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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05257551
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