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JAPANESE
国立保健医療科学院
JRCT ID: jRCTs041190027

Registered date:20/05/2019

A phase 2 study of afatinib for NSCLC with uncommon EGFR mutation detected by NGS

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedNon-small cell lung cancer with uncommon EGFR mutaiton
Date of first enrollment20/05/2019
Target sample size17
Countries of recruitment
Study typeInterventional
Intervention(s)Afatinib Dose: 40mg/day, orally once per day, until progression disease (or the meeting of discontinuation criteria)

Outcome(s)

Primary OutcomeObjective responce rate (ORR)
Secondary OutcomeProgression free survival (PFS), Overall survival (OS), safety

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteria1) Non-small cell lung cancer proven by histology and/or cytology 2) Confirmed diagnosis of stage III (not amenable for curative intent local radiotherapy), IV or postoperative/post chemoradiation therapy recurrence 3) single or compound uncommon EGFR mutaion detected by NGS with the exclusion of T790M mutaion or exon 20 insertion 4) 20 years or older 5) ECOG PS 0 or 1 6) No prior treatment with EGFR-TKI 7) At least one or more measurable lesion by RECIST 8) Adequate organ function 9) Written informed consent for translational research Written informed consent
Exclude criteria1) Patients with resistance EGFR mutations (T790M mutaion or exon 20 insertion) 2) Severe active infections 3) Severe diarrhea 4) Evidence of interstitial desease such as Idiopathic pulmonary fibrosis, pneumoconiosis and drug-induced pneumonitis 5) Patients unable to swallow oral medications 6) Under treatment of high-dose steroid therapy or immunosuppressive therapy 7) History of allergic reaction Decision of ineligibility by a physician 8) Prior treatment withimmune-checkpoint inhibitors within 3 months 9) Symptomatic brain metastasis/ leptomeningitis 10) Uncontrollable pleural, peritoneal or pericardial effusion 11) Prior palliative radiotherapy within 1weeks 12) Uncontrolled or severe hypertention, diabetes mellitus, active bleeding of the digestive tract, and known history of cardiovascular disease including congestive heart failure, myocardial infarction or unstable angina within 6 months. 13) No intention to birth control

Related Information

Contact

Public contact
Name Nobuaki Mamesaya
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan Shizuoka Japan 411-8777
Telephone +81-55-989-5222
E-mail n.mamesaya@scchr.jp
Affiliation Shizuoka cancer center
Scientific contact
Name Toshiaki Takahashi
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan Shizuoka Japan 411-8777
Telephone +81-55-989-5222
E-mail t.takahashi@scchr.jp
Affiliation Shizuoka cancer center