Small Cell Lung CancerCOMETHNCT07550049
Comprehensive Oncogenomic Mapping and Exploration in Thoracic and Head & Neck Oncology
An observational study of Small Cell Lung Cancer and Head and Neck Cancer, run by University of Kansas Medical Center.
Trial summary
This is an ancillary laboratory study to collect and bank blood and tissue samples. The biospecimens collected for this study will be invaluable for future research into predictive biomarkers and genomic alterations and their correlation with clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer, Head and Neck Cancer, Malignant Pleural Mesothelioma
- What is being tested?
- Blood and Tissue Collection
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Apr 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited from the patient population of The University of Kansas and affiliated sites.
Who may be able to join
- Ability of participant to understand this study, and participant willingness to sign a written informed consent. NOTE: Remote consenting allowed per IRB policy.
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Males and/or females age ≥ 18 years
- Diagnosis of one of the following:
- Advanced stage (IIIB to IV) non-small cell lung cancer (all types including mixed histology, without actionable mutations)
- Extensive-stage small cell lung cancer that are treatment naïve that will receive immunotherapy and chemotherapy
Show all 11Show fewer
- Recurrent or metastaƟc squamous cell head and neck cancers, squamous cell, HPV posiƟve or HPV negaƟve, treatment naïve that will start immunotherapy and chemotherapy
- Malignant pleural mesothelioma that will be treated with immunotherapy and chemotherapy
- Eligible to receive chemotherapy (plaƟnum based) with an immune checkpoint inhibitor (single or double agents).
- Able to provide consent to obtain a blood sample, prior future genomic research of their samples.
- Planning to start therapy in the next 28 days.
Who cannot join
- Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements
- Presence of a condition(s) or diagnosis, either physical or psychological, or physical exam finding that precludes participation.
- Advanced stage (IIIB to IV) non-small cell lung cancer with actionable mutations
- Active viral infection (Hep C or B) requiring anti-viral therapy in the last 28 days. HIV patients on stable on anti-viral therapy able to receive therapy for the cancer are eligible to participate.
- Active use of prednisone equivalent to more than 10mg/day
- Second malignancy that requires systemic treatment at the time of consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: COMETH Study: Comprehensive Oncogenomic Mapping and Exploration in Thoracic and Head & Neck Oncology
This is an ancillary laboratory study to collect and bank blood and tissue samples. The biospecimens collected for this study will be invaluable for future research into predictive biomarkers and genomic alterations and their correlation with clinical outcomes.
Read the detailed description
The goal of this study is to advance the research into the mechanism of resistance and genomic evaulation during therapy, serial blood samples will be collected from patients with advanced-stage non-small cell lung cancer, extensive-stage small cell lung cancer, metastatic squamous cell carcinoma of the head and neck, and malignant pleural mesothelioma who are inititating immunotherapy, with or without chemotherapy.
- Being tested
- Blood and Tissue Collection
- Keywords
- Biobank, Blood bank, Tissue bank
- Medical subject headings
- Small Cell Lung Carcinoma, Head and Neck Neoplasms, Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and Tissue CollectionOther
Samples will be collected at baseline (prior to treatment), over four cycles of therapy, at six months, and at disease progression. When available, formalin-fixed paraffin-embedded (FFPE) tissue samples will also be obtained.
Tissue samples of the biopsy or additional biopsy done as part of standard of care during the course of treatment will also be collected if available. Specimen number of the biopsy or additional biopsy done as part of standard of care during the course of treatment will also be collected. Specimen number for tissue will be collected to reference for future tissue collection.
| Study group | Role | What they receive |
|---|---|---|
| Stage IIIB, IIIC or IV Non-small cell lung cancer | Participants with non-small cell lung cancer. Receives: Other: Blood and Tissue Collection | |
| Extensive-stage Small-cell lung cancer | Participants with extensive stage small-cell lung cancer. Receives: Other: Blood and Tissue Collection | |
| Metastatic squamous cell Head and Neck cancer | Participants with metastatic squamous-cell head and neck cancer. Receives: Other: Blood and Tissue Collection | |
| Malignant Pleural Mesothelioma | Participants with advanced malignant pleural mesothelioma. Receives: Other: Blood and Tissue Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish a comprehensive blood and tissue biobank
To establish a comprehensive blood and tissue biobank from patients with advanced-stage non-small cell and extensive-stage small cell lung, metastatic squamous cell head and neck cancer and malignant pleural mesothelioma who are initiating first-line chemo-immunotherapy, with the goal of supporting future genomic research.
