Observational Lung Trial to Collect Tissue to Train and Validate a Live Tumor Diagnostic Platform
Trial Parameters
Brief Summary
The primary objective of this study is to determine the ex-vivo prognostic accuracy of the Cybrid live tumor diagnostic platform using in-vivo RECIST 1.1 as the reference method.
Eligibility Criteria
Subject Inclusion Criteria 1. Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately. 2. Age ≥ 18 years at the time of consent. 3. Subjects suspected of or diagnosed with Stage IV/metastatic NSCLC and meet one of the following criteria: 1. Subjects who are undiagnosed, have undergone imaging and are suspected to have Stage IV lung cancer. 2. Subjects with a previous Stage I, II, or III diagnosis of NSCLC, who are being re-biopsied due to suspected progression to metastatic disease. 3. Subjects who have a newly confirmed diagnosis of Stage IV NSCLC, have undergone a SOC biopsy procedure and will undergo a separate procedure for the purposes of this study prior to starting first line treatment. 4. Subjects who have a previous Stage IV/metastatic NSCLC diagnosis and have already received first line treatment. 4. Subjects must be clinically ab