Patients with advanced non-squamous non-small cell lung cancer in whom driver oncogenes were not detected using testing at the diagnosis
Conditions
Interventions
None listed
Sponsors
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of newly detected driver oncogenes using Guardant360 CDx. Driver oncogenes are defined as EGFR mutations, ALK fusions, ROS1 fusions, BRAF V600E, MET exon 14 skipping mutations, RET fusions, KRAS G12C mutations, HER2 mutations, and NTRK fusions. These driver gene aberrations are classified as evidence level 1 by OncoKB. | — |
Countries
Japan
Contacts
Public ContactMasaki Ishida
Graduate School of Medical Science, Kyoto Prefectural University of Medicine Department of Pulmonary Medicine
Outcome results
None listed