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Patients with Small Cell Lung Cancer (SCLC) for Small Cell Lung Cancer
N/A
Recruiting
Led By Virginia Rhodes, MD
Research Sponsored by Tempus AI
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
Summary
The study is a non-interventional evaluation of participants with SCLC who will receive diagnostic and (where possible) post-progression tumor tissue profiling, alongside plasma ctDNA biomarker profiling in addition to their standard of care therapy and disease surveillance.
Eligible Conditions
- Small Cell Lung Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To characterize relationship between tissue transcriptional subtype and clinical outcomes
To determine if tumor tissue transcriptional subtypes can be detected
Secondary outcome measures
To assess the potential for liquid biopsy in SCLC
To test which tissue and sample variables confound gene expression subtypes
Other outcome measures
To identify biomarkers and mechanisms of progression
To measure biomarkers of SCLC using the TEMPUS xT assay
To study progression free survival (PFS) and overall survival (OS)
Side effects data
From 2016 Phase 3 trial • 356 Patients • NCT0004899731%
Fatigue (lethargy, malaise, asthenia)
23%
Alopecia
17%
Late RT Toxicity: Other: NOS
11%
Nausea
10%
Anorexia
9%
Late RT Toxicity: Brain: NOS
9%
Headache
7%
Late RT Toxicity: Skin: NOS
6%
Memory loss
1%
Dyspnea (shortness of breath)
1%
Hemorrhage-Other
1%
Ataxia (incoordination)
1%
Mood alteration-depression
1%
Pain-Other
100%
80%
60%
40%
20%
0%
Study treatment Arm
Prophylactic Cranial Irradiation (PCI)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Patients with Small Cell Lung Cancer (SCLC)Experimental Treatment1 Intervention
This protocol will include participants with newly diagnosed extensive stage (stage IV) small cell lung cancer with tissue collected from the primary lung tumor, or metastatic sites outside of the liver or biliary system.
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Who is running the clinical trial?
Tempus AILead Sponsor
16 Previous Clinical Trials
17,854 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,352 Previous Clinical Trials
288,646,759 Total Patients Enrolled
Tempus LabsLead Sponsor
16 Previous Clinical Trials
18,354 Total Patients Enrolled
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