UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000023710
Receipt number	R000027314
Scientific Title	A multicenter, single arm phase 2 study to examine efficacy and cerebrospinal fluid transitivity of Osimertinib in leptomeningeal carcinomatosis (LMC) patients with non-small cell lung cancer harboring EGFR mutation
Date of disclosure of the study information	2016/10/01
Last modified on	2016/10/03 08:04:44

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Basic information

Public title

A multicenter, single arm phase 2 study
to examine efficacy and cerebrospinal fluid transitivity of Osimertinib
in leptomeningeal carcinomatosis (LMC) patients
with non-small cell lung cancer harboring EGFR mutation

Acronym

A phase 2 study of Osimertinib in LMC

Scientific Title

Scientific Title:Acronym

A phase 2 study of Osimertinib in LMC

Region

Japan North America

Condition

leptomeningeal carcinomatosis (LMC) patients with non-small cell lung cancer harboring EGFR mutation

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES

Objectives

Narrative objectives1

The purpose of this study is to evaluate efficacy and safety of Osimertinib in patients with lung cancer harboring EGFR mutation and metastasis to leptomeningeal carcinomatosis. This study is also conducted as a translational research to evaluate transitivity ofOsimertinib.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

1.Progression-free survival
2.Cerebrospinal fluid transitivity of osimertinib

Key secondary outcomes

1.ORR, DCR, OS, Safety profile
2.QOL Evaluation (EORTC QLQ-C30)
3.Change of neurological finding (Neurologogical exam)
4.CNS-RR,CNS-DCR,CNS-PFS
5.To explore a resistance factor

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

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Osimertinib 80 mg/day

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.Patients with non-small cell lung cancer diagnosed histologically or cytologically (except SCC)
2.Patients with EGFR gene mutation
3.Patients who shows acquired EGFR-TKI resistance. Patients resistant to a regimen of EGFR-TKI + other drug can also be enrolled
4.Patients with documented EGFR exon 20 T790M mutation in any lesion when EGFR-TKI failure
5.Patients who are detected;
-cytologically positive in CSF
-EGFR gene mutation positive in CSF
If both negative image can be confirmed as LMC with;
1:findings of thickened dura mater
2:image with exudation of contrast medium
and attending doctor and clinical study officer as central review are confirmed.
6.For patients who received radiotherapy, time defined below has been passed from the last radiotherapy till their enrollment to the present study
[1]Radiotherapy to lung field - over 4 weeks
[2]Radiotherapy to whole brain or whole spinal marrow
7.Patients aged 20 years or more at informed consent
8.PS 0 to 2
9.Patients with maintaining sufficient functioning of major organs
10.Three weeks has passed since the last dose of cytotoxic anticancer drug
11.expected survival of not less than 3 months from start of the study treatment
12.Patients who were fully explained about the study and submitted written informed consent before enrollment
13.Desirably, patients have measurable or evaluable lesion according to definition in RECIST (Ver. 1.1), but this criterion is not mandatory.

Key exclusion criteria

1.Patients with interstitial pneumonia or lung fibrosis clearly demonstrated by chest CT
2.Patients with a history of serious drug allergy
3.Patients with any serious infectious disease or other serious concurrent medical condition (e.g., gastrointestinal hemorrhage)
4.Patients with high amount of or uncontrollable pleural effusion, ascites or pericardial effusion
-If patients treat synechia with anticancer drugs who can participate in the study
5.Patients with any clinically problematic heart disease (e.g., uncontrollable arrhythmia/angina, cardiac failure)
6.Patients with uncontrollable diabetes mellitus concurrently
7.Patients with active double cancer
8.Patients with any clinically problematic psychiatric disorder
9.Patients with untreated fracture (except compression fracture associated with osteoporosis) or severe wound
10.Pregnant, lactating or possibly pregnant female patients, or patients reluctant to take an effective contraceptive measure
11.Patients have immuno-checkpoint inhibitor as previous treatment
12.Other patients who, in the opinion of the investigator, are not eligible for participation in the present study for any reason

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Nobuyuki Katakami

Organization

Institute of Biomedical Research and Innovation

Division name

Integrated Onclogy

Zip code

Address

2-2, Minatojima-Minamimachi, Chuo-ku, Kobe

TEL

0783045200

Email

katakami@fbri.org

Public contact

Name of contact person

1st name

Middle name

Last name Shigeki Nanjo, Akito Hata

Organization

Institute of Biomedical Research and Innovation

Division name

Integrated Onclogy

Zip code

Address

2-2, Minatojima-Minamimachi, Chuo-ku, Kobe

TEL

078-304-5200

Homepage URL

Email

a-hata@fbri.org

Sponsor or person

Institute

HANSHIN

Institute

Department

Personal name

Funding Source

Organization

Astra Zeneca

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Other related organizations

Co-sponsor

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Address

Tel

Email

Secondary IDs

YES

Study ID_1

HANSHIN0216

Org. issuing International ID_1

HANSHIN

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

明石医療センター呼吸器内科
大阪府立成人病センター呼吸器内科
金沢大学附属病院がんセンター
関西医科大学附属病院呼吸器腫瘍内科
京都桂病院呼吸器内科
倉敷中央病院呼吸器内科
神戸大学医学部附属病院呼吸器内科
先端医療センター総合腫瘍科
宝塚市立病院腫瘍内科
刀根山病院呼吸器腫瘍内科
兵庫県立がんセンター呼吸器内科

Other administrative information

Date of disclosure of the study information

2016 Year 10 Month 01 Day

Related information

URL releasing protocol

Publication of results

Unpublished

Result

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2016 Year 08 Month 19 Day

Date of IRB

Anticipated trial start date

2016 Year 10 Month 03 Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Management information

Registered date

2016 Year 08 Month 22 Day

Last modified on

2016 Year 10 Month 03 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027314

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

1st name
Middle name
Last name	Shigeki Nanjo, Akito Hata