PD-L1 and Other Immuno-markers Influenced by Osimertinib Treatment in Advanced NSCLC Patients

Study Overview
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Brief Summary
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The study will investigate whether PD-L1 and other immuno-markers will be influenced by osimertinib treatment in advanced epidermal growth factor receptor （EGFR）T790M positive advanced NSCLC patients. In addition, we will explore whether PD-L1 and other immuno-markers can predict the safety and efficacy of subsequent use of immune checkpoint inhibitors at the time of PD due to osimertinib resistance.

Detailed Description
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Investigate whether PD-L1 and other immuno-markers will be influenced by osimertinib treatment in advanced EGFR T790M positive advanced NSCLC patients. explore whether PD-L1 and other immuno-markers can predict the safety and efficacy of subsequent use of immune checkpoint inhibitors at the time of PD due to osimertinib resistance.

Official Title
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Programmed Death-ligand 1(PD-L1) and Other Immuno-markers Influenced by Osimertinib Treatment in Advanced Non-small Cell Lung Cancer (NSCLC) Patients

Conditions
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Small Cell Lung Cancer, Polygonal Type

Intervention / Treatment
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* Other: No interventions will be taken in this Observational study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient enrolled in ASTRIS or patient who are eligible for the ASTRIS study. The patient is willing to provide informed consent form to provide specimen before osimertinib treatment and at the time of PD. Patients must be able to undergo a fresh tumor biopsy during screening or to provide an available tumor sample taken <2 months prior to screening. Fine needle aspirate specimens are not acceptable. Specimens from metastatic bone lesions are typically unacceptable unless there is confirmed soft tissue component. The tumor specimen submitted to establish eligibility should be of sufficient quantity to allow for PD-L1 IHC and other biomarker analyses (if applicable) and is preferred in formalin-fixed paraffin embedded blocks. Exclusion Criteria: The patient does not have sufficient tumor tissue specimen available for detection. The Patient who is unwilling to use the existing data from medical practice for scientific research. The patient who received immunotherapy therapy before.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No interventions will be taken in this Observational study|TAGRISSO(osimertinib/AZD9291）|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure PD-L1 value | Measure PD-L1 value Change by tumor cells（TC）/immune cells(IC) staining from the baseline to progressive disease（PD） | baseline and PD，up to 24 months | 
| Measure PD-L1 expression positive rate (%) | Measure PD-L1 expression positive rate (%) change from the baseline to progressive disease（PD） | baseline and PD，up to 24 months |