A Multinational, Non-Interventional, Prospective Study of Nivolumab (BMS-936558) in Patients With Locally Advanced or Metastatic (Stage IIIB-IV) Non-Small Cell Lung Cancer (NSCLC) With Squamous and Non-Squamous Histology After Prior Chemotherapy Treated in Real World Settings in Greece and Cyprus - The 'Lucence' Study

简要总结

主要结局

次要结局

• Proportion of participants surviving at the landmark timepoint 12 months after the initiation of nivolumab treatment, among the Non-Squamous Cell Carcinoma (NSCC) subpopulation(Up to 12 months)
• Proportion of participants surviving at the landmark timepoint 24 months after the initiation of nivolumab treatment, among the NSCC subpopulation(Up to 24 months)
• Proportion of participants surviving at the landmark timepoint 36 months after the initiation of nivolumab treatment, among the NSCC subpopulation(Up to 36 months)
• Proportion of participants surviving at the landmark timepoint 24 months after the initiation of nivolumab treatment per line of nivolumab treatment(Up to 24 months)
• Proportion of participants surviving at the landmark timepoint 24 months after the initiation of nivolumab treatment, among the SCC subpopulation(Up to 24 months)
• Proportion of participants surviving at the landmark timepoint 36 months after the initiation of nivolumab treatment, among the SCC subpopulation(Up to 36 months)
• Distribution of associations of baseline participant and disease characteristics with survival at 36 months post-treatment initiation(Up to 36 months)
• Change in the total LCSS score in the overall study population(Up to approximately 59 months)
• Distribution of Visits at office-based physicians for the management of treatment-related AEs, during the entire study observation period, in the overall study population(Up to approximately 59 months)
• Distribution of the number of nivolumab doses administered(Up to approximately 59 months)
• Time to onset of high-grade (Grade 3 or higher) immune-related adverse events (irAEs) per AE category(Up to approximately 59 months)
• Symptom improvement rate, at the post-baseline predefined timepoints, using the Lung Cancer Symptom Scale (LCSS) Average Symptom Burden Index (ASBI), in the overall study population(Up to approximately 59 months)
• Proportion of participants surviving at the landmark timepoint 12 months after the initiation of nivolumab treatment, among the Squamous Cell Carcinoma (SCC) subpopulation(Up to 12 months)
• Proportion of participants surviving at the landmark timepoint 12 months after the initiation of nivolumab treatment per line of nivolumab treatment(Up to 12 months)
• Proportion of participants surviving at the landmark timepoint 36 months after the initiation of nivolumab treatment per line of nivolumab treatment(Up to 36 months)
• Proportion of participants who have not progressed or died from any cause at the landmark timepoint 24 months after the initiation of nivolumab treatment(Up to 24 months)
• Proportion of participants who have not progressed or died from any cause at the landmark timepoint 36 months after the initiation of nivolumab treatment(Up to 36 months)
• Change in the total Average Symptom Burden Index (ASBI) score, in the overall study population(Up to approximately 59 months)
• Distribution of Hospital outpatient visits for the management of treatment-related AEs, during the entire study observation period, in the overall study population(Up to approximately 59 months)
• Distribution of Prescribed medications for the management of treatment-related AEs, during the entire study observation period, in the overall study population(Up to approximately 59 months)
• Distribution of Home visits by physicians, during the entire study observation period, in the overall study population(Up to approximately 59 months)
• Proportion of participants who have not progressed or died from any cause at the landmark timepoint 12 months after the initiation of nivolumab treatment(Up to 12 months)
• Proportion of participants with an investigator-assessed best overall response (BOR) of either a confirmed complete response (CR) or confirmed PR (ORR rate) at the landmark timepoint of 12 months after the initiation of nivolumab treatment(Up to 12 months)
• Time from start of nivolumab treatment to best response (e.g., if a participant had both PR and CR, time to CR), among participants who achieved at least PR(Up to approximately 59 months)
• Frequencies of baseline participant and disease characteristics of interest(Up to approximately 59 months)
• Distribution of the rate of dose modifications (including dose delays/withholdings)(Up to approximately 59 months)
• Distribution of the rate of permanent treatment discontinuation(Up to approximately 59 months)
• Time to resolution of high-grade (Grade 3 or higher) irAEs per AE category(Up to approximately 59 months)
• Distribution of type of adverse events leading to nivolumab treatment permanent discontinuation, in the overall study population(Up to approximately 59 months)
• Change in the total ASBI score throughout the study observation period examined using longitudinal analysis(Up to approximately 59 months)
• Proportion of participants with an investigator-assessed BOR of confirmed CR or PR or stable disease (SD) (DCR rate), at the landmark timepoint of 12 months after the initiation of nivolumab treatment(Up to 12 months)
• Time from start of nivolumab treatment to the first documented investigator-assessed response (CR or PR) (i.e., TTR), among participants who achieved at least PR(Up to approximately 59 months)
• Kaplan-Meier estimated median time from first documented response (CR or PR) to the date of first documented progression or death (due to any cause in the absence of progression), among participants who achieved at least PR (i.e., DoR)(Up to approximately 59 months)
• Kaplan-Meier estimated median time from best response (e.g., if a patient had both PR and CR, time from CR) to the date of first documented progression or death (due to any cause in the absence of progression), among patients who achieved at least PR(Up to approximately 59 months)
• Distribution of the frequencies of reasons for dose modifications/discontinuations(Up to approximately 59 months)
• Distribution of the types and frequencies of next treatment planned to be administered for NSCLC after nivolumab discontinuation(Up to approximately 59 months)
• Kaplan-Meier estimated time from nivolumab treatment initiation until discontinuation due to any reason(Up to approximately 59 months)
• Distribution of exposure-adjusted incidence rate (EAIR), severity (grade), and management of the specified types of treatment-related AEs in the overall study population(Up to approximately 59 months)
• Incidence of adverse events leading to nivolumab treatment permanent discontinuation, in the overall study population(Up to approximately 59 months)
• Change in the individual domain scores from baseline to each post-baseline predefined timepoint in the overall study population(Up to approximately 59 months)
• Change in the EuroQol (EQ-5D) utility index score, from baseline at the post-baseline predefined timepoints, in the overall study population(Up to approximately 59 months)
• Change in the EuroQol Visual Analogue Scale (EQ-VAS) score, from baseline at the post-baseline predefined timepoints, in the overall study population(Up to approximately 59 months)
• Change in the proportion of participants in the five-level version of the EuroQol five-dimensional questionnaire (EQ-5D-5L) dimension levels (no problems, with problems) from baseline at the post-baseline predefined timepoints(Up to approximately 59 months)
• Distribution of Emergency room attendances for the management of treatment-related AEs, during the entire study observation period, in the overall study population(Up to approximately 59 months)
• Distribution of Length of hospital stay, during the entire study observation period, in the overall study population(Up to approximately 59 months)
• Distribution of Person-time incidence rate (per 100 participant-weeks) of inpatient hospitalizations for the management of treatment-related AEs, during the entire study observation period, in the overall study population(Up to approximately 59 months)
• Distribution of Types and frequencies of medical procedures/interventions/diagnostic testing utilization, during the entire study observation period, in the overall study population(Up to approximately 59 months)