

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.

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Key information

Conditions

Small-cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Does not meet all inclusion criteria

Treatment and study plan

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Hess, MD, PhD

CONTACT

[email protected]

+1 919 684 8111

Laura Alder, MD

CONTACT

[email protected]

+1 919 862 5400

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Analysis of Blood Samples in Small Cell Lung Cancer Patients Treated With Tarlatamab

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 12, 2026
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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