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Small Cell Lung CancerNCT05257551

Tempus Small Cell Lung Cancer Observational Study (Sculptor)

An observational study of Small Cell Lung Cancer, run by Tempus AI at 11 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Cell Lung Cancer
What is being tested?
Observation
How many people
200 participants
Where
11 sitesUnited States
Study dates
13 Jul 2022to Mar 2029
How long will I take part?
3 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

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:
  2. 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.
  3. 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.
  4. Mixed small cell and non-small cell histology
  5. 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)
  6. Large Cell Neuroendocrine cancers
  7. Carcinoids or atypical carcinoid tumors
  8. Transformed small cell lung cancer emerging in the setting of targeted therapy for NSCLC
  9. Treated with an investigational agent of another immunotherapy class (i.e., non PD-1 or PD-L1 inhibitor)
  10. Not willing to have additional blood samples collected

Trial locations and contacts

11 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Sculptor Study contact

833-514-4187

sculptor-study@tempus.com

11 sites in 1 country

United States11 sites, 7 recruiting

  • University of Colorado

    Aurora, Colorado, 80045

    Emily Adam, 303-724-9682, EMILY.ADAM@cuanschutz.edu

    Tejas Patil, MD

    Recruiting

  • Johns Hopkins University

    Baltimore, Maryland, 21287

    Cheryl Pai, 410-614-1926, cpai3@jhu.edu

    Lonny Yarmus, MD

    Recruiting

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

    Ashley Delgado, 984-520-7329, ashley_delgado@med.unc.edu

    Jason Akulian, MD

    Recruiting

  • TriHealth Cancer Institute

    Cincinnati, Ohio, 45220

    Patrick Newbury, 513 865 5249, Patrick_Newbury@trihealth.com

    James Maher, MD

    Recruiting

  • Ohio State University

    Columbus, Ohio, 43210

    Nicole Bullock, 614-366-6489, nicole.bullock@osumc.edu

    Asrar Alahmadi

    Recruiting

  • OhioHealth Research Institute

    Columbus, Ohio, 43214

    Withdrawn

  • Englewood Health Medical Center

    Englewood, New Jersey, 07631

    Withdrawn

  • Cancer and Blood Specialty Clinic

    Los Alamitos, California, 90720

    Withdrawn

  • Illinois Cancer Care

    Peoria, Illinois, 61615

    Beth Heilman, 309-243-3617, bheilman@illinoiscancercare.com

    Mohammad (Fahad) Asad, MD

    Recruiting

  • Oklahoma Cancer Specialists and Research Institutes

    Tulsa, Oklahoma, 74146

    Withdrawn

  • Cancer Care Association of York

    York, Pennsylvania, 17403

    Jennifer Stough

    717-741-9229

    Recruiting

Other trials in United States

About this study

Official title: 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.

Being tested
Observation
Keywords
Cancer, Oncology, Observational, Genomic Profiling, Precision medicine, SCLC, Small Cell Lung Cancer, NGS, Biomarkers, ctDNA, Transcriptomics, Extensive Stage
Medical subject headings
Small Cell Lung Carcinoma, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ObservationOther

    No intervention

Study groups in NCT05257551
Study groupRoleWhat they receive
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.
Receives: Other: Observation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To determine if tumor tissue transcriptional subtypes can be detected

    To determine prospectively if SCLC tumor tissue transcriptional subtypes can be detected by RNAseq

    Measured: Up to 4 years

  2. To characterize relationship between tissue transcriptional subtype and clinical outcomes

    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

    Measured: Up to 4 years

Secondary outcomes (2)

  1. 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

    Measured: Up to 4 years

  2. To evaluate the relationship between initial molecular SCLC subtypes (e.g., SCLC-A, SCLC-N, SCLC-I) and the subsequent development of therapeutic resistance

    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

    Measured: Up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2022
  2. Study start13 Jul 2022
  3. Primary completionMar 2029 (estimated)
  4. Study completionMar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
200 participants (estimated)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT05257551
Sponsor's protocol ID
TP-CA-003
Status last verified
Jun 2026
First submitted
20 Jan 2022
Last updated
15 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Kepp O, Kroemer G. FDA approves lurbinectedin in combination with atezolizumab for extensive-stage small cell lung cancer. Oncoimmunology. 2025 Dec 31;14(1):2584898. doi: 10.1080/2162402X.2025.2584898. Epub 2025 Nov 18.

    PubMed 41254986

  • U.S. Food and Drug Administration. FDA grants accelerated approval to lurbinectedin for metastatic small cell lung cancer. FDA website. 2020

  • Saunders LR, et al. A highly efficacious bispecific antibody targeting DLL3 and CD3 in small cell lung cancer. Sci Transl Med. 2015;7(312):312ra179.

  • Rudin CM. Second-line tarlatamab shows improved survival over chemotherapy in previously treated SCLC. ASCO Daily News. 2025 Jun 2.

  • Rudin CM, et al. Molecular mechanisms of plasticity in small-cell lung cancer. Cold Spring Harb Perspect Med. 2019;9(12):a035252.

