TEMPUS Small Cell Lung Cancer OBSERVATIONAL STUDY (Sculptor)

June 10, 2026 updated by: Tempus AI

TEMPUS SCLC OBSERVATIONAL STUDY: 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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Alamitos, California, United States, 90720
        • Withdrawn
        • Cancer and Blood Specialty Clinic
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado
        • Principal Investigator:
          • Tejas Patil, MD
        • Contact:
    • Illinois
      • Peoria, Illinois, United States, 61615
        • Recruiting
        • Illinois Cancer Care
        • Principal Investigator:
          • Mohammad (Fahad) Asad, MD
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins University
        • Principal Investigator:
          • Lonny Yarmus, MD
        • Contact:
    • New Jersey
      • Englewood, New Jersey, United States, 07631
        • Withdrawn
        • Englewood Health Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • University of North Carolina
        • Principal Investigator:
          • Jason Akulian, MD
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • Recruiting
        • TriHealth Cancer Institute
        • Principal Investigator:
          • James Maher, MD
        • Contact:
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University
        • Principal Investigator:
          • Asrar Alahmadi
        • Contact:
      • Columbus, Ohio, United States, 43214
        • Withdrawn
        • OhioHealth Research Institute
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74146
        • Withdrawn
        • Oklahoma Cancer Specialists and Research Institutes
    • Pennsylvania
      • York, Pennsylvania, United States, 17403
        • Recruiting
        • Cancer Care Association of York
        • Contact:
          • Jennifer Stough
        • Contact:
          • Phone Number: 717-741-9229
        • Principal Investigator:
          • Chanh Huynh, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This protocol targets patients with Extensive Stage (ES) Small Cell Lung Cancer (SCLC) receiving first-line and second-line standard of care therapy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with Extensive Stage (ES) Small Cell Lung Cancer (SCLC)
This protocol will include participants with extensive stage small cell lung cancer receiving standard of care therapy in first and second line with tissue collected from the primary lung tumor or metastatic sites.
Other: Observation
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine if tumor tissue transcriptional subtypes can be detected
Time Frame: Up to 4 years
To determine prospectively if SCLC tumor tissue transcriptional subtypes can be detected by RNAseq
Up to 4 years
To characterize relationship between tissue transcriptional subtype and clinical outcomes
Time Frame: Up to 4 years
To characterize the relationship between tissue transcriptional subtype and clinical outcomes for first and second line based on collection of longitudinal information from medical records
Up to 4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: Up to 4 years
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
Time Frame: Up to 4 years
To longitudinally evaluate the relationship between initial molecular SCLC subtypes (e.g., SCLC-A, SCLC-N, SCLC-I) and the subsequent development of therapeutic resistance, identifying the specific genomic and cellular mechanisms (e.g., non-NE phenotypic emergence) that occur during clinical progression on first- and second-line treatments
Up to 4 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
To identify biomarkers and mechanisms of progression
Time Frame: Up to 4 years
To test the feasibility of longitudinally detecting transcriptional SCLC subtype related biomarkers from ctDNA methylation and to correlate these results with other longitudinal liquid biopsy findings (ctDNA and CTCs) during therapy to assess if changes are detectable prior to progression
Up to 4 years
To determine feasibility of longitudinal collection of CTCs and ctDNA during first and second line therapy
Time Frame: Up to 4 years
To determine the feasibility of longitudinal collection and multiomic analysis of CTCs and ctDNA during first-line and second-line therapy in SCLC patients to define the evolution of transcriptional subtypes over longitudinal collections with the pressure of therapy across multiple lines of therapy
Up to 4 years
To test feasibility of transcriptional subtyping from tissue collected from different metastatic sites compared to the primary site
Time Frame: Up to 4 years
Up to 4 years
To describe specific methylation biomarkers of SCLC subtypes
Time Frame: Up to 4 years
Up to 4 years
To correlate methylation biomarkers with clinical outcomes real-world progression free-survival (rwPFS) and real-world overall survival (rwOS)
Time Frame: Up to 4 years
Up to 4 years
To determine the feasibility of developing an algorithmic method to detect transcriptional SCLC subtype from ctDNA methylation
Time Frame: Up to 4 years
Up to 4 years
To identify specific genomic and cellular mechanisms of acquired therapeutic resistance (e.g., subtype switching, emergence of non-NE phenotypes) that occur during first and second-line therapy
Time Frame: Up to 4 years
Up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tempus AI

Collaborators

AstraZeneca

Investigators

  • Principal Investigator: Virginia Rhodes, MD, Tempus AI, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2022

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

January 20, 2022

First Submitted That Met QC Criteria

February 17, 2022

First Posted (Actual)

February 25, 2022

Study Record Updates

Last Update Posted (Actual)

June 12, 2026

Last Update Submitted That Met QC Criteria

June 10, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TP-CA-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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