UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015552
Receipt number R000018071
Scientific Title The feasibility study and biomarker research of afatinib in patients with previously treated advanced NSCLC harboring EGFR mutation
Date of disclosure of the study information 2014/10/28
Last modified on 2014/10/28 19:57:08

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Basic information

Public title

The feasibility study and biomarker research of afatinib in patients with previously treated advanced NSCLC harboring EGFR mutation

Acronym

The feasibility study and biomarker research of afatinib in patients with previously treated advanced NSCLC harboring EGFR mutation

Scientific Title

The feasibility study and biomarker research of afatinib in patients with previously treated advanced NSCLC harboring EGFR mutation

Scientific Title:Acronym

The feasibility study and biomarker research of afatinib in patients with previously treated advanced NSCLC harboring EGFR mutation

Region

Japan


Condition

Condition

Non-small cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the efficacy and safety of afatinib in patients with previously treated advanced NSCLC harboring EGFR mutation, and to analyze the biomarker of afatinib

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Response rate (RR)

Key secondary outcomes

Disease control rate (DCR), Progression free survival (PFS), Overall survival (OS), Safety and Biomarker research of afatinib


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

Afatinib 40mg/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) Histologically and/or cytologically proven NSCLC
2) Unresectable clinical stage IIIB/IV
3) Patients who have sensitive EGFR mutation (exon19 deletion, exon21 L858R)
4) Previous treated with platinum combination chemotherapy and EGFR-TKI (gefitinib or erlotinib), or the platinum combination chemotherapy is unacceptable
5) Measurable or evaluable disease for RECIST
6) Age: over 20
7) PS (ECOG): 0-2
8) Adequate organ functions judged by laboratory tests
9) Life expectancy: over 3 months
10) Written informed consent

Key exclusion criteria

1) Patient with serious disease condition (interstitial pneumonia, lung fibrosis, pneumoconiosis, drug-induced pneumonia, radiation pneumonitis)
2) Patient with much ascetic fluid, pleural effusion, cardiac effusion.
3) Patient with active infection
4) Pregnancy
5) Symptomatic brain metastases
6) Patient with active double cancer
7) Considered as unfit to study drug administration by attending doctor according to clinical symptoms or laboratory abnormalities.
8) Considered to be interfere to the agreement or understanding the protocol by attending doctor.

Target sample size

45


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshiki Ishii

Organization

Dokkyo Medical University

Division name

Department of Pulmonary Medicine and Clinical Immunology

Zip code


Address

880 Kitakobayashi, Mibu, Tochigi, Japan

TEL

0282-87-2151

Email

ishiiysk@dokkyomed.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ryo Arai

Organization

Dokkyo Medical University

Division name

Department of Pulmonary Medicine and Clinical Immunology

Zip code


Address

880 Kitakobayashi, Mibu, Tochigi, Japan

TEL

0282-87-2151

Homepage URL


Email

r-arai@dokkyomed.ac.jp


Sponsor or person

Institute

Dokkyo Medical University

Institute

Department

Personal name



Funding Source

Organization

Dokkyo Medical University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Tochigi-kitakan Thoracic Oncology Research Organization (TOTORO)

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

2014 Year 10 Month 28 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

2014 Year 08 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 10 Month 28 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

2014 Year 10 Month 28 Day

Last modified on

2014 Year 10 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018071


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name