Manual Review Required

HER2 / ERBB2 expression

NSCLC · Therapy Not Normalized

HER2 / ERBB2 expression is flagged as manual review required because public trials show inclusion required evidence in 21 contexts. FDA CDx context should be reviewed manually.

Role evidence

Usage summary

Strongest role: Inclusion Required

Inclusion-required count: 15

Treatment-assignment count: 0

Stratification count: 0

Threshold snippets

Fragmentation view

Threshold count: 4

Common snippets: EGFR exon 19 deletion | KRAS G12C | BRAF V600E

Threshold label: Moderate

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/NCT00063154 | https://clinicaltrials.gov/study/NCT07291037 | https://clinicaltrials.gov/study/NCT05653752 | https://clinicaltrials.gov/study/NCT02965885 | https://clinicaltrials.gov/study/NCT05364073 | https://clinicaltrials.gov/study/NCT06329895 | https://clinicaltrials.gov/study/NCT04576208 | https://clinicaltrials.gov/study/NCT06253871 | https://clinicaltrials.gov/study/NCT03808662 | https://clinicaltrials.gov/study/NCT06563999 | https://clinicaltrials.gov/study/NCT06706076 | https://clinicaltrials.gov/study/NCT00548093 | https://clinicaltrials.gov/study/NCT03066206 | https://clinicaltrials.gov/study/NCT06221475 | https://clinicaltrials.gov/study/NCT04129502 | https://clinicaltrials.gov/study/NCT02183883 | https://clinicaltrials.gov/study/NCT06081907 | https://clinicaltrials.gov/study/NCT01730118 | https://clinicaltrials.gov/study/NCT05546268 | https://clinicaltrials.gov/study/NCT04818333 | https://clinicaltrials.gov/study/NCT00073008