臨床研究等提出・公開システム

Randomized, Open-label, Multicenter, Phase 3 Trial of Repotrectinib Versus Crizotinib in
Participants with Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naive
ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3)

A Study of Repotrectinib Versus Crizotinib in Participants with Locally Advanced or
Metastatic Tyrosine Kinase Inhibitor (TKI)-naive ROS1-positive Non-Small Cell Lung Cancer
(NSCLC) (TRIDENT-3) (CA1271030)

Shi Hong

Bristol-Myers Squibb

1-2-1 Otemachi, Chiyoda-ku, Tokyo

mg-jp-clinical_trial@bms.com

Shi Hong

Bristol-Myers Squibb

1-2-1 Otemachi, Chiyoda-ku, Tokyo

+81-120-093-507

MG-JP-RCO-JRCT@bms.com

Not Recruiting

Dec. 18, 2023

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

- 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.
- Participants must not be exposed previously with TKIs that demonstrated activities in ROS1-positive NSCLC
- Up to 1 prior line of systemic treatment for NSCLC is permitted
- ECOG Performance Status is 2 or less

- Symptomatic brain metastases or symptomatic leptomeningeal involvement.
- History of previous cancer requiring therapy within the previous 2 years, except for NSCLC under study, squamous cell or basal-cell carcinoma of the skin, or any in situ
carcinoma that has been completely resected.
- Known tumor targetable co-mutations or rearrangements
- Clinically significant cardiovascular disease (either active or within 6 months prior to enrollment)

Both

Carcinoma, Non-Small-Cell Lung

Repotrectinib (Arm A): 160 mg once daily (QD) orally for the first 14 days, after which the
dosing frequency will be increased to 160 mg twice daily (BID), if tolerated
Crizotinib (Arm B): 250 mg BID orally

PFS per BICR, according to RECIST v1.1 [Time Frame: Up to 64 months]

OS, ORR, DOR, TTR, PFS, Time to intracranial progression, Incidence of AEs, SAEs, AEs leading to study intervention discontinuation, drug-related AEs, and deaths, and Proportion of participants without meaningful symptom deterioration as measured by the NSCLC-SAQ total scor

+81-22-222-6181

Nov. 16, 2023

No

US/Argentina/Austria/Brazil/Canada/Czech Republic/Chile/China/France/Germany/Greece/Hungary/Italy/India/Poland/Romania/Spain/Korea/Swizerland/Turkey