Status:
RECRUITING
Tempus Sculptor Study: Small Cell Lung Cancer (SCLC) Observational Study
Lead Sponsor:
Tempus AI
Collaborating Sponsors:
AstraZeneca
Conditions:
Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
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 profil...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 13 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05257551
Start Date
July 13 2022
End Date
March 1 2026
Last Update
May 6 2025
Active Locations (11)
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1
Cancer and Blood Specialty Clinic
Los Alamitos, California, United States, 90720
2
University of Colorado
Aurora, Colorado, United States, 80045
3
Illinois Cancer Care
Peoria, Illinois, United States, 61615
4
Johns Hopkins University
Baltimore, Maryland, United States, 21287