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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Small Cell Lung Cancer

Intervention / Treatment
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* Other: Observation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 or 1 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 Exclusion Criteria: History of prior systemic treatment of SCLC History of radiotherapy or planned radiotherapy to all measurable disease foci Prior diagnosis of non-small cell lung cancer 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Small Cell Lung Cancer (SCLC)<br>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. | Other: Observation<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if tumor tissue transcriptional subtypes can be detected | To determine prospectively if SCLC tumor tissue transcriptional subtypes can be detected by Tempus|xT RNAseq | Up to 4 years | 
| To characterize relationship between tissue transcriptional subtype and clinical outcomes | To characterize the relationship between tissue transcriptional subtype and clinical outcomes for EP+PDL1-i therapy based on collection of longitudinal information from medical records | Up to 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the potential for liquid biopsy in SCLC | To use blood based assays to assess the complementarity of circulating biomarkers to tissue based methods | Up to 4 years | 
| To test which tissue and sample variables confound gene expression subtypes | To measure how variable transcriptional measurements are across tissue characteristics such as site of biopsy and type of biopsy | Up to 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Oncology, Observational, Genomic Profiling, Precision medicine, SCLC, Small Cell Lung Cancer, NGS, Biomarkers, ctDNA, Transcriptomics