Asset profile

BPI-361175

Small molecule

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Weakdesign only

Evidence outlook · results not reported

NCT05329298 · Non-small Cell Lung Cancer

The lead study uses a design that frequently fails to replicate under controlled conditions, and its results have not been reported. This tier describes the design, not an outcome.

NCT05329298: This is an open-label, non-randomized phase 1/2 dose-escalation and expansion study in which every participant received BPI-361175 with no placebo or active comparator, and no blinding was used. Results have not been posted, and because the design never included a controlled comparison, it cannot demonstrate a controlled treatment effect regardless.

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Competitive landscape

102 competitors in this universe: 41 direct rivals (same mechanism and indication), 1 same-class, 60 same-indication; 84 further along in development.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
BPI-361175: this drugPhase 1/2Small moleculeEGFR
GefitinibApprovedSmall moleculeEGFR
LazertinibApprovedSmall moleculeEGFR
Osimertinib (Tagrisso)ApprovedSmall moleculeEGFR
SunvozertinibApprovedSmall moleculeEGFR
AlflutinibPhase 3Small moleculeEGFR
AlmonertinibPhase 3Small moleculeEGFR
BefotertinibPhase 3Small moleculeEGFR
BPI-7711Phase 3Small moleculeEGFR
CPO301Phase 3Antibody–drug conjugateEGFR
FHND9041Phase 3Small moleculeEGFR
IcotinibPhase 3Small moleculeEGFR
JMT101Phase 3Monoclonal antibodyEGFR
LimertinibPhase 3Small moleculeEGFR, EGFR T790M (resistant mutant, selective over wild-type EGFR)
PLB1004Phase 3Small moleculeEGFR
SH-1028Phase 3Small moleculeEGFR

…and 87 more. Research shows the complete landscape.

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Upcoming events

(1 total)

Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.

2028 (1)
January 2028 (1)
Phase 1/2Non-small Cell Lung CarcinomaNot yet recruiting
Est. primary completion 2028-01-30 · NCT05393466 · CT.gov ↗
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All registered studies

Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.