Metastatic Non-small Cell Lung Cancer Advanced Lung Cancer
Conditions
Interventions
Sponsors
Bristol-Myers Squibb Company
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for clinical performance study: Only patients with NSCLC that harbour homozygous MTAP deletion are included in this CPS. Participants will undergo central biomarker testing with F1CDx for enrolment purposes and will only be enrolled if they harbour an MTAP deletion. Alternatively, participants may be included based on available sponsor pre-approved local NGS test or other sponsor provided central test result. Participants enrolled based on an available local NGS result will not provide a tissue sample for prospective confirmatory testing with F1CDx but must still submit material prior to treatment for storage with the study sponsor to be used for clinical bridging. Refer to Section 6.1 of the CA2400029 study protocol for additional inclusion criteria for subjects participating in the CA2400029 study.
Exclusion criteria
Exclusion criteria: Exclusion criteria for clinical performance study: Patients without homozygous MTAP deletion as detected by the enrolment or local assays in the CA2400029 study. Refer to Section 6.2 of the CA2400029 study protocol for exclusion criteria for subjects participating in the CA2400029 study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints from the CA2400029 clinical trial will be used in the CPS to establish the clinical performance of F1CDx as a CDx for BMS-986504 in 1L metastatic NSCLC patients with homozygous MTAP deletion. The primary endpoint of the clinical trial CA2400029 phase 2 is progression-free survival (PFS) by Response Evaluation Criteria in Solid Tumours Guideline (RECIST v1.1) per investigator assessment, defined as the time between the randomization date and the date of disease progression or death from any cause (whichever occurs first). The dual primary endpoints of the clinical trial CA2400029 phase 3 are (1) PFS by RECIST v1.1 per BICR, defined as the time between randomization date and the date of disease progression or death from any cause (whichever occurs first), and (2) overall survival (OS), defined as the time between the randomization date and the date of death due to any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include efficacy endpoints such as objective response (OR), disease control (DC), DOR, investigator-assessed PFS, and investigator-assessed PFS2. | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, China, Colombia, Czech Republic, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Romania, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, United States
Contacts
Public ContactS Bollinger
Bristol-Myers Squibb Company
Outcome results
None listed