Biopsy tissue analysis is central for therapeutic decision-making in the era of precision oncology. Insufficient tumor tissue and incomplete genotyping, which prevents access to targeted therapies, are considerable challenges in lung cancer patients. Liquid biopsies, a non-invasive alternative to tissue, offer more accurate capture of tumor heterogeneity and greater flexibility for real-time disease monitoring at significantly reduced cost and risk to patients. Early evidence suggests that liquid biopsies can detect actionable biomarkers in non-small cell lung cancer (NSCLC).
This prospective multi-center observational study will evaluate the clinical utility of returning profiling results in blood and/or tissue using the Oncomine Precision Assay (OPA) in non-small cell lung cancer (NSCLC) patients. Eligible patients have stage IIIb/IV, non-squamous NSCLC (mixed squamous and adenocarcinoma is allowed) and have received no prior systemic therapy for advanced stage. The primary objective of the study is to determine the non-inferiority of the OPA verses standard of care (SOC) based on the proportion of patients for whom a genomic aberration is detected in at least one of the eight recommended genes (ROS1, ERBB2, MET, BRAF, KRAS, RET, ALK, and EGFR). Secondary objective is to assess the clinical utility of returning genomic aberration detected with the OPA by tallying the number of patients who received targeted therapy or enrolled into a trial based on the OPA results and turnaround time. A baseline plasma sample will be collected for up to 200 patients, of which up to 100 patients will have an archived tumor tissue collected. At progression, for patients who received targeted/immune therapy, another blood sample will be collected and profiled to monitor emergence of resistance. This study was initiated in May 2021 and enrolment is ongoing at 6 Canadian sites.
NCT04564079.
Exactis Innovation.
Thermo Fisher Scientific.
N. Leighl: Financial Interests, Personal, Other, CME/independent lectures: MSD, BMS, Hoffmann-La Roche, EMD Serono; Financial Interests, Personal, Invited Speaker, independent lectures: Novartis, Takeda; Financial Interests, Personal, Advisory Board: Puma Biotechnology; Financial Interests, Institutional, Research Grant: Amgen, AstraZeneca, Array, Bayer, EMD Serono, Guardant Health, Lilly, MSD, Pfizer, Roche, Takeda. All other authors have declared no conflicts of interest.