Clinical trial NCT05257551: Tempus Sculptor Study: Small Cell Lung Cancer (SCLC) Observational Study
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Small Cell Lung Cancer
Keywords: Cancer
Oncology
Observational
Genomic Profiling
Precision medicine
SCLC
Small Cell Lung Cancer
NGS
Biomarkers
ctDNA
Transcriptomics
Lead sponsor: Tempus AI
Sponsor class: INDUSTRY
Collaborators: name: AstraZeneca
First posted: 2022-02-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This protocol targets patients with Small Cell Lung Cancer (SCLC)

Brief 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 criteria: The following are the inclusion criteria. Participants are eligible to be included in this study only if all the following criteria apply. The participant has/is:

* 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

Primary outcomes:
measure: To determine if tumor tissue transcriptional subtypes can be detected
timeFrame: Up to 4 years
measure: To characterize relationship between tissue transcriptional subtype and clinical outcomes
timeFrame: Up to 4 years
Secondary outcomes:
measure: To assess the potential for liquid biopsy in SCLC
timeFrame: Up to 4 years
measure: To test which tissue and sample variables confound gene expression subtypes
timeFrame: Up to 4 years
Other outcomes:
measure: To measure biomarkers of SCLC using the TEMPUS xT assay
timeFrame: Up to 4 years
measure: To identify biomarkers and mechanisms of progression
timeFrame: Up to 4 years
measure: To study progression free survival (PFS) and overall survival (OS)
timeFrame: Up to 4 years
Locations:
city: Los Alamitos
country: United States
facility: Cancer and Blood Specialty Clinic
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Peoria
country: United States
facility: Illinois Cancer Care
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Englewood
country: United States
facility: Englewood Health Medical Center
state: New Jersey
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Cincinnati
country: United States
facility: TriHealth Cancer Institute
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Columbus
country: United States
facility: OhioHealth Research Institute
state: Ohio
city: Tulsa
country: United States
facility: Oklahoma Cancer Specialists and Research Institutes
state: Oklahoma
city: York
country: United States
facility: Cancer Care Association of York
state: Pennsylvania
Study officials:
affiliation: Tempus AI, Inc.
name: Virginia Rhodes, MD
role: PRINCIPAL_INVESTIGATOR
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