Drug Development Ahead Of Cdx Context

ALK fusion

solid tumor basket · Monoclonal Antibody

ALK fusion is flagged as drug development ahead of cdx context because public trials show inclusion required evidence in 20 contexts. FDA CDx context should be reviewed manually.

Role evidence

Usage summary

Strongest role: Inclusion Required

Inclusion-required count: 10

Treatment-assignment count: 1

Stratification count: 0

Threshold snippets

Fragmentation view

Threshold count: 8

Common snippets: HER2-low | HER2-low | MSI-H

Threshold label: Moderate

FDA CDx context

Mapping summary

CDx label: Fda Cdx Context Manual Review Required

CDx maturity score: 2/5

Confidence: Medium

Patent-density signal

Diagnostic appendix

Signal count: 0

Recent signals: 0

Density label: Low

Source links

Evidence paths

https://clinicaltrials.gov/study/NCT00816400 | https://clinicaltrials.gov/study/NCT02420821 | https://clinicaltrials.gov/study/NCT02480010 | https://clinicaltrials.gov/study/NCT05942378 | https://clinicaltrials.gov/study/NCT01911273 | https://clinicaltrials.gov/study/NCT04859569 | https://clinicaltrials.gov/study/NCT04878029 | https://clinicaltrials.gov/study/NCT05417594 | https://clinicaltrials.gov/study/NCT03141684 | https://clinicaltrials.gov/study/NCT04589845 | https://clinicaltrials.gov/study/NCT06172296 | https://clinicaltrials.gov/study/NCT01979536 | https://clinicaltrials.gov/study/NCT01620970 | https://clinicaltrials.gov/study/NCT04165317 | https://clinicaltrials.gov/study/NCT03984357 | https://clinicaltrials.gov/study/NCT03014804 | https://clinicaltrials.gov/study/NCT03810339 | https://clinicaltrials.gov/study/NCT02715284 | https://clinicaltrials.gov/study/NCT04551521 | https://clinicaltrials.gov/study/NCT03389802