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

Plain English Summary

TEMPUS Small Cell Lung Cancer OBSERVATIONAL STUDY (Sculptor) is a Not Applicable clinical trial sponsored by Tempus AI studying Small Cell Lung Cancer. This study looks at tumor tissue and blood samples from patients with extensive stage Small Cell Lung Cancer (SCLC). It is for patients diagnosed with SCLC who are receiving standard treatments. Participation involves providing tumor tissue and blood samples for advanced genetic testing. There are no alternative treatments offered within this study; it is observational. The trial aims to enroll 200 participants.

Official Summary

The study is a non-interventional evaluation of participants with extensive stage (ES) SCLC who will receive diagnostic and (where possible) post-progression tumor tissue profiling, alongside plasma ctDNA and CTC biomarker profiling during standard of care therapy in both first and second line treatment.

Who Can Participate

Here is what you need to know about eligibility for this trial. Patients with a confirmed diagnosis of Small Cell Lung Cancer. Must have tissue samples available from a biopsy (needle or surgical). Patients must have an ECOG performance status of 0-2 (meaning they are relatively active and can do light work). Patients receiving first-line treatment must be planned for etoposide plus platinum with a PD-L1 inhibitor. Patients receiving second-line treatment must have completed standard first-line therapy. This trial is studying Small Cell Lung Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcomes measure whether the study can identify different genetic subtypes within SCLC tumors and how these subtypes relate to how patients do over time. The specific primary outcome measures are: To determine if tumor tissue transcriptional subtypes can be detected (Up to 4 years); To characterize relationship between tissue transcriptional subtype and clinical outcomes (Up to 4 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial matters because it aims to understand the genetic makeup of SCLC tumors and how it relates to treatment response, potentially leading to more personalized therapies for this aggressive canc This research targets Small Cell Lung Cancer, where improved treatment options are needed.

Investor Insight

This observational study by Tempus AI focuses on biomarker profiling in SCLC, a challenging cancer market, aiming to identify patterns that could inform future targeted therapies and potentially impro

Is This Trial Right for Me?

Ask your doctor if your tumor type and stage are suitable for this study. Understand that this study involves collecting extra tissue and blood samples for detailed genetic analysis. Your day-to-day activities will likely remain the same as you continue with your standard cancer treatment. This trial is currently recruiting participants. The trial is being conducted at 11 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: OBSERVATIONAL
• Enrollment: 200 participants

Interventions

• OTHER: Observation — No intervention

Primary Outcomes

• To determine if tumor tissue transcriptional subtypes can be detected (Up to 4 years)
• To characterize relationship between tissue transcriptional subtype and clinical outcomes (Up to 4 years)

Secondary Outcomes

• To characterize the relationship between longitudinal ctDNA methylation and CTC results with clinical outcomes for first and second line therapy based on collection of longitudinal information from medical records (Up to 4 years)
• To evaluate the relationship between initial molecular SCLC subtypes (e.g., SCLC-A, SCLC-N, SCLC-I) and the subsequent development of therapeutic resistance (Up to 4 years)

Full 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:

1. Histologically confirmed small cell lung cancer diagnosis
2. Diagnosis made with excisional or core needle biopsy specimen (fine needle aspirate may be permitted with approval from the Medical Monitor)
3. Subjects must submit tumor sample per the laboratory manual, defined as follows: 1L Cohort - Tissue obtained prior to the initiation of 1L therapy; 2L Cohort - Tissue obtained prior to the initiation of 1L therapy and/or a standard of care re-biopsy prior to the start of 2L therapy, if performed.
4. ECOG performance status of 0-2 at time of enrollment
5. For participants entering prior to first line therapy, planned extensive stage first-line therapy of etoposide plus platinum plus PD-L1 inhibitor (atezolizumab or durvalumab)
6. For participants entering post completion of standard of care first line prior to second line therapy, completion of an EP+CPI with or without maintenance therapy. Note: Participants who received 1L therapy that is not standard of care i.e., investigational therapy, are not eligible.
7. Extensive stage disease at time of diagnosis according to NCCN definition: Extensive Stage Small Cell Lung Cancer (SCLC) as either Stage IV disease (any T, any N, with M1a/b/c) or T3-4 disease due to multiple lung nodules that are too extensive or have a tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan (NCCN version 2.2026-September 16, 2025).
8. Willing and able to provide informed consent
9. Palliative radiotherapy is permitted as long as there is measurable disease outside of the radiotherapy port with which to assess response to therapy delivered

Participants will be excluded from the study if any of the following criteria apply. The participant has/is:

1. Patients with a secondary malignancy must have been both diagnosed \> 3 years from the lung cancer of interest and have completed all therapy for that malignancy \> 3 years prior to diagnosis of the lung cancer of interest, with the exception of the following:

   1. Patients with superficial basal cell carcinoma of low-risk histology per NCCN Guidelines (Low-risk histologic subtypes include nodular, superficial, and other non-aggressive growth patterns such as keratotic, infundibulocystic, and fibroepithelioma of Pinkus) and low-risk for recurrence per NCCN Guidelines (location on trunk or extremities, size \< 2 cm, primary (not recurrent), with well-defined borders) can be included even if they are diagnosed \< 3 years from the lung cancer of interest.
   2. Patients with superficial squamous cell carcinoma of low-risk pathology per NCCN Guidelines (verrucous, keratoacanthomatous) and low-risk for recurrence per NCCN Guidelines (located on trunk or extremities; ≤ 2 cm in size; primary lesion (vs. recurrent); well to moderately differentiated; \< 2 mm thick and no invasion beyond subcutaneous fat; negative for perineural invasion; and negative for lymphatic or vascular involvement) can be included even if they are diagnosed \< 3 years from the lung cancer of interest.
2. Mixed small cell and non-small cell histology
3. Small cell cancers of origin in other organs or suspected metastatic cancer from other sites (i.e., those without a known or suspected lung primary diagnosis)
4. Large Cell Neuroendocrine cancers
5. Carcinoids or atypical carcinoid tumors
6. Transformed small cell lung cancer emerging in the setting of targeted therapy for NSCLC
7. Treated with an investigational agent of another immunotherapy class (i.e., non PD-1 or PD-L1 inhibitor)
8. Not willing to have additional blood samples collected

Trial Locations

• Cancer and Blood Specialty Clinic, Los Alamitos, California, United States
• University of Colorado, Aurora, Colorado, United States
• Illinois Cancer Care, Peoria, Illinois, United States
• Johns Hopkins University, Baltimore, Maryland, United States
• Englewood Health Medical Center, Englewood, New Jersey, United States
• University of North Carolina, Chapel Hill, North Carolina, United States
• TriHealth Cancer Institute, Cincinnati, Ohio, United States
• Ohio State University, Columbus, Ohio, United States
• OhioHealth Research Institute, Columbus, Ohio, United States
• Oklahoma Cancer Specialists and Research Institutes, Tulsa, Oklahoma, United States
• ...and 1 more locations

Frequently Asked Questions

Related Conditions

• Small Cell Lung Cancer
• Extensive Stage Small Cell Lung Cancer
• Lung Cancer
• Oncology
• Biomarker Profiling
• Next-Generation Sequencing
• Liquid Biopsy
• Tumor Genetics
• Cancer Research
• Clinical Trials

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