Phase
Condition
Small Cell Lung Cancer
Neoplasms
Treatment
Observation
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
The following are the inclusion criteria. Participants are eligible to be included in this study only if all the following criteria apply. The participant has/is:
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)
Large Cell Neuroendocrine cancers
Carcinoids or atypical carcinoid tumors
Transformed small cell lung cancer emerging in the setting of targeted therapy for NSCLC
Treated with an investigational agent of another immunotherapy class (i.e., non PD-1 or PD-L1 inhibitor)
Not willing to have additional blood samples collected
Study Design
Connect with a study center
Cancer and Blood Specialty Clinic
Los Alamitos, California 90720
United StatesSite Not Available
University of Colorado
Aurora, Colorado 80045
United StatesActive - Recruiting
Illinois Cancer Care
Peoria, Illinois 61615
United StatesActive - Recruiting
Johns Hopkins University
Baltimore, Maryland 21287
United StatesActive - Recruiting
Englewood Health Medical Center
Englewood, New Jersey 07631
United StatesSite Not Available
University of North Carolina
Chapel Hill, North Carolina 27599
United StatesActive - Recruiting
TriHealth Cancer Institute
Cincinnati, Ohio 45220
United StatesActive - Recruiting
Ohio State University
Columbus, Ohio 43210
United StatesActive - Recruiting
OhioHealth Research Institute
Columbus, Ohio 43214
United StatesSite Not Available
OhioHealth Research Institute
Columbus 4509177, Ohio 5165418 43214
United StatesSite Not Available
Oklahoma Cancer Specialists and Research Institutes
Tulsa, Oklahoma 74146
United StatesSite Not Available
Cancer Care Association of York
York, Pennsylvania 17403
United StatesActive - Recruiting

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