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
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 design
Treatments tested in this trial
- Observation
Treatment groups
200 Participants
are divided into 1 treatment groupSponsors and collaborators
Tempus AI
Lead sponsor
AstraZeneca
Collaborator
Source ClinicalTrials.gov