Trials Today

Condition

• Small Cell Lung Cancer

Eligibility

Eligible Ages

Over 18 Years

Eligible Sex

All

Accepts Healthy Volunteers

No

Criteria

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:

1. Histologically confirmed small cell lung cancer diagnosis

2. Diagnosis made with excisional or core needle biopsy specimen (fine needle aspirate
may be permitted with approval from the Medical Monitor)

3. 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.

4. ECOG performance status of 0-2 at time of enrollment

5. 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)

6. 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.

7. 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).

8. Willing and able to provide informed consent

9. 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:

1. 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:

1. 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.

2. 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.

2. Mixed small cell and non-small cell histology

3. 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)

4. Large Cell Neuroendocrine cancers

5. Carcinoids or atypical carcinoid tumors

6. Transformed small cell lung cancer emerging in the setting of targeted therapy for
NSCLC

7. Treated with an investigational agent of another immunotherapy class (i.e., non PD-1
or PD-L1 inhibitor)

8. Not willing to have additional blood samples collected

Study Contact