TEMPUS Small Cell Lung Cancer OBSERVATIONAL STUDY (Sculptor)

NCT05257551 | Recruiting

• 1 other identifier: TP-CA-003
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Small Cell Lung Cancer

Keywords

Cancer; Oncology; Observational; Genomic Profiling; Precision medicine; SCLC; Small Cell Lung Cancer; NGS; Biomarkers; ctDNA; Transcriptomics; Extensive Stage

Outcome Measures

Primary Outcomes (2)

• To determine if tumor tissue transcriptional subtypes can be detected

  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

  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 Outcomes (2)

• 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

Other Outcomes (7)

• To identify biomarkers and mechanisms of progression

  Up to 4 years

• To determine feasibility of longitudinal collection of CTCs and ctDNA during first and second line therapy

  Up to 4 years

• To test feasibility of transcriptional subtyping from tissue collected from different metastatic sites compared to the primary site

  Up to 4 years

Study Arms (1)

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

Interventions

Observation OTHER

No intervention

Patients with Extensive Stage (ES) Small Cell Lung Cancer (SCLC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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 Medical Monitor)
• 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.
• ECOG performance status of 0-2 at time of enrollment
• 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)
• 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.
• 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).
• Willing and able to provide informed consent
• 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:
• 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:
• 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.
• 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.
• Mixed small cell and non-small cell histology
• 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)

Sponsors & Collaborators

• Tempus AI: lead
• AstraZeneca: collaborator

Study Sites (11)

Cancer and Blood Specialty Clinic

Los Alamitos, California, 90720, United States

WITHDRAWN

University of Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Illinois Cancer Care

Peoria, Illinois, 61615, United States

RECRUITING

Johns Hopkins University

Baltimore, Maryland, 21287, United States

RECRUITING

Englewood Health Medical Center

Englewood, New Jersey, 07631, United States

WITHDRAWN

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

RECRUITING

TriHealth Cancer Institute

Cincinnati, Ohio, 45220, United States

RECRUITING

Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

OhioHealth Research Institute

Columbus, Ohio, 43214, United States

WITHDRAWN

Oklahoma Cancer Specialists and Research Institutes

Tulsa, Oklahoma, 74146, United States

WITHDRAWN

Cancer Care Association of York

York, Pennsylvania, 17403, United States

RECRUITING

Related Publications (31)

• U.S. Food and Drug Administration. FDA approves lurbinectedin in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs for extensive-stage small cell lung cancer. FDA website. 2025

  BACKGROUND

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

  BACKGROUND

• 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.

  BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

• 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.

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

  BACKGROUND

• 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.

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• 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.

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  PMID: 32513672 BACKGROUND

• 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.

  PMID: 33482121 BACKGROUND

• Goldman JW, Dvorkin M, Chen Y, Reinmuth N, Hotta K, Trukhin D, Statsenko G, Hochmair MJ, Ozguroglu M, Ji JH, Garassino MC, Voitko O, Poltoratskiy A, Ponce S, Verderame F, Havel L, Bondarenko I, Kazarnowicz A, Losonczy G, Conev NV, Armstrong J, Byrne N, Thiyagarajah P, Jiang H, Paz-Ares L; CASPIAN investigators. Durvalumab, with or without tremelimumab, plus platinum-etoposide versus platinum-etoposide alone in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): updated results from a randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2021 Jan;22(1):51-65. doi: 10.1016/S1470-2045(20)30539-8. Epub 2020 Dec 4.

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• Horn L, Mansfield AS, Szczesna A, Havel L, Krzakowski M, Hochmair MJ, Huemer F, Losonczy G, Johnson ML, Nishio M, Reck M, Mok T, Lam S, Shames DS, Liu J, Ding B, Lopez-Chavez A, Kabbinavar F, Lin W, Sandler A, Liu SV; IMpower133 Study Group. First-Line Atezolizumab plus Chemotherapy in Extensive-Stage Small-Cell Lung Cancer. N Engl J Med. 2018 Dec 6;379(23):2220-2229. doi: 10.1056/NEJMoa1809064. Epub 2018 Sep 25.

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• Kalemkerian GP, Loo BW, Akerley W, Attia A, Bassetti M, Boumber Y, Decker R, Dobelbower MC, Dowlati A, Downey RJ, Florsheim C, Ganti AKP, Grecula JC, Gubens MA, Hann CL, Hayman JA, Heist RS, Koczywas M, Merritt RE, Mohindra N, Molina J, Moran CA, Morgensztern D, Pokharel S, Portnoy DC, Rhodes D, Rusthoven C, Sands J, Santana-Davila R, Williams CC, Hoffmann KG, Hughes M. NCCN Guidelines Insights: Small Cell Lung Cancer, Version 2.2018. J Natl Compr Canc Netw. 2018 Oct;16(10):1171-1182. doi: 10.6004/jnccn.2018.0079.

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• Liu MC, Oxnard GR, Klein EA, Swanton C, Seiden MV; CCGA Consortium. Sensitive and specific multi-cancer detection and localization using methylation signatures in cell-free DNA. Ann Oncol. 2020 Jun;31(6):745-759. doi: 10.1016/j.annonc.2020.02.011. Epub 2020 Mar 30.

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  BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood and tissue samples will be collected

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Neoplasms

Interventions

Observation

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Virginia Rhodes, MD

  Tempus AI, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sculptor Study

CONTACT

833-514-4187; sculptor-study@tempus.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: February 25, 2022
• Study Start: July 13, 2022
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

US (11)