The purpose of this observational study is to estimate the overall survival (OS) rates in the overall study population treated with nivolumab in the second and third line setting in real world clinical practice in Greece and Cyprus. The study is descriptive in nature and is not planned to reject or affirm any formal statistical hypothesis.
Study Type
OBSERVATIONAL
Enrollment
212
Local Institution - 0002
Stróvolos, Cyprus
Local Institution - 0001
Athens, Greece
Proportion of participants surviving at the landmark timepoint of 12 months after the initiation of nivolumab treatment, in the overall study population
Time frame: Up to 12 months
Proportion of participants surviving at the landmark timepoint of 24 months after the initiation of nivolumab treatment, in the overall study population
Time frame: Up to 24 months
Proportion of participants surviving at the landmark timepoint of 36 months after the initiation of nivolumab treatment, in the overall study population
Time frame: Up to 36 months
Proportion of participants surviving at the landmark timepoint 12 months after the initiation of nivolumab treatment, among the Squamous Cell Carcinoma (SCC) subpopulation
Time frame: Up to 12 months
Proportion of participants surviving at the landmark timepoint 24 months after the initiation of nivolumab treatment, among the SCC subpopulation
Time frame: Up to 24 months
Proportion of participants surviving at the landmark timepoint 36 months after the initiation of nivolumab treatment, among the SCC subpopulation
Time frame: Up to 36 months
Proportion of participants surviving at the landmark timepoint 12 months after the initiation of nivolumab treatment, among the Non-Squamous Cell Carcinoma (NSCC) subpopulation
Time frame: Up to 12 months
Proportion of participants surviving at the landmark timepoint 24 months after the initiation of nivolumab treatment, among the NSCC subpopulation
Time frame: Up to 24 months
Proportion of participants surviving at the landmark timepoint 36 months after the initiation of nivolumab treatment, among the NSCC subpopulation
Time frame: Up to 36 months
Proportion of participants surviving at the landmark timepoint 12 months after the initiation of nivolumab treatment per line of nivolumab treatment
Time frame: Up to 12 months
Proportion of participants surviving at the landmark timepoint 24 months after the initiation of nivolumab treatment per line of nivolumab treatment
Time frame: Up to 24 months
Proportion of participants surviving at the landmark timepoint 36 months after the initiation of nivolumab treatment per line of nivolumab treatment
Time frame: Up to 36 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
Time frame: Up to 12 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
Time frame: 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
Time frame: Up to 36 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
This refers to the overall study population, the SCC and NSCC subpopulations, and the subpopulations per line of nivolumab treatment.
Time frame: Up to 12 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
This refers to the overall study population, the SCC and NSCC subpopulations, and the subpopulations per line of nivolumab treatment.
Time frame: 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
This refers to the overall study population, the SCC and NSCC subpopulations, and the subpopulations per line of nivolumab treatment.
Time frame: Up to approximately 59 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
This refers to the overall study population, the SCC and NSCC subpopulations, and the subpopulations per line of nivolumab.
Time frame: 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)
This refers to the overall study population, the SCC and NSCC subpopulations, and the subpopulations per line of nivolumab.
Time frame: 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
This refers to the overall study population, the SCC and NSCC subpopulations, and the subpopulations per line of nivolumab.
Time frame: Up to approximately 59 months
Frequencies of baseline participant and disease characteristics of interest
This refers to the overall study population and the SCC and NSCC subpopulation.
Time frame: Up to approximately 59 months
Distribution of associations of baseline participant and disease characteristics with survival at 36 months post-treatment initiation
Time frame: Up to 36 months
Distribution of the number of nivolumab doses administered
This refers to the overall study population, the SCC and NSCC subpopulations, and the subpopulations per line of nivolumab treatment.
Time frame: Up to approximately 59 months
Distribution of the rate of dose modifications (including dose delays/withholdings)
This refers to the overall study population, the SCC and NSCC subpopulations, and the subpopulations per line of nivolumab treatment.
Time frame: Up to approximately 59 months
Distribution of the rate of permanent treatment discontinuation
This refers to the overall study population, the SCC and NSCC subpopulations, and the subpopulations per line of nivolumab treatment.
Time frame: Up to approximately 59 months
Distribution of the frequencies of reasons for dose modifications/discontinuations
This refers to the overall study population, the SCC and NSCC subpopulations, and the subpopulations per line of nivolumab treatment.
Time frame: Up to approximately 59 months
Distribution of the types and frequencies of next treatment planned to be administered for NSCLC after nivolumab discontinuation
This refers to the overall study population, the SCC and NSCC subpopulations, and the subpopulations per line of nivolumab treatment.
Time frame: Up to approximately 59 months
Kaplan-Meier estimated time from nivolumab treatment initiation until discontinuation due to any reason
This refers to the overall study population, the SCC and NSCC subpopulations, and the subpopulations per line of nivolumab treatment.
Time frame: 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
Time frame: Up to approximately 59 months
Time to onset of high-grade (Grade 3 or higher) immune-related adverse events (irAEs) per AE category
Time frame: Up to approximately 59 months
Time to resolution of high-grade (Grade 3 or higher) irAEs per AE category
Time frame: Up to approximately 59 months
Incidence of adverse events leading to nivolumab treatment permanent discontinuation, in the overall study population
Time frame: Up to approximately 59 months
Distribution of type of adverse events leading to nivolumab treatment permanent discontinuation, in the overall study population
Time frame: Up to approximately 59 months
Change in the total LCSS score in the overall study population
Time frame: Up to approximately 59 months
Change in the total ASBI score throughout the study observation period examined using longitudinal analysis
Time frame: Up to approximately 59 months
Change in the total Average Symptom Burden Index (ASBI) score, in the overall study population
In addition, change in the total ASBI score throughout the study observation period will be examined using longitudinal analysis
Time frame: Up to approximately 59 months
Change in the individual domain scores from baseline to each post-baseline predefined timepoint in the overall study population
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
in the overall study population
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to approximately 59 months
Distribution of Home visits by physicians, during the entire study observation period, in the overall study population
Time frame: Up to approximately 59 months
Distribution of Length of hospital stay, during the entire study observation period, in the overall study population
Time frame: 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
Time frame: 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
Time frame: Up to approximately 59 months
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