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Randomized, Open-label, Multicenter, Phase 3 Trial 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)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505604-32-00
Acronym
CA127-1030
Enrollment
83
Registered
2024-01-10
Start date
2024-01-24
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non small cell lung cancer (NSCLC)

Brief summary

PFS per BICR, according to RECIST v1.1

Detailed description

Overall Survival, Objective Response Rate (ORR), Duration of Response (DOR), Time to Response (TTR) per BICR and per investigator according to RECIST v1.1, PFS per investigator according to RECIST v1.1, Time to intracranial progression per BICR according to RECIST v1.1, Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), AEs leading to study intervention discontinuation, Drug-related AEs and deaths, Proportion of participants without meaningful symptom deterioration as measured by the NSCLC-SAQ total score

Interventions

Sponsors

Bristol-Myers Squibb Services Unlimited Company
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
PFS per BICR, according to RECIST v1.1

Secondary

MeasureTime frame
Overall Survival, Objective Response Rate (ORR), Duration of Response (DOR), Time to Response (TTR) per BICR and per investigator according to RECIST v1.1, PFS per investigator according to RECIST v1.1, Time to intracranial progression per BICR according to RECIST v1.1, Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), AEs leading to study intervention discontinuation, Drug-related AEs and deaths, Proportion of participants without meaningful symptom deterioration as measured by the NSCLC-SAQ total score

Countries

Austria, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026