Health TrialsbyHealthPanel

Tempus Small Cell Lung Cancer Observational Study (Sculptor)

ConditionSmall Cell Lung Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTempus AI

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial population

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

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Observation

    Other intervention

    No intervention

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Patients with Extensive Stage (ES) Small Cell Lung Cancer (SCLC)1 intervention

Trial outcomes

Primary outcomes

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

Time frame
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

Time frame
Up to 4 years

Secondary outcomes

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

Time frame
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

Time frame
Up to 4 years

Other outcomes

1

To identify biomarkers and mechanisms of progression

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

Time frame
Up to 4 years
2

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

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

Time frame
Up to 4 years
3

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

Time frame
Up to 4 years
4

To describe specific methylation biomarkers of SCLC subtypes

Time frame
Up to 4 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tempus AI

Lead sponsor

AstraZeneca

Collaborator

Source ClinicalTrials.gov
Apply now