Manual Review Required

HER2 / ERBB2 amplification

NSCLC · Small Molecule Inhibitor

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.

Role evidence

Usage summary

Strongest role: Inclusion Required

Inclusion-required count: 2

Treatment-assignment count: 0

Stratification count: 0

Threshold snippets

Fragmentation view

Threshold count: 1

Common snippets: KRAS G12C

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/NCT06185400 | https://clinicaltrials.gov/study/NCT05751018 | https://clinicaltrials.gov/study/NCT03399487 | https://clinicaltrials.gov/study/NCT07012031