Tempus Sculptor Study: Small Cell Lung Cancer (SCLC) Observational Study
- Conditions
- Small Cell Lung Cancer
- Registration Number
- NCT05257551
- Lead Sponsor
- Tempus AI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
The following are the inclusion criteria. Participants are eligible to be included in<br>this study only if all the following criteria apply. The participant has/is:<br><br> - Histologically confirmed small cell lung cancer diagnosis<br><br> - Diagnosis made with excisional or core needle biopsy specimen (fine needle aspirate<br> may be permitted with approval from the PI)<br><br> - Subjects must submit fresh or archived FFPE tumor sample to the central laboratory<br><br> - ECOG performance status of 0-2 at time of enrollment<br><br> - Planned extensive stage first-line therapy of etoposide plus carboplatin plus PD-L1<br> inhibitor (atezolizumab or durvalumab)<br><br> - Extensive stage disease at time of diagnosis<br><br> - Willing and able to provide informed consent<br><br> - Radiotherapy is permitted as long as there is measurable disease outside of the<br> radiotherapy port<br><br>Participants will be excluded from the study if any of the following criteria apply. The<br>participant has/is:<br><br> - History of prior systemic treatment of SCLC<br><br> - Prior diagnosis of non-small cell lung cancer is excluded if the cancer is diagnosed<br> < 3 years prior to study entry. Additionally, the participant must be off all<br> therapy for the NSCLC at the time of study entry.<br><br> - Mixed small cell and non-small cell histology<br><br> - Suspected metastatic cancer from other sites (i.e., those without a known or<br> suspected lung primary diagnosis)<br><br> - Not willing to have additional blood samples collected
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine if tumor tissue transcriptional subtypes can be detected;To characterize relationship between tissue transcriptional subtype and clinical outcomes
- Secondary Outcome Measures
Name Time Method To assess the potential for liquid biopsy in SCLC;To test which tissue and sample variables confound gene expression subtypes