Non Small Cell Lung Cancer Clinical Trial
Official title:
T-STAR - T790M Mutation Positive 2nd Line STandard of cAre Registry
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
;
Observational Model: Cohort, Time Perspective: Prospective
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