Measured: Samples will be collected at baseline (prior to treatment), over four cycles of therapy, at six months, and at disease progression; total participant duration minimum of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chao Huang, University of Kansas Medical Center
- Investigators
- Chao Huang, MD, Principal investigator, The University of Kansas Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07550049
- Sponsor's protocol ID
- STUDY00162327
- Acronym
- COMETH
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMETH Study: Comprehensive Oncogenomic Mapping and Exploration in Thoracic and Head & Neck Oncology
- ClinicalTrials.gov ID
- NCT07550049
- Acronym / sponsor ID
- COMETH / STUDY00162327
- Keywords
- Biobank, Blood bank, Tissue bank
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 24 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an ancillary laboratory study to collect and bank blood and tissue samples. The biospecimens collected for this study will be invaluable for future research into predictive biomarkers and genomic alterations and their correlation with clinical outcomes.
Detailed description
The goal of this study is to advance the research into the mechanism of resistance and genomic evaulation during therapy, serial blood samples will be collected from patients with advanced-stage non-small cell lung cancer, extensive-stage small cell lung cancer, metastatic squamous cell carcinoma of the head and neck, and malignant pleural mesothelioma who are inititating immunotherapy, with or without chemotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Stage IIIB, IIIC or IV Non-small cell lung cancer | – | Other: Blood and Tissue CollectionParticipants with non-small cell lung cancer. |
| Extensive-stage Small-cell lung cancer | – | Other: Blood and Tissue CollectionParticipants with extensive stage small-cell lung cancer. |
| Metastatic squamous cell Head and Neck cancer | – | Other: Blood and Tissue CollectionParticipants with metastatic squamous-cell head and neck cancer. |
| Malignant Pleural Mesothelioma | – | Other: Blood and Tissue CollectionParticipants with advanced malignant pleural mesothelioma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from the patient population of The University of Kansas and affiliated sites.
Key inclusion criteria (11 listed)
- Ability of participant to understand this study, and participant willingness to sign a written informed consent. NOTE: Remote consenting allowed per IRB policy.
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Males and/or females age ≥ 18 years
- Diagnosis of one of the following:
- Eligible to receive chemotherapy (plaƟnum based) with an immune checkpoint inhibitor (single or double agents).
Key exclusion criteria (6 listed)
- Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements
- Presence of a condition(s) or diagnosis, either physical or psychological, or physical exam finding that precludes participation.
- Advanced stage (IIIB to IV) non-small cell lung cancer with actionable mutations
- Active viral infection (Hep C or B) requiring anti-viral therapy in the last 28 days. HIV patients on stable on anti-viral therapy able to receive therapy for the cancer are eligible to participate.
- Active use of prednisone equivalent to more than 10mg/day
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood and Tissue CollectionSamples will be collected at baseline (prior to treatment), over four cycles of therapy, at six months, and at disease progression. When available, formalin-fixed paraffin-embedded (FFPE) tissue samples will also be obtained. Tissue samples of the biopsy or additional biopsy done as part of standard of care during the course of treatment will also be collected if available. Specimen number of the biopsy or additional biopsy done as part of standard of care during the course of treatment will also be collected. Specimen number for tissue will be collected to reference for future tissue collection. | Other | Extensive-stage Small-cell lung cancer, Malignant Pleural Mesothelioma, Metastatic squamous cell Head and Neck cancer, Stage IIIB, IIIC or IV Non-small cell lung cancer |
Primary outcome
Establish a comprehensive blood and tissue biobank
Time frame: Samples will be collected at baseline (prior to treatment), over four cycles of therapy, at six months, and at disease progression; total participant duration minimum of 1 year
To establish a comprehensive blood and tissue biobank from patients with advanced-stage non-small cell and extensive-stage small cell lung, metastatic squamous cell head and neck cancer and malignant pleural mesothelioma who are initiating first-line chemo-immunotherapy, with the goal of supporting future genomic research.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chao Huang, MD principal investigator
The University of Kansas Cancer Center
Questions about this trial
What is this clinical trial studying?
An observational study of Small Cell Lung Cancer and Head and Neck Cancer, run by University of Kansas Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Margana Whyte ((913) 945-6050, mwhyte@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish a comprehensive blood and tissue biobank (time frame: Samples will be collected at baseline (prior to treatment), over four cycles of therapy, at six months, and at disease progression; total participant duration minimum of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.