EGFR mutation positive and T790M positive non-small cell lung cancer
Conditions
Interventions
1. Paraffin embedded specimen The specimen collected from a lesion at the confirmation of progression disease after osimertinib treatment is submitted with the specimen before osimertinib treatment.
Sponsors
Clinical Research Support Center Kyushu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Primary enrollment: The eligible patients are lung cancer patients whose formalin-fixed paraffin-embedded biopsy samples before osimertinib treatment are proven to have EGFR T790M mutation and who are planned to receive or receiving osimertinib treatment. The pre-treatment sample have to meet the "species and quantity of the sample" criteria. Secondary enrollment: Patients whose tumor tissue samples are available at the confirmation of progression disease after durable response to osimertinib treatment (documented PR/CR or SD for more than 6 months determined by RECIST or WHO criteria) and who are not started other anti-tumor treatment (chemotherapy, radiotherapy, immunotherapy) are eligible. Patients with adhesion therapy by minomycin, OK-432 and talc for coelomic fluid retention are also eligible. The sample have to meet the "species and quantity of the sample" criteria.
Exclusion criteria
Exclusion criteria: Patients who receive osimertinib concurrently with other cytotoxic agents, molecular targeting agents or immune-checkpoint inhibitors are excluded. Patients whose tumor specimens cannot meet the eligibility criteria or the "paired" specimens (pre and post osimertinib treatment) cannot be submitted are also excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gene analysis using next generation sequencing and protein expression analysis using immunohistochemistry | — |
Countries
Japan
Contacts
Public ContactAtsushi Osoegawa
Oita University Faculty of Medicine Department of Thoracic and Breast Surgery
Outcome results
None listed