No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
200 (estimated)
Sponsor
Tempus AI · Industry
Who this trial is looking for
This trial is looking for people with extensive stage small cell lung cancer. Participants will provide tumor and blood samples while they receive standard treatment for their cancer.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with small cell lung cancer.
I have a tumor sample from before I started treatment.
I am planning to receive standard treatment involving etoposide and platinum.
I have a performance status score of 0-2.
I can provide informed consent.
I have extensive stage disease as defined in the guidelines.
I am willing to provide additional blood samples.
You may not be able to join if
I have another cancer diagnosis that was within the last 3 years.
I have a mixed small cell and non-small cell lung cancer.
My small cell cancer started in a different organ.
I have large cell neuroendocrine cancer.
I have carcinoid or atypical carcinoid tumors.
I have had transformed small cell lung cancer due to prior treatment.
I have received an investigational treatment that is not a PD-1 or PD-L1 inhibitor.
I am not willing to provide additional blood samples.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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Status
Eligibility 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 need…
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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