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).
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/exclusion criteria apply
Primary outcome:
1. Progression-free Survival (PFS) as per Blinded Independent Central Review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (Time Frame - Up to 64 months)
Secondary outcome:
1. Overall Survival (OS) (Time Frame - Up to 87 months)
2. Overall Response Rate (ORR) as per BICR according to RECIST v1.1 (Time Frame - Up to 64 months)
3. ORR as per Investigator according to RECIST v1.1 (Time Frame - Up to 64 months)
4. Duration of Response (DOR) as per BICR according to RECIST v1.1 (Time Frame - Up to 64 months)
5. DOR as per Investigator according to RECIST v1.1 (Time Frame - Up to 64 months)
6. Time to Response (TTR) as per BICR according to RECIST v1.1 (Time Frame - Up to 64 months)
7. TTR as per Investigator according to RECIST v1.1 (Time Frame - Up to 64 months)
8. PFS as per Investigator according to RECIST v1.1 (Time Frame - Up to 64 months)
9. Time to intracranial progressions as per BICR according to RECIST v1.1 (Time Frame - Up to 64 months)
10. Number of participants with Adverse Events (AEs), Serious AEs (SAEs), AEs leading to study intervention discontinuation, and drug-related AEs (Time Frame - Up to 30 days after last dose)
11. Number of deaths (Time Frame - Up to 30 days after last dose)
12. Number of participants without at least a 3-point change in the Non-Small Cell Lung Cancer-Symptom Assessment Questionnaire (NSCLC-SAQ) total score (Time Frame - Up to 30 days after last dose)
- Experimental: Arm A
- Active Comparator: Arm B
- Repotrectinib (BMS-986472):
Specified dose on specified days - Crizotinib (Xalkori):
Specified dose on specified days
Quelle: ClinicalTrials.gov
