Osimertinib in poor PS patients with advanced NSCLC
- Conditions
- non-small-cell lung cancer
- Registration Number
- JPRN-jRCTs061180018
- Lead Sponsor
- Isobe Takeshi
- Brief Summary
The primary endpoint (ORR) was met statistically and the PS improvement rate was 54.5%. Osimertinib therapy was sufficiently effective for patients with T790M mutation-positive advanced NSCLC with EGFR-TKI resistance and a poor PS. In this study, all grades and grades 3-5 of Interstitial lung disease were observed in 15.2% (5/33) and 6.1% (2/33) of the patients, respectively. Treatment-related death due to interstitial lung disease occurred in one patient.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 33
(1) Pathologically or cytologically diagnosed advanced non-small-cell lung cancer
(2) Harboring EGFR active mutation
(3) Radiological progression was confirmed after 1st or 2nd generation EGFR-TKI
(4) T790M mutation was confirmed
(5) 5th or more days from the last dosage of EGFR-TKI
(6) Age over 20 years old
(7) ECOG PS 2-4
(8) With evaluable lesion
(9) Major organ function is satisfaction on registration in date from 14 days
(10) Written informed consent
(1) Patients with active double cancer for 5years
(2) Interstitial pneumonia
(3) Poor oral intake
(4) History of using immunocheckpoint therapy
(5) History of taking osimertinib medication
(6) The infection requiring systemic treatment
(7) Patients with psychosis or psychotic symptoms is determined to be difficult to participants in a clinical trial
(8) Patients with symptomatic brain metastases
(9) Uncontrolled diabetes
(10) Serious complications
(11) Patients during systemic administration steroids therapy over 4weeks
(12) Poor PS due to complication
(13) A pregnant woman, a woman in breast-fee
ding
(14)-(15) Patients with severe heart disease
(16) Prior radiotherapy for primary or metastasis evaluable lesion
(17) Patients with severe hypersensitivity
(18) Patients with corneal ulcer
(19) Not thorough observation promised
(20) An inappropriate case judged by doctor in charge
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method