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

JRCT ID: jRCTs041190027

Registered date:20/05/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Non-small cell lung cancer with uncommon EGFR mutaiton
• Date of first enrollment: 20/05/2019
• Target sample size: 17
• Study type: Interventional
• Intervention(s): Afatinib Dose: 40mg/day, orally once per day, until progression disease (or the meeting of discontinuation criteria)

Outcome(s)

• Primary Outcome: Objective responce rate (ORR)
• Secondary Outcome: Progression free survival (PFS), Overall survival (OS), safety

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: 1) 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 criteria: 1) 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

• Primary Sponsor: Takahashi Toshiaki
• Secondary Sponsor: Hirotsugu Kenmotsu
• Source(s) of Monetary Support: Nippon Boehringer Ingelheim Co ., Ltd