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)

JRCT ID: jRCT2021230046

Registered date:18/12/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Carcinoma, Non-Small-Cell Lung
• Date of first enrollment: 18/12/2023
• Target sample size: 230
• Countries of recruitment: US,Japan,Argentina,Japan,Austria,Japan,Brazil,Japan,Canada,Japan,Czech Republic,Japan,Chile,Japan,China,Japan,France,Japan,Germany,Japan,Greece,Japan,Hungary,Japan,Italy,Japan,India,Japan,Poland,Japan,Romania,Japan,Spain,Japan,Korea,Japan,Swizerland,Japan,Turkey,Japan
• Study type: Interventional

Intervention(s)

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

Outcome(s)

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.
- 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

Exclude criteria

- 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)

Related Information

• Primary Sponsor: Shi Hong
• Secondary ID(s): NCT06140836