Carcinoma, Non-Small-Cell Lung
Conditions
Keywords
TKI-naïve, ROS1, NSCLC, ROS1-positive non-small cell lung cancer
Brief summary
The purpose of this study is to evaluate the efficacy and safety of repotrectinib and crizotinib in participants with locally advanced or metastatic TKI-naïve ROS1-positive non-small cell lung cancer (NSCLC).
Interventions
DRUGRepotrectinib
Specified dose on specified days
DRUGCrizotinib
Specified dose on specified days
Sponsors
Zai Lab (Shanghai) Co., Ltd.
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 ≤ 2
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) Note: Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Duration of Response (DOR) as per BICR according to RECIST v1.1 | Up to approximately 41 months |
| DOR as per Investigator according to RECIST v1.1 | Up to approximately 41 months |
| Time to Response (TTR) as per BICR according to RECIST v1.1 | Up to approximately 41 months |
| Overall Survival (OS) | Up to approximately 41 months |
| PFS as per Investigator according to RECIST v1.1 | Up to approximately 41 months |
| Time to intracranial progressions as per BICR according to RECIST v1.1 | Up to approximately 41 months |
| Number of participants with Adverse Events (AEs), Serious AEs (SAEs), AEs leading to study intervention discontinuation, and drug-related AEs | Up to 30 days after last dose |
| Number of deaths | Up to 30 days after last dose |
| Number of participants without at least a 3-point change in the Non-Small Cell Lung Cancer-Symptom Assessment Questionnaire (NSCLC-SAQ) total score | Up to 30 days after last dose |
| TTR as per Investigator according to RECIST v1.1 | Up to approximately 41 months |
Countries
Argentina, Austria, Brazil, Canada, Chile, China, France, Germany, Greece, Hungary, India, Italy, Japan, Netherlands, Poland, Romania, South Korea, Spain, Switzerland, Turkey (Türkiye), United States
Outcome results
None listed