RecruitingNCT05257551

Tempus Sculptor Study: Small Cell Lung Cancer (SCLC) Observational Study

Tempus Small Cell Lung Cancer Observational Study (Sculptor): A Tissue and Longitudinal Circulating Tumor DNA (ctDNA) Biomarker Profiling Study of Patients With Small Cell Lung Cancer (SCLC) Using Comprehensive Next-Generation Sequencing (NGS) Assays


Sponsor

Tempus AI

Enrollment

50 participants

Start Date

Jul 13, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

The study is a non-interventional evaluation of participants with SCLC who will receive diagnostic and (where possible) post-progression tumor tissue profiling, alongside plasma ctDNA biomarker profiling in addition to their standard of care therapy and disease surveillance.


Eligibility

Min Age: 18 Years

Inclusion Criteria14

  • Histologically confirmed small cell lung cancer diagnosis
  • Diagnosis made with excisional or core needle biopsy specimen (fine needle aspirate may be permitted with approval from the PI)
  • Subjects must submit fresh or archived FFPE tumor sample to the central laboratory
  • ECOG performance status of 0-2 at time of enrollment
  • Planned extensive stage first-line therapy of etoposide plus carboplatin plus PD-L1 inhibitor (atezolizumab or durvalumab)
  • Extensive stage disease at time of diagnosis
  • Willing and able to provide informed consent
  • Radiotherapy is permitted as long as there is measurable disease outside of the radiotherapy port
  • Participants will be excluded from the study if any of the following criteria apply. The participant has/is:
  • History of prior systemic treatment of SCLC
  • Prior diagnosis of non-small cell lung cancer is excluded if the cancer is diagnosed \< 3 years prior to study entry. Additionally, the participant must be off all therapy for the NSCLC at the time of study entry.
  • Mixed small cell and non-small cell histology
  • Suspected metastatic cancer from other sites (i.e., those without a known or suspected lung primary diagnosis)
  • Not willing to have additional blood samples collected

Interventions

OTHERObservation

No intervention


Locations(11)

Cancer and Blood Specialty Clinic

Los Alamitos, California, United States

University of Colorado

Aurora, Colorado, United States

Illinois Cancer Care

Peoria, Illinois, United States

Johns Hopkins University

Baltimore, Maryland, United States

Englewood Health Medical Center

Englewood, New Jersey, United States

University of North Carolina

Chapel Hill, North Carolina, United States

TriHealth Cancer Institute

Cincinnati, Ohio, United States

Ohio State University

Columbus, Ohio, United States

OhioHealth Research Institute

Columbus, Ohio, United States

Oklahoma Cancer Specialists and Research Institutes

Tulsa, Oklahoma, United States

Cancer Care Association of York

York, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05257551


Related Trials