Prospective observational study for Treatment resistance related gene screening using plasma circulating tumor DNA in the third generation EGFR-TKI Osimertinib therapy

JRCT ID: jRCTs031180051

Registered date:10/12/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Non small cell lung cancer harboring EGFR mutation
• Date of first enrollment: 10/12/2018
• Target sample size: 180
• Study type: Interventional
• Intervention(s): Blood sampling (every 30ml) x5

Outcome(s)

• Primary Outcome: Osimertinib treatment resistance-related genetic mutation's incidence and ratio by the high sensitive next-generation sequence method using ctDNA at before osimertinib treatment and deisease progression

Secondary Outcome

1) An incidence and ratio of resistance-related gene (mutation) treated with osimertinib with the next generatiom sequencer using the tumour tissue DNA before and after progression of osimertinib if specimen presentation is possible
2) When possible, an incidence and ratio of resistance-related gene (mutation) treated with osimertinib with hypersinsitive next-generation sequence method in ctDNA at three months and 12 months after osimertinib administration
3) To examine how the detection quantity of the resistance-related gene (mutation) treated with osimertinib with hypersinsitive next-generation sequence method in ctDNA at three months and 12 months after osimertinib administration influences condition progress under treatment the osimertinib, if possible
4) To check the sensitive and specific rate of the results (the incidence and rate of the resistance-related gene (mutation)) between using hypersinsitive next-generation sequence method in ctDNA and using the next generatiom sequencer using the tumour tissue DNA
5) To examine background factor and the the resistance-related gene (mutation) of osimertinib treatment in the case of disease rogression at three months and 12 months after osimertinib treatment, and examine the factor which influenced disesase progression exploratorily

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Cases in which a definitive diagnosis of non-squamous non-small cell lung cancer has been obtained by histological examination or cytological examination.
2) Cases of inoperable or recurrent non-small cell lung cancer positive for EGFR-TKIs susceptibility gene mutation.
3) Cases in which osimertinib monotherapy is used as the initial treatment.
4) Plasma samples can be submitted.
5) Written consent has been obtained.

Exclude criteria

1) Cases that the doctor in charge deems inappropriate for this study
2) Cases with experience of allogeneic bone marrow transplantation
3) Cases scheduled for non-leukocyte depletion whole blood transfusion
4) Cases where the consent of the person cannot be obtained
5) Minors under the age of 20
6) Cases of inoperable or recurrent non-small cell lung cancer with negative EGFR-TKIs susceptibility gene mutations (without exon19del, exon21L858R)
7) Cases less than 1 year after postoperative chemotherapy
8) Cases of treatment containing drugs other than osimertinib

Related Information

• Primary Sponsor: Tamiya Akihiro
• Secondary Sponsor: AstraZeneca,National hospital organization