UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026669
Receipt number R000030552
Scientific Title A Phase 2 Study of Osimertinib for Advanced NSCLC with Malignant Pleural Effusion Harboring EGFR T790M mutation
Date of disclosure of the study information 2017/03/27
Last modified on 2018/02/19 22:41:08

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Basic information

Public title

A Phase 2 Study of Osimertinib for Advanced NSCLC with Malignant Pleural Effusion Harboring EGFR T790M mutation

Acronym

A Phase 2 Study of Osimertinib for Advanced NSCLC with Malignant Pleural Effusion Harboring EGFR T790M mutation

Scientific Title

A Phase 2 Study of Osimertinib for Advanced NSCLC with Malignant Pleural Effusion Harboring EGFR T790M mutation

Scientific Title:Acronym

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

1st name
Middle name
Last name Shinji Atagi

Organization

National hospital organization Kinki-chuo Chest Medical Center

Division name

thoracic oncology

Zip code


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

1st name
Middle name
Last name Shoko Sonobe

Organization

National hospital organization Kinki-chuo Chest Medical Center

Division name

internal medecine

Zip code


Address

1180, nagasone-cho, kita-ku, sakai-city, osaka

TEL

072-252-3021

Homepage URL


Email

sksonobe@kch.hosp.go.jp


Sponsor or person

Institute

The Japan-Multinational Trial Organization

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


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

Terminated

Date of protocol fixation

2017 Year 03 Month 07 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030552


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name