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

Launched by TEMPUS AI · Feb 17, 2022

Keywords

ClinConnect Summary

The Tempus Sculptor Study is a research project focused on understanding small cell lung cancer (SCLC) by looking at tumor samples and blood tests from patients receiving standard treatments. This study is not testing a new drug but is collecting information about how the disease behaves and how patients respond to treatment. Participants will provide tumor and blood samples to help researchers identify important markers that could guide future treatments.

To be part of this study, participants must have a confirmed diagnosis of extensive stage small cell lung cancer and be starting a specific combination of therapies, including a chemotherapy drug and a type of immunotherapy. Participants should be between the ages of 65 and 74 and must be able to give consent to take part. Throughout the study, participants can expect to have their health monitored regularly, and they will be asked for additional blood samples. This research aims to improve our understanding of SCLC and could help develop better treatments in the future.

Gender

ALL

Eligibility criteria

• 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