  • Paz-Ares L, Borghaei H, Liu SV, Peters S, Herbst RS, Stencel K, Majem M, Sendur MAN, Czyzewicz G, Caro RB, Lee KH, Johnson ML, Karadurmus N, Grohe C, Baka S, Csoszi T, Ahn JS, Califano R, Yang TY, Kemal Y, Ballinger M, Cuchelkar V, Graupner V, Lin YC, Chakrabarti D, Bhatt K, Cai G, Iannone R, Reck M; IMforte investigators. Efficacy and safety of first-line maintenance therapy with lurbinectedin plus atezolizumab in extensive-stage small-cell lung cancer (IMforte): a randomised, multicentre, open-label, phase 3 trial. Lancet. 2025 Jun 14;405(10495):2129-2143. doi: 10.1016/S0140-6736(25)01011-6. Epub 2025 Jun 2.

    PubMed 40473449

  • Paz-Ares L, et al. Tarlatamab in previously treated small-cell lung cancer: a phase 2, open-label, multicentre study (DeLLphi-301). Lancet. 2024.

  • Hanvesakul R, Rengarajan B, Naveh N, Boccuti A, Park JE, Adeyemi A, Caisip C, Jansen JP, Wilson FR. Indirect treatment comparison of lurbinectedin versus other second-line treatments for small-cell lung cancer. J Comp Eff Res. 2023 May;12(5):e220098. doi: 10.57264/cer-2022-0098. Epub 2023 Apr 20.

    PubMed 37079341

  • Abbosh C, et al. Sequencing of tumor-informed circulating tumor DNA to monitor disease in patients with small cell lung cancer. Sci Transl Med. 2021.

  • Chan JM, Quintanal-Villalonga A, Gao VR, Xie Y, Allaj V, Chaudhary O, Masilionis I, Egger J, Chow A, Walle T, Mattar M, Yarlagadda DVK, Wang JL, Uddin F, Offin M, Ciampricotti M, Qeriqi B, Bahr A, de Stanchina E, Bhanot UK, Lai WV, Bott MJ, Jones DR, Ruiz A, Baine MK, Li Y, Rekhtman N, Poirier JT, Nawy T, Sen T, Mazutis L, Hollmann TJ, Pe'er D, Rudin CM. Signatures of plasticity, metastasis, and immunosuppression in an atlas of human small cell lung cancer. Cancer Cell. 2021 Nov 8;39(11):1479-1496.e18. doi: 10.1016/j.ccell.2021.09.008. Epub 2021 Oct 14.

    PubMed 34653364

  • Byers LA, Rudin CM. Small cell lung cancer: where do we go from here? Cancer. 2015 Mar 1;121(5):664-72. doi: 10.1002/cncr.29098. Epub 2014 Oct 21.

    PubMed 25336398

  • Borromeo MD, Savage TK, Kollipara RK, He M, Augustyn A, Osborne JK, Girard L, Minna JD, Gazdar AF, Cobb MH, Johnson JE. ASCL1 and NEUROD1 Reveal Heterogeneity in Pulmonary Neuroendocrine Tumors and Regulate Distinct Genetic Programs. Cell Rep. 2016 Aug 2;16(5):1259-1272. doi: 10.1016/j.celrep.2016.06.081. Epub 2016 Jul 21.

    PubMed 27452466

  • Crowley E, Di Nicolantonio F, Loupakis F, Bardelli A. Liquid biopsy: monitoring cancer-genetics in the blood. Nat Rev Clin Oncol. 2013 Aug;10(8):472-84. doi: 10.1038/nrclinonc.2013.110. Epub 2013 Jul 9.

    PubMed 23836314

  • Drapkin BJ, Rudin CM. Advances in Small-Cell Lung Cancer (SCLC) Translational Research. Cold Spring Harb Perspect Med. 2021 Apr 1;11(4):a038240. doi: 10.1101/cshperspect.a038240.

    PubMed 32513672

  • Gay CM, Stewart CA, Park EM, Diao L, Groves SM, Heeke S, Nabet BY, Fujimoto J, Solis LM, Lu W, Xi Y, Cardnell RJ, Wang Q, Fabbri G, Cargill KR, Vokes NI, Ramkumar K, Zhang B, Della Corte CM, Robson P, Swisher SG, Roth JA, Glisson BS, Shames DS, Wistuba II, Wang J, Quaranta V, Minna J, Heymach JV, Byers LA. Patterns of transcription factor programs and immune pathway activation define four major subtypes of SCLC with distinct therapeutic vulnerabilities. Cancer Cell. 2021 Mar 8;39(3):346-360.e7. doi: 10.1016/j.ccell.2020.12.014. Epub 2021 Jan 21.

    PubMed 33482121

Questions about this trial

What is this clinical trial studying?

An observational study of Small Cell Lung Cancer, run by Tempus AI at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sculptor Study (833-514-4187, sculptor-study@tempus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine if tumor tissue transcriptional subtypes can be detected (time frame: Up to 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05257551, which also lists 31 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026; AzTrials last refreshed its copy on 31 Oct 2026.

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