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)
Active, not recruiting
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Registration Number
- jRCT2021230046
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 190
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.
- 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
Exclusion 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)
Study & Design
- Study Type
- Interventional
- Study Design
- parallel assignment
- Primary Outcome Measures
Name Time Method - PFS per BICR, according to RECIST v1.1 [Time Frame: Up to 64 months]
- Secondary Outcome Measures
Name Time Method