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.

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Key information

Conditions

Small Cell Lung Cancer Adenoma Bronchial Neoplasms Carcinoma, Bronchogenic Head and Neck Cancer Head and Neck Neoplasms Lung Diseases Lung Neoplasms Malignant Pleural Mesothelioma Mesothelioma Mesothelioma, Malignant Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial Pleural Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

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
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.

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

Treatment and study plan

Blood and Tissue Collection

Other

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.

Primary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Margana Whyte

CONTACT

[email protected]

(913) 945-6050

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Official study title

COMETH Study: Comprehensive Oncogenomic Mapping and Exploration in Thoracic and Head & Neck Oncology

Acronym: COMETH

Important dates

Study start: 2026
Primary completion: 2029
Study completion: 2029
First posted: Apr 24, 2026
Registry last updated: Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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