Comprehensive Oncogenomic Mapping and Exploration in Thoracic and Head & Neck Oncology

Official title

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

Overview

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.

Interventions

• 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 al

Primary outcome measures

• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07550049 · STUDY00162327

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