The aim of the study is to collect real world information on patients with locally advanced or metastatic non small cell lung cancer (NSCLC) who progressed after first line treatment with an approved Tyrosine-Kinase Inhibitor (TKI), who are known to be T790M positive and have been prescribed second line platinum-based chemotherapy (Pemetrexed + Cisplatin /Carboplatin).
The study is an observational prospective cohort study that plans to enroll approximately 200 patients worldwide. There are Epidermal Growth Factor Receptor (EGFR) mutations known to be associated with EGFR-targeted TKI sensitivity ( Ex19Del, L858R, L861Q, and G719X). Further tests on biopsied tissue or cytology at progression after treatment with an approved EGFR targeted TKI are used to determine positivity to T790M mutation. Primary objectives of the study are : * To estimate overall survival * To estimate disease progression (as assessed and defined by physician) * To estimate time on treatment by line of therapy * To describe time to subsequent therapies (or death) * To describe healthcare resource utilization patterns * To capture patient reported symptoms, functioning, and health-related quality of life (HRQoL) data using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 items (EORTC QLQ-C30) and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 13 items (EORTC QLQ-LC13) * To describe the use of pemetrexed + cisplatin/carboplatin as the 2nd line treatment * To describe treatment patterns for 3rd line treatment and beyond
Study Type
OBSERVATIONAL
Overall Survival
This will be assessed as the time from the start date of 2nd line chemotherapy until death due to any cause or censoring (at end of 24 months).To assess efficacy of permetrexed + cisplatinum/carboplatin as the 2nd line of treatment of NSCLC.
Time frame: 24 months from last subject in
Response to Therapy as assessed by the physician
This will be assessed as the time from start of 2nd line therapy until the date of disease progression or death (by any cause in the absence of progression). To assess efficacy of 2nd line treatment and beyond.
Time frame: 24 months from last subject in
Time on treatment by line of therapy and between therapies
This will be assessed as the time from start date of line of therapy to end date of line of therapy or death date. To describe treatment patterns for 2nd line and beyond.
Time frame: 24 months from last subject in
Admission of planned/unplanned hospitalizations, emergency department visits and outpatient/physician visits
This will be assessed as the number and Time from the dates of admission and exit of attendance. To describe Healthcare resource utilization for 2nd line treatment and beyond.
Time frame: 24 months from last subject in
Time to symptom deterioration
For each of the symptoms in EORTC QLQ-LC13 and EORTC QLQ-C30, Time from inclusion until the date of first clinically meaningful symptom deterioration or death by any cause in the absence of a clinically meaningful symptom deterioration. To assess the impact of 2nd and subsequent lines of therapy on patients' disease-related symptoms and health related quality of life.
Time frame: 24 months from last subject in
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Research Site
Kentucky, Kentucky, United States
Research Site
Maryland City, Maryland, United States
Research Site
Langhorne, Pennsylvania, United States
Research Site
Beijing, China
Research Site
Changsha, China
Research Site
Guangzhou, China
Research Site
Jiangsu, China
Research Site
Jilin, China
Research Site
Shanghai, China
Research Site
Shanghai Ruijin Hospital, China
...and 39 more locations
Symptom Improvement Rate
This will be assessed as the number of patients with two consecutive assessments, which showed a clinically meaningful improvement in that symptom from baseline. To assess the impact of 2nd and subsequent lines of therapies on patients' disease-related symptoms and health related quality of life.
Time frame: 24 months from last subject in
Duration of Response as defined by the physician
This will be assessed as the time from the date of complete or partial response until the first date of recurrence or progression. To assess the efficacy of 2nd line treatment and beyond.
Time frame: 24 months from last subject in
Progression Free Survival
This will be assessed as the time from start of 2nd line therapy until the date of disease progression or death by any cause. This will be done to assess efficacy of pemetrexed + cisplatin/carboplatin as the 2nd line treatment of NSCLC.
Time frame: 24 months from last subject in