Lung cancer study aims to unlock genetic secrets
NCT ID NCT05257551
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is observing 200 people with extensive stage small cell lung cancer to learn more about the genetic makeup of their tumors. Researchers will analyze tumor tissue and blood samples to see if certain genetic patterns are linked to how well treatments work. The goal is to better understand the disease, not to test a new treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this study could help doctors better predict how small cell lung cancer will respond to treatment, leading to more personalized care.
- What could go wrong
- This is an observational study, not a treatment trial, so it won't directly improve patient outcomes. Results may not change clinical practice for years.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2022
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
This protocol targets patients with Extensive Stage (ES) Small Cell Lung Cancer (SCLC) receiving first-line and second-line standard of care therapy
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
7 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cancer Care Association of York
RECRUITINGYork, Pennsylvania, 17403, United States
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Cancer and Blood Specialty Clinic
WITHDRAWNLos Alamitos, California, 90720, United States
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Englewood Health Medical Center
WITHDRAWNEnglewood, New Jersey, 07631, United States
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Illinois Cancer Care
RECRUITINGPeoria, Illinois, 61615, United States
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Johns Hopkins University
RECRUITINGBaltimore, Maryland, 21287, United States
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Ohio State University
RECRUITINGColumbus, Ohio, 43210, United States
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OhioHealth Research Institute
WITHDRAWNColumbus, Ohio, 43214, United States
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Oklahoma Cancer Specialists and Research Institutes
WITHDRAWNTulsa, Oklahoma, 74146, United States
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TriHealth Cancer Institute
RECRUITINGCincinnati, Ohio, 45220, United States
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University of Colorado
RECRUITINGAurora, Colorado, 80045, United States
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University of North Carolina
RECRUITINGChapel Hill, North Carolina, 27599, United States
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