NIPH Clinical Trials Search

JRCT ID: jRCT1041180081

Registered date:12/03/2019

A phase II study of osimertinib in patients with poor performance status and non-small-cell lung cancer

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedEGFR mutation T790M-positive non-small-cell lung cancer
Date of first enrollment17/08/2017
Target sample size18
Countries of recruitment
Study typeInterventional
Intervention(s)Administeration of 80 mg osimertinib once daily


Primary OutcomeProgression free survival
Secondary OutcomeSafety, Response rate, Improvement rate of performance status, Overall survival

Key inclusion & exclusion criteria

Age minimum20age old
Age maximumNot applicable
Include criteria1)ECOG PS 2, 3, or 4 2)Pathologically confirmation of non squamous non-small-cell lung cancer 3)Advanced non-small-cell lung cancer 4)History of using first-generation or second-generation EGFR-TKI 5)EGFR mutation with T790M in exon 20 6)Aged 20 or more 7)Written informed consent
Exclude criteria1)History of using third-generation EGFR-TKI 2)Uncontrolled symptomatic brain metastasis 3)Interstitial pneumonia or pulmonary fibrosis on imaging 4)QTc > 500 msec 5)Gastrointestinal disorder 6)Uncontrollable pleural effusion , ascites or pericardial effusion 7)Receiving the radiation therapy for chest 8)Severe complication

Related Information


Public contact
Name Kazuhisa Nakashima
Address 89-1 Enya-cho Izumo-shi, Shimane, Japan Shimane Japan 693-8501
Telephone +81-853-20-2580
Affiliation Shimane University Faculty of Medicine
Scientific contact
Name Haruyasu Murakami
Address 1007 Shimonagakubo Nagaizumi-cho Sunto-gun, Shizuoka, Japan Shizuoka Japan 411-8777
Telephone +81-55-989-5222
Affiliation Shizuoka Cancer Center