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Repotrectinib

Phase 3

Carcinoma, Non-Small-Cell Lung | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Nov 21, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment190
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06140836A Study of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3)PHASE3 ACTIVE NOT_RECRUITING 190Dec 21, 2023Mar 15, 2027Nov 21, 2025122 United States, Argentina +19
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Study Endpoints
Primary Endpoints
Progression-free Survival (PFS) as per Blinded Independent Central Review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Up to approximately 41 months
Secondary Endpoints
Overall Survival (OS)
Up to approximately 41 months
Overall Response Rate (ORR) as per BICR according to RECIST v1.1
Up to approximately 41 months
ORR as per Investigator according to RECIST v1.1
Up to approximately 41 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm AEXPERIMENTAL -
Arm BACTIVE_COMPARATOR -
Interventions
NameTypeDescription
RepotrectinibDRUGSpecified dose on specified days
CrizotinibDRUGSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites122

Inclusion Criteria: * Participant has histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC * Participant has a ROS1 gene rearrangement/fusion as detected by a local test. * At least 1 measurable lesion according to RECIST v1.1, as assessed by the investigator....

Countries:United StatesArgentinaAustriaBrazilCanadaChileChinaFranceGermanyGreeceHungaryIndiaItalyJapanNetherlandsPolandRomaniaSouth KoreaSpainSwitzerlandTurkey (Türkiye)
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06140836primaryCompletionDate: changed
LOWMay 24, 2026NCT06140836studyFirstPostDate: changed