Cdx Established Context

HER2 / ERBB2 expression

gastric cancer · Immune Checkpoint Inhibitor

HER2 / ERBB2 expression is flagged as cdx established context because public trials show inclusion required evidence in 14 contexts. FDA CDx context exists. Threshold text varies across public records.

Role evidence

Usage summary

Strongest role: Inclusion Required

Inclusion-required count: 13

Treatment-assignment count: 0

Stratification count: 0

Threshold snippets

Fragmentation view

Threshold count: 10

Common snippets: PD-L1 CPS ≥10 | PD-L1 CPS ≥1 | PD-L1 CPS ≥1

Threshold label: Fragmented

FDA CDx context

Mapping summary

CDx label: Fda Cdx Context Exists

CDx maturity score: 5/5

Confidence: Medium

Patent-density signal

Diagnostic appendix

Signal count: 0

Recent signals: 0

Density label: Low

Source links

Evidence paths

https://clinicaltrials.gov/study/NCT03505320 | https://clinicaltrials.gov/study/NCT03342937 | https://clinicaltrials.gov/study/NCT02494583 | https://clinicaltrials.gov/study/NCT02689284 | https://clinicaltrials.gov/study/NCT03647969 | https://clinicaltrials.gov/study/NCT07432295 | https://clinicaltrials.gov/study/NCT03959293 | https://clinicaltrials.gov/study/NCT05535569 | https://clinicaltrials.gov/study/NCT03407976 | https://clinicaltrials.gov/study/NCT07673887 | https://clinicaltrials.gov/study/NCT07431281 | https://clinicaltrials.gov/study/NCT06901531 | https://clinicaltrials.gov/study/NCT07270991 | https://clinicaltrials.gov/study/NCT05365581