Comprehensive Oncogenomic Mapping and Exploration in Thoracic and Head & Neck Oncology (COMETH)

April 17, 2026 updated by: Chao Huang, University of Kansas Medical Center

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants will be recruited from the patient population of The University of Kansas and affiliated sites.

Description

Inclusion Criteria:

  • 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:

    1. Advanced stage (IIIB to IV) non-small cell lung cancer (all types including mixed histology, without actionable mutations)
    2. Extensive-stage small cell lung cancer that are treatment naïve that will receive immunotherapy and chemotherapy
    3. Recurrent or metastaƟc squamous cell head and neck cancers, squamous cell, HPV posiƟve or HPV negaƟve, treatment naïve that will start immunotherapy and chemotherapy
    4. 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Stage IIIB, IIIC or IV Non-small cell lung cancer
Participants with non-small cell lung cancer.
Other: Blood and Tissue Collection

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.
Extensive-stage Small-cell lung cancer
Participants with extensive stage small-cell lung cancer.
Other: Blood and Tissue Collection

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.
Metastatic squamous cell Head and Neck cancer
Participants with metastatic squamous-cell head and neck cancer.
Other: Blood and Tissue Collection

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.
Malignant Pleural Mesothelioma
Participants with advanced malignant pleural mesothelioma.
Other: Blood and Tissue Collection

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Investigators

  • Principal Investigator: Chao Huang, MD, The University of Kansas Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

April 1, 2029

Study Registration Dates

First Submitted

April 17, 2026

First Submitted That Met QC Criteria

April 17, 2026

First Posted (Actual)

April 24, 2026

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00162327

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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