Osimertinib in poor PS patients with advanced NSCLC

JRCT ID: jRCTs061180018

Registered date:31/01/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: non-small-cell lung cancer
• Date of first enrollment: 14/02/2017
• Target sample size: 32
• Study type: Interventional
• Intervention(s): Osimertinib 80 mg/day

Outcome(s)

• Primary Outcome: Objective Response Rate

Secondary Outcome

(1) Disease Control Rate
(2) Time to Treatment Failure
(3) Progression-Free Survival
(4) Overall Survival
(5) Rate of patients improved PS score by one and more
(6) Safety and Tolerability

Key inclusion & exclusion criteria

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

Include criteria

(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

Exclude criteria

(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

Related Information

• Primary Sponsor: Isobe Takeshi
• Secondary ID(s): UMIN000023823