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

JRCT ID: jRCT1041180081

Registered date:12/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: EGFR mutation T790M-positive non-small-cell lung cancer
• Date of first enrollment: 17/08/2017
• Target sample size: 18
• Study type: Interventional
• Intervention(s): Administeration of 80 mg osimertinib once daily

Outcome(s)

• Primary Outcome: Progression free survival
• Secondary Outcome: Safety, Response rate, Improvement rate of performance status, Overall survival

Key inclusion & exclusion criteria

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

Include criteria

1)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 criteria

1)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

• Primary Sponsor: Murakami Haruyasu
• Secondary ID(s): UMIN000027655