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Observational study on small cell lung cancer patients receiving standard care

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

Observational Tempus AI · NCT05257551

This study looks at small cell lung cancer patients receiving their usual treatment to see how their tumor and blood samples can help us understand the disease better and improve future treatments.

Quick facts

Study typeObservational
Enrollment200 (estimated)
Ages18 Years and up
SexAll
SponsorTempus AI Industry-sponsored
Drugs / interventionsatezolizumab, durvalumab, immunotherapy, radiation
Locations11 sites (Los Alamitos, California and 10 other locations)
Trial IDNCT05257551 on ClinicalTrials.gov

What this trial studies

This observational study evaluates participants diagnosed with small cell lung cancer (SCLC) who will undergo diagnostic and post-progression tumor tissue profiling, as well as plasma ctDNA biomarker profiling, while receiving their standard of care therapy. The study aims to gather data on the genomic characteristics of SCLC to enhance understanding of the disease and inform future treatment strategies. Participants will provide tumor samples and undergo disease surveillance as part of the study protocol.

Who should consider this trial

Good fit: Ideal candidates are adults with histologically confirmed extensive stage small cell lung cancer who are starting first-line therapy with etoposide, carboplatin, and a PD-L1 inhibitor.

Not a fit: Patients with a history of prior systemic treatment for small cell lung cancer or those with non-small cell lung cancer will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved precision medicine approaches for treating small cell lung cancer.

How similar studies have performed: Other studies utilizing genomic profiling in cancer treatment have shown promise, indicating that this approach may yield valuable insights.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Los Alamitos, California and 10 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Small Cell Lung CancerCancerOncologyObservationalGenomic ProfilingPrecision medicineSCLCNGS
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.