Lung Cancer Clinical Trial
Observational Trial to Predict Response to Immune Checkpoint Inhibitors in Non-Small Cell Lung Cancer
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.
Cancer is a leading cause of death and despite many new drugs, a major diagnostic challenge remains knowing which drug will work best for a patient. A new class of drugs called checkpoint inhibitors (CPIs) have revolutionized cancer treatment. However, current diagnostic methods (e.g. PDL1, MSI and TMB) do not accurately predict which patients will respond.
Elephas is developing a diagnostic platform using small 3D Live Tumor Fragments (LTFs) from participants for accurate prediction of drug response with a focus on CPIs such as Pembrolizumab (Keytruda). These LTFs contain both tumor cells and infiltrating immune cells, which are critical in determining response to CPIs and other immunotherapies.
In this observational clinical trial, 200 Non-Small Cell Lung Cancer (NSCLC) participants will be recruited and their actual clinical response to CPIs (using RECIST 1.1) will be compared to the platform's predictive Artificial Intelligence (AI) score that is based on RNA, clinical data, and 3D microscopy images. The sensitivity and specificity of the platform's score will be determined and compared to current diagnostic methods for CPIs like PDL1, MSI, and TMB.
Written informed consent and HIPAA authorization for release of personal health information prior to registration.
Age ≥ 18 years at the time of consent.
ECOG ≤ 3.
Suspected of or diagnosed with non-small cell lung cancer (NSCLC).
Must be clinically able, at investigator discretion, to undergo additional core needle biopsy passes (up to four) during their biopsy from a tumor site that yields a biopsy of at least 10 mm in length, and ideally longer. These additional core needle biopsies can be through the primary tumor site (lung) or a metastatic site amenable to additional passes (e.g. liver or lymph nodes).
Must be eligible based on investigator discretion to receive CPI monotherapy or combination therapy (e.g., combining two CPIs such as anti-PD-1 plus anti-CTLA-4) or CPI therapy in combination with chemotherapy or genome-targeted therapy; Must be treatment-naïve at the time of biopsy if newly diagnosed; If patient had Stage I, II, or III cancer and has now progressed to metastatic they cannot have received any anti-cancer treatment for at least 2 months prior to biopsy.
Must plan to receive standard of care systemic anti-cancer treatment after the biopsy.
Must have measurable disease according to RECIST 1.1.
Participants with a secondary cancer diagnosis are eligible to participate, if participation does not interfere with systemic anti-cancer standard of care treatment for Non-Small Cell Lung Cancer.
Any Lung cancer patient for whom an extra biopsy might pose a clinical risk, either due to not having liver, lymph node metastases or for any other reason.
Any (mental) impairment that would render the participant unable to understand his/her participation in the study.
Auto-immune disease that would render them ineligible for immune-oncology treatment.
Immunocompromised state due to disease (e.g., HIV) or medication (e.g., transplant).
Participants enrolled in another interventional clinical trial are not eligible. Participants involved in other observational trials not interrupting standard of care can participate in this study. Participants that enroll in another interventional clinical trial at any point for the duration of the study will no longer be eligible and, therefore, discontinued.
Participants who are pregnant are not eligible.
Participants with relapsing Stage IV lung cancer who are undergoing or plan to undergo a second line of treatment are not eligible.
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