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
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.
• 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