Manual Review Required

PD-L1 expression

solid tumor basket · Small Molecule Inhibitor

PD-L1 expression is flagged as manual review required because public trials show inclusion required evidence in 56 contexts. FDA CDx context should be reviewed manually. Threshold text varies across public records.

Role evidence

Usage summary

Strongest role: Inclusion Required

Inclusion-required count: 23

Treatment-assignment count: 0

Stratification count: 5

Threshold snippets

Fragmentation view

Threshold count: 29

Common snippets: PD-L1 CPS ≥1 | HER2 IHC 3+ | HER2 IHC 3+

Threshold label: Fragmented

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: 1

Recent signals: 1

Density label: Low

Source links

Evidence paths

https://clinicaltrials.gov/study/NCT07071103 | https://clinicaltrials.gov/study/NCT03803774 | https://clinicaltrials.gov/study/NCT07662720 | https://clinicaltrials.gov/study/NCT04601857 | https://clinicaltrials.gov/study/NCT04729725 | https://clinicaltrials.gov/study/NCT07404332 | https://clinicaltrials.gov/study/NCT05507541 | https://clinicaltrials.gov/study/NCT06340568 | https://clinicaltrials.gov/study/NCT07142200 | https://clinicaltrials.gov/study/NCT05821751 | https://clinicaltrials.gov/study/NCT05445648 | https://clinicaltrials.gov/study/NCT02935361 | https://clinicaltrials.gov/study/NCT03082534 | https://clinicaltrials.gov/study/NCT03495323 | https://clinicaltrials.gov/study/NCT04284787 | https://clinicaltrials.gov/study/NCT07238569 | https://clinicaltrials.gov/study/NCT04550624 | https://clinicaltrials.gov/study/NCT03884998 | https://clinicaltrials.gov/study/NCT03971214 | https://clinicaltrials.gov/study/NCT04963153 | https://clinicaltrials.gov/study/NCT04800978 | https://clinicaltrials.gov/study/NCT05659251 | https://clinicaltrials.gov/study/NCT05425602 | https://clinicaltrials.gov/study/NCT07497919 | https://clinicaltrials.gov/study/NCT05354323 | https://clinicaltrials.gov/study/NCT06614140 | https://clinicaltrials.gov/study/NCT04282109 | https://clinicaltrials.gov/study/NCT06439836 | https://clinicaltrials.gov/study/NCT06528210 | https://clinicaltrials.gov/study/NCT04681469 | https://clinicaltrials.gov/study/NCT05505825 | https://clinicaltrials.gov/study/NCT07692932 | https://clinicaltrials.gov/study/NCT06576973 | https://clinicaltrials.gov/study/NCT05440864 | https://clinicaltrials.gov/study/NCT03827044 | https://clinicaltrials.gov/study/NCT04512534 | https://clinicaltrials.gov/study/NCT03601455 | https://clinicaltrials.gov/study/NCT06151743 | https://clinicaltrials.gov/study/NCT04019964 | https://clinicaltrials.gov/study/NCT03544723 | https://clinicaltrials.gov/study/NCT03697304 | https://clinicaltrials.gov/study/NCT03816345 | https://clinicaltrials.gov/study/NCT03694834 | https://clinicaltrials.gov/study/NCT05860335 | https://clinicaltrials.gov/study/NCT07319429 | https://clinicaltrials.gov/study/NCT03607890 | https://clinicaltrials.gov/study/NCT04389151 | https://clinicaltrials.gov/study/NCT07270666 | https://clinicaltrials.gov/study/NCT07243626 | https://clinicaltrials.gov/study/NCT05879822 | https://clinicaltrials.gov/study/NCT05550558 | https://clinicaltrials.gov/study/NCT06914297 | https://clinicaltrials.gov/study/NCT03026140 | https://clinicaltrials.gov/study/NCT06270706 | https://clinicaltrials.gov/study/NCT04150900 | https://clinicaltrials.gov/study/NCT04576091