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Repotrectinib

Phase 3

Carcinoma, Non-Small-Cell Lung | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: May 27, 2026

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Trial Design
RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment190
FDA Designations
No designations recorded
Clinical trial landscape

Repotrectinib · 6 trials · 7 indications

Phase 3 1Phase 1 5
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)Carcinoma, Non-Small-Cell Lung
ACTIVE NOT_RECRUITING190 Analytics
PHASE3ACTIVE NOT_RECRUITING
A 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)
Carcinoma, Non-Small-Cell Lung
NCT06140836190
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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
Cohort 1: Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration of AUC (0-T) of Probe Substrate With Repotrectinib
Up to approximately Day 17 post dose

Probe substrate contains metformin, digoxin, and rosuvastatin.

Cohort 1: AUC (0-T) of Probe Substrate Without Repotrectinib
Up to approximately Day 17 post dose

Probe substrate contains metformin, digoxin, and rosuvastatin.

Cohort 1: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of Probe Substrate With Repotrectinib
Up to approximately Day 17 post dose

Probe substrate contains metformin, digoxin, and rosuvastatin.

Cohort 1: AUC(INF) of Probe Substrate Without Repotrectinib
Up to approximately Day 17 post dose

Probe substrate contains metformin, digoxin, and rosuvastatin.

Cohort 1: Maximum Observed Plasma Concentration (Cmax) of Probe Substrate With Repotrectinib
Up to approximately Day 17 post dose

Probe substrate contains metformin, digoxin, and rosuvastatin

Cohort 1: Cmax of Probe Substrate Without Repotrectinib
Up to approximately Day 17 post dose

Probe substrate contains metformin, digoxin, and rosuvastatin

Cohort 1: Area Under the Plasma Concentration-time Curve From Time Zero to 48 Hours Post Dose (AUC (0-48)) of Metformin With Repotrectinib
Up to approximately Day 17 post dose
Cohort 1: AUC (0-48) of Metformin Without Repotrectinib
Up to approximately Day 17 post dose
Cohort 1: Renal Clearance (CLR) of Metformin in Urine
Up to approximately Day 16 post dose
Cohort 2: AUC (0-T) of Probe Substrate With Repotrectinib
Up to approximately Day 17 post dose

Probe substrate contains bupropion, hydroxybupropion, flurbiprofen, 4'-hydroxyflurbiprofen, omeprazole, 5'- hydroxyomeprazole)

Cohort 2: AUC (0-T) of Probe Substrate Without Repotrectinib
Up to approximately Day 17 post dose

Probe substrate contains bupropion, hydroxybupropion, flurbiprofen, 4'-hydroxyflurbiprofen, omeprazole, 5'- hydroxyomeprazole)

Cohort 2: AUC (INF) of Probe Substrate With Repotrectinib
Up to approximately Day 17 post dose

Probe substrate contains bupropion, hydroxybupropion, flurbiprofen, 4'-hydroxyflurbiprofen, omeprazole, 5'- hydroxyomeprazole)

Cohort 2: AUC (INF) of Probe Substrate Without Repotrectinib
Up to approximately Day 17 post dose

Probe substrate contains bupropion, hydroxybupropion, flurbiprofen, 4'-hydroxyflurbiprofen, omeprazole, 5'- hydroxyomeprazole)

Cohort 2: Cmax of Probe Substrate With Repotrectinib
Up to approximately Day 17 post dose

Probe substrate contains bupropion, hydroxybupropion, flurbiprofen, 4'-hydroxyflurbiprofen, omeprazole, 5'- hydroxyomeprazole)

Cohort 2: Cmax of Probe Substrate Without Repotrectinib
Up to approximately Day 17 post dose

Probe substrate contains bupropion, hydroxybupropion, flurbiprofen, 4'-hydroxyflurbiprofen, omeprazole, 5'- hydroxyomeprazole)

Maximum observed plasma concentration (Cmax)
Up to Day 23
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Up to Day 23
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Up to Day 23
Time of maximum observed plasma concentration (Tmax)
Days 1 to 11
Dose limiting toxicities (DLTs) (Phase 1)
Within 28 days of the first repotrectinib dose

Define the dose limiting toxicities (DLTs) (Phase 1)

Pediatric Recommended Phase 2 Dose (RP2D) (Phase 1)
Within 28 days of the last patient dosed in escalation

To determine the pediatric RP2D (Phase 1)

Overall Response Rate (ORR) (Phase 2)
Two to three years after first dose of repotrectinib

To determine the confirmed ORR of repotrectinib (TPX-0005) as assessed by Blinded Independent Central Review (Phase 2)

Recommended Phase 2 Dose (RP2D) (Phase 1)
Within 28 days of the last patient dosed in escalation

To determine the RP2D (Phase 1)

Overall Response Rate (ORR) Phase 2
Two to three years after first dose of repotrectinib dose

To determine the confirmed ORR of repotrectinib (TPX-0005) as assessed by Blinded Independent Central Review (Phase 2)

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 -
Cohort 1EXPERIMENTAL -
Cohort 2EXPERIMENTAL -
Part 1EXPERIMENTAL -
Part 2EXPERIMENTAL -
Group 1: Moderate Hepatic ImpairmentEXPERIMENTAL -
Group 2: Severe Hepatic ImpairmentEXPERIMENTAL -
Group 3: Normal Hepatic FunctionEXPERIMENTAL -
Repotrectinib (TPX-0005)EXPERIMENTALPhase 1 Oral repotrectinib (TPX-0005): Safety and tolerability at different dose levels Phase 2 Oral repotrectinib (TPX-0005): 3 cohorts Cohort 1: TKI-naive NTRK fusion Cohort 2: Prior TKI NTRK fusion Cohort 3: ROS1 gene fusions or other ROS1 aberrations
Interventions
NameTypeDescription
RepotrectinibDRUGSpecified dose on specified days
CrizotinibDRUGSpecified dose on specified days
MetforminDRUGSpecified dose on specified days
DigoxinDRUGSpecified dose on specified days
RosuvastatinDRUGSpecified dose on specified days
BupropionDRUGSpecified dose on specified days
FlurbiprofenDRUGSpecified dose on specified days
OmeprazoleDRUGSpecified dose on specified days
VoriconazoleDRUGSpecified dose on specified days
QuinidineDRUGSpecified dose on specified days
Oral repotrectinib (TPX-0005)DRUGOral repotrectinib (TPX-0005)
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Eligibility Criteria
Age Range18 Years to 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)AustraliaDenmarkSingaporeTaiwanUnited KingdomBelgiumHong Kong
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Recent Changes (Last 90 Days)
LOWMay 28, 2026NCT03093116lastUpdatePostDate: changed
LOWMay 28, 2026NCT03093116lastUpdatePostDate: changed
HIGHMay 26, 2026NCT07223671TRIAL_REMOVED: changed
LOWMay 26, 2026NCT04094610primaryCompletionDate: changed
LOWMay 26, 2026NCT03093116primaryCompletionDate: changed
LOWMay 26, 2026NCT06140836primaryCompletionDate: changed
LOWMay 24, 2026NCT04094610studyFirstPostDate: changed
LOWMay 24, 2026NCT03093116studyFirstPostDate: changed
LOWMay 24, 2026NCT07223671studyFirstPostDate: changed
LOWMay 24, 2026NCT06140836studyFirstPostDate: changed