This is an observational cohort study of patients with locally advanced or metastatic NSCLC (non-small cell lung cancer). Patients will be recruited from participating sites in Europe, Asia, and Canada. The study will include 2 patient cohorts.
Name: Patient Reported Outcomes
Description: HRQoL will be assessed using questionnaire EORTC QLQ-C30 and the questionnaire EORTC QLQ-LC 13. These two questionnaires are validated instruments, translated in various languages and are not used as an intervention but rather to track patient quality of life and symptom reduction in real-life settings. Data for these patient reported outcomes will be collected prospectively from the time of enrolment until the end of follow-up. The two questionnaires will be self-administered by the patients in both cohorts at the enrolment visit and subsequently every 3 months (±1 month) at routine standard of care scheduled visits. The questionnaires are expected to take about 15 minutes to completeType: OtherPatients newly diagnosed NSCLC Patients with EGFR mutation (+) NSCLC
Description: Molecular testing rate defined as the number of patients identified as having received molecular testing divided by the number of patients in the cohorts Changes in testing rates over time (details will be included in the SAP) Molecular testing details including, but not limited to sample type, method of biopsy, testing turnaround time, test type, reason for testing, testing laboratory type, reason for not performing a test Molecular testing results including mutation status and type, test outcome, histologic/phenotypic transformation
Measure: Parameters in the target population associate with molecular testing patters Time: Patients will be followed from enrolment in the study until death, loss to follow-up, withdrawal of consent or study end date. The minimum follow-up will be 12 months and the maximum allowed follow-up will be 36 monthsDescription: Overall survival measured from: the date of initial diagnosis to date of death from any cause to the index date to date of death from any cause (for primary cohort only) the date of first-line treatment until death the date of second-line treatment until death Overall disease progression: o from date of treatment initiation until physician-reported progression, initiation of a new cancer-directed line of therapy (proxy for progression), or death For each line of chemotherapy/targeted therapy received: Therapy regimen Therapy duration measured as time from therapy start date to time of therapy end date Number of cycles received Reason for cessation of therapy Time to initiation of new therapy defined as the time from start date of current therapy to start date of subsequent therapy For each surgery or radiotherapy received: Type Site Date Any palliative/supportive care received
Measure: Parameters in the target population associate with treatment patterns and associated clinical outcomes Time: Patients will be followed from enrolment in the study until death, loss to follow-up, withdrawal of consent or study end date. The minimum follow-up will be 12 months and the maximum allowed follow-up will be 36 monthsDescription: For each health care setting: Number and % of patients with visits Total number of visits Total length of inpatient hospital and ICU stay
Measure: Estimation of parameters in the target population associate with cancer-related health care utilization patters including inpatient, emergency room, outpatient visits, lenght of inpatient stay Time: Patients will be followed from enrolment in the study until death, loss to follow-up, withdrawal of consent or study end date. The minimum follow-up will be 12 months and the maximum allowed follow-up will be 36 monthsDescription: For each treatment complication: o Rate of occurrence defined as the number of patients reporting at least one treatment-related complications divided by the number of evaluable patients2 Treatment-related complications can include, but are not limited to nausea and vomiting, diarrhoea, constipation, skin rash, infections, mouth sores, neutropenia, hyponatremia For each biopsy-related complication: Rate of occurrence defined as the number of patients reporting at least one occurrence of the complication divided by the number of patients receiving a biopsy Biopsy-related complications can include but are not limited to collapsed lung, severe bleeding, bronchial spasms, irregular heart rhythms, death, severe chest pain, light-headedness, trouble breathing, excessive bleeding through the bandage, haemoptysis, fever, infection
Measure: Estimation of parameters in the target population associated with treatment- and biopsy-related complications Time: Patients will be followed from enrolment in the study until death, loss to follow-up, withdrawal of consent or study end date. The minimum follow-up will be 12 months and the maximum allowed follow-up will be 36 monthsDescription: Overall CNS metastases rate, defined as the number of patients developing CNS metastases divided by the number of evaluable patients Brain metastases rate, defined as the number of patients developing brain metastases divided by the number of evaluable patients Leptomeningeal metastases rate, defined as the number of patients developing leptomeningeal metastases divided by the number of evaluable patients Treatments for CNS metastases, including type of treatment and dates of treatment
Measure: Estimation of the rate of CNS metastases in the target population including brain metastases and leptomeningeal metastases and treatments associated with CNS metastases Time: Patients will be followed from enrolment in the study until death, loss to follow-up, withdrawal of consent or study end date. The minimum follow-up will be 12 months and the maximum allowed follow-up will be 36 monthsDescription: • Change in score from baseline for each Quality of Life (QoL) domain and for overall QoL, measured at each subsequent site visit
Measure: Assessment of patient (HRQoL) using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 items (EORTC QLQ-C30) and EORTC QLQ - Lung Cancer 13 items (EORTC QLQ-LC13)3 Time: Patients will be followed from enrolment in the study until death, loss to follow-up, withdrawal of consent or study end date. The minimum follow-up will be 12 months and the maximum allowed follow-up will be 36 monthsCohort
There is one SNP
Frequencies and percentages will be used to document categorical measures of interest (e.g., number and proportion of patients with a post progression molecular test, number and proportion of patients with a T790M mutation) and will include 95% CIs for key outcome variables. --- T790M ---