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

Status: Recruiting
Location: See all (11) locations...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Cancer and Blood Specialty Clinic
WITHDRAWN
Los Alamitos
Colorado
University of Colorado
RECRUITING
Aurora
Illinois
Illinois Cancer Care
RECRUITING
Peoria
Maryland
Johns Hopkins University
RECRUITING
Baltimore
North Carolina
University of North Carolina
RECRUITING
Chapel Hill
New Jersey
Englewood Health Medical Center
WITHDRAWN
Englewood
Ohio
TriHealth Cancer Institute
RECRUITING
Cincinnati
Ohio State University
RECRUITING
Columbus
OhioHealth Research Institute
WITHDRAWN
Columbus
Oklahoma
Oklahoma Cancer Specialists and Research Institutes
WITHDRAWN
Tulsa
Pennsylvania
Cancer Care Association of York
RECRUITING
York
Contact Information
Primary
Sculptor Study
sculptor-study@tempus.com
833-514-4187
Time Frame
Start Date: 2022-07-13
Estimated Completion Date: 2026-03
Participants
Target number of participants: 50
Treatments
Patients with Small Cell Lung Cancer (SCLC)
This protocol will include participants with newly diagnosed extensive stage (stage IV) small cell lung cancer with tissue collected from the primary lung tumor, or metastatic sites outside of the liver or biliary system.
Sponsors
Leads: Tempus AI
Collaborators: AstraZeneca

This content was sourced from clinicaltrials.gov