UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Phase 2 Study of Osimertinib for Advanced NSCLC with Malignant Pleural Effusion Harboring EGFR T790M mutation
Title of the study (Brief title)	A Phase 2 Study of Osimertinib for Advanced NSCLC with Malignant Pleural Effusion Harboring EGFR T790M mutation
Region	Japan

Condition
Condition	non-small cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The objective is to confirm the therapeutic effect and safety in monotherapy of Osimeltinib, third generation EGFR-TKI for EGFR T790M gene mutation-positive advanced nonsmall cell lung cancer combined with cancerous pleurisy, and to search for biomarkers.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Progression Free Survival
Key secondary outcomes	Objective Response Rate, Overall Survival, Pleural effusion Progression Free Survival, QOL(EORTC-QLQ-LC13), Safety, Biomarkers of blood and pleural effusion(VEGF, FGF2, CXCL12, HGF)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Osimertinib
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Diagnosis of Stage4 NSCLC with malignant pleural effusion 2)Pleural effusion requiring at least manual drainage treatment 3)Cytology in pleural effusion is positive 4)Cases with at least one measurable lesion that can be evaluated with RECIST ver.1.1 5) EGFR-TKI susceptibility gene at diagnosis Positive mutation EGFR gene mutation positive Example: with exon 19 deletion or L858R Exclude double mutation cases with EGFR minor mutation 6) Cases with treatment with at least one or more first generation or second generation EGFR-TKI Enable past history of cytokide anti-cancer drug 7) When progression of a pathological condition is imagewise observed from pretreatment 8)A case in which a case of T790M gene mutation positive was confirmed by an approved diagnostic method 9)When the registration age is over 20 years old 10)When the performance status (WHO Scale)is 0-2 11)When the following major organ abilities are held at the examination price within 7 days before registration Number of neutrophils:1,500/mm3 or more Platelet count:100,000/mm3 or more Hemoglobin:9.0g/dl or more AST(GOT), ALT(GPT):100IU/L or less Total bilirubin:1.5mg/dL or less Serum creatinine value:1.5mg/dl or less 12)Cases satisfying SpO2 more than 90% before pleural drainage 13)Cases in which survival can be expected for 12 weeks or more from the administration start date 14)In the case of men, for example, when using a contraceptive method using condoms 15)In case of a fertile woman, if appropriate contraceptive measures are taken 16)When consent is obtained from the patient himself for participation of this research
Key exclusion criteria	1) Patients with a history of severe allergy or hypersensitivity to the ingredients of the drugs used 2) Cases with pleurodesis 3) Case of treatment history of Osimeltinib and other third generation EGFR-TKI 4) Patients treated with immune checkpoint inhibitors 5) Cases with major surgery within 4 weeks 6) Patients who are concomitantly taking drugs with strong inducing action on cytochrome P450 (CYP) 3A4 or supplements of Chinese traditional herbs (or patients who can not be discontinued at least 1 week before the first dose) 7) Cases with complications of malignancy and / or other active malignant tumors requiring treatment within one year prior to the first dose 8) Cases with serious complications 9) Examples of symptomatic brain metastasis and spinal cord pressure exclusion (cases that can be controlled by treatment can be registered) 10) Cases with obvious interstitial pneumonia or pulmonary fibrosis in chest CT or cases with a history of interstitial pneumonia 11) Patients with a history of gastrointestinal resection such as refractory nausea and vomiting, chronic gastrointestinal disorder, inability to swallow or absorption possibly significantly affecting absorption of osimertinib 12) Case in which QTc value is 470 msec or more in electrocardiogram examination at screening 13) Case with corneal ulcer 14) Cases with difficult ingestion 15) Pregnant women or lactating women 16) Other cases, cases in which doctor in charge judged inappropriate as the subject of this study (examples where dementia patients or psychiatric patients are difficult to perform the test)
Target sample size	25

Research contact person
Name of lead principal investigator	Shinji Atagi
Organization	National hospital organization Kinki-chuo Chest Medical Center
Division name	thoracic oncology
Address	1180, nagasone-cho, kita-ku, sakai-city, osaka
TEL	072-252-3021
Email	s-atagi@kch.hosp.go.jp

Public contact
Name of contact person	Shoko Sonobe
Organization	National hospital organization Kinki-chuo Chest Medical Center
Division name	internal medecine
Address	1180, nagasone-cho, kita-ku, sakai-city, osaka
TEL	072-252-3021
Homepage URL
Email	sksonobe@kch.hosp.go.jp

Sponsor
Institute	The Japan-Multinational Trial Organization
Institute
Department

Funding Source
Organization	AstraZeneca plc
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 27 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 03 Month 07 Day
Anticipated trial start date	2017 Year 04 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 03 Month 23 Day
Last modified on	2018 Year 02 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030552