SCLC Tarlatamab Blood Collection

NCT07468656 | Not Yet Recruiting

• 1 other identifier: Pro00119597
• Study Type: observational
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

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.

  Days 1, 8, and 15 of tarlatamab and after each interval scan for disease assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with small cell lung cancer (SCLC) who are eligible for treatment with tarlatamab

You may qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Laura Alder, MD

  Duke Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Alder, MD

CONTACT

+1 919 862 5400; laura.alder@duke.edu

Daniel Hess, MD, PhD

CONTACT

+1 919 684 8111; daniel.hess@duke.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 12, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 3, 2026

Record last verified: 2026-03