Overview
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.
Eligibility
Inclusion Criteria:
- 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 PI)
- Subjects must submit fresh or archived FFPE tumor sample to the central laboratory
- ECOG performance status of 0 or 1 at time of enrollment
- Planned extensive stage first-line therapy of etoposide plus carboplatin plus PD-L1 inhibitor (atezolizumab or durvalumab)
- Extensive stage disease at time of diagnosis
- Willing and able to provide informed consent
Exclusion Criteria:
- History of prior systemic treatment of SCLC
- History of radiotherapy or planned radiotherapy to all measurable disease foci
- Prior diagnosis of non-small cell lung cancer
- Mixed small cell and non-small cell histology
- Suspected metastatic cancer from other sites (i.e., those without a known or suspected lung primary diagnosis)
- Not willing to have additional blood samples collected