Role evidence
Usage summary
Strongest role: Inclusion Required
Inclusion-required count: 1
Treatment-assignment count: 0
Stratification count: 0
Manual Review Required
HER2 / ERBB2 amplification
NSCLC · Therapy Not Normalized
HER2 / ERBB2 amplification is flagged as manual review required because public trials show inclusion required evidence in 4 contexts. FDA CDx context should be reviewed manually.
Threshold snippets
Fragmentation view
Threshold count: 0
Common snippets: None extracted
Threshold label: Low
FDA CDx context
Mapping summary
CDx label: Fda Cdx Context Manual Review Required
CDx maturity score: 2/5
Confidence: Low
Patent-density signal
Diagnostic appendix
Signal count: 0
Recent signals: 0
Density label: Low
Source links
Evidence paths
https://clinicaltrials.gov/study/NCT02965885 | https://clinicaltrials.gov/study/NCT03066206 | https://clinicaltrials.gov/study/NCT01730118 | https://clinicaltrials.gov/study/NCT00073008