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PFS is defined as the time from Brigatinib initiation until tumor progression or death from any cause according to RECIST v1.1, evaluated by the expert panel. Radiological evaluation of the target lesions(s) will be performed at the following time points: Screening, then every 8 weeks during the first year then every 12 weeks thereafter. An expert panel of blinded clinicians will anonymously review the radiological evaluations and confirm/infirm the Investigator's assessment. Each Investigator must provide all the documents necessary to assess the various endpoints. Progression occurring before 2 years will be considered for the endpoint. Patients alive without progression will be censored at the last radiological assessment.
PFS is defined as the time from Brigatinib initiation until tumor progression or death from any cause according to RECIST v1.1, evaluated by the investigators. Radiological evaluation of the target lesions(s) will be performed at the following time points: Screening, then every 8 weeks during the first year then every 12 weeks thereafter. If a Computed Tomography (CT) scan for tumor assessment is performed in a Positron Emission Tomography (PET) scanner or CT scanner, the CT acquisition must be consistent with the standards for a full-contrast diagnostic CT scan. Response will be assessed by the Investigator at each center using RECIST v1.1. Assessments should be performed by the same evaluator, if possible, to ensure internal consistency across visits. Progression occurring before 2 years will be considered for the endpoint. Patients alive without progression will be censored at the last radiological assessment.
Overall survival defined as the time from Brigatinib initiation until death or lost of follow up. Patients alive will be censored at the date of last news or data cutoff. The patient's status (dead, alive or censored) will be determined at the same time points as PFS (Screening, then every 8 weeks during the first year then every 12 weeks thereafter) in order to evaluate OS. In addition, OS will be determined during the Post-study Follow-up Period via in-person or phone contact every 3 months.
Median PFS defined as the time from Brigatinib initiation until death or lost of follow up. Patients alive without progressive disease will be censored at the date of last news or data cutoff.
Safety and tolerability : proportion of patients with any adverse event (AE), serious AEs (SAEs) and all AEs of grade ≥3 according to the National Cancer Institute (NCI) Common terminology criteria for adverse events (CTCAE) v5.0 criteria. Participants will be monitored for AEs from the time the informed consent form is signed until 90 days after the last administration of radiotherapy or until 60 days after the last surgery / thermal ablation. Safety assessments may include monitoring of any or all of the following parameters: clinical symptoms, laboratory, pathological, radiological or surgical findings, results of physical examination, or results of other tests and/or procedures. Any later SAE, i.e. occurring after the end of the reporting period, which is considered to be related to the trial intervention(s) or to the research (protocol required diagnostic procedures and examinations carried out during the research) must be reported without any limitation in terms of deadline.
Duration of treatment, defined as the time from the first Brigatinib treatment administration until the date of last treatment administration. Dates of first and last treatment administration will be recorded for each treatment to calculate the duration of treatment.