Tokyo, Aug. 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058881) titled 'Guardant360 CDx Observational Study for Hidden Oncogenes in advanced non-squamous NSCLC patients without detected driver mutations at diagnosis' on Aug. 25.

Study Type: Observational

Primary Sponsor: Institute - Graduate School of Medical Science, Kyoto Prefectural University of Medicine

Condition: Condition - Patients with advanced non-squamous non-small cell lung cancer in whom driver oncogenes were not detected using testing at the diagnosis Classification by malignancy - Malignancy Genomic information - YES

Objective: Narrative objectives1 - The primary objective of this study is to clarify the proportion of newly detected driver oncogenes using the Guardant360 CDx under health insurance coverage in patients with advanced non-squamous non-small cell lung cancer who did not driver oncogenes detected using testing at the diagnosis and who have received drug therapy up to the second line. Basic objectives2 - Others

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1) Patients have been diagnosed with non-squamous non-small cell lung cancer by histopathological or cytological examination. 2) No driver gene abnormalities are detected by genetic diagnostic methods at the time of diagnosis. Driver gene abnormalities are defined as EGFR gene mutations, ALK fusion genes, ROS1 fusion genes, BRAF V600E, MET exon 14 skipping mutations, RET fusion genes, KRAS G12C mutations, HER2 gene mutations, and NTRK fusions. Patients will be ineligible if the genetic testing used at the time of diagnosis determines that the submitted specimen is unanalyzable or of poor quality (e.g., insufficient specimen volume, nucleic acid degradation, contamination, etc.). 3) Patients have received up to two standard drug therapies. Patients may or may not have received a prior immune checkpoint inhibitor. Postoperative adjuvant therapy does not count as prior treatment. 4) Patients are scheduled for evaluation using Guardant360 CDx. 5) Patients aged 20 years or older. 6) The contents of the study have been fully explained to the patient prior to enrollment in this clinical study, and written consent has been obtained from the patient. Key exclusion criteria - 1) Patients who have already undergone a cancer gene panel test other than Guardant360 CDx. 2) Patients who were unable to provide written consent. Target Size - 44

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 08 Month 25 Day Anticipated trial start date - 2025 Year 10 Month 01 Day Last follow-up date - 2028 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067253

Disclaimer: Curated by HT Syndication.