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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000015414
Receipt No. R000017924
Scientific Title Exploratory clinical study of first-line treatment for patients with advanced EGFR mutation-positive non-squamous non-small-cell lung cancer
Date of disclosure of the study information 2014/10/11
Last modified on 2018/04/16

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Basic information
Public title Exploratory clinical study of first-line treatment for patients with advanced EGFR mutation-positive non-squamous non-small-cell lung cancer
Acronym Exploratory clinical study of first-line treatment for patients with advanced EGFR mutation-positive non-squamous non-small-cell lung cancer
Scientific Title Exploratory clinical study of first-line treatment for patients with advanced EGFR mutation-positive non-squamous non-small-cell lung cancer
Scientific Title:Acronym Exploratory clinical study of first-line treatment for patients with advanced EGFR mutation-positive non-squamous non-small-cell lung cancer
Region
Japan

Condition
Condition advanced EGFR mutation-positive non-squamous non-small cell lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology Adult
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Prior to the initiation of treatment for advanced or postoperative recurrence EGFR mutation-positive non-squamous non-small cell lung cancer, we ask questions on the treatment to the patients. We select the treatment that the patient desires, to assess the efficacy and safety.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Progression free survival
Key secondary outcomes Overall survival, Response rate, Adverse events, QOL

Base
Study type Interventional

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

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 EGFR-TKI monotherapy (gefitinib, erlotinib or afatinib)
Interventions/Control_2 maintenance therpy of gefitinib plus pemetrexed after gefitinib, carboplatin plus pemetrexed concurrent therapy
Interventions/Control_3 erlotinib plus bevacizumab therapy involving the insertion of the bevacizumab, cisplatin plus pemetrexed combination therapy
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.Cytologically or histologically documented non-squamous non-small cell lung cancer
2.EGFR activating mutation positive
3.Stage III without any indications for radiotherapy, Stage IV, or postoperative recurrence
4.chemotherapy naive
5.Prior palliative radiotherapy
1)Except to the primary pulmonary lesion
2)more than two weeks after palliative radiotherapy for bone metastasis
6.Evaluable lesions (Measuarable lesions are not necessary)
7.20 years of age or older at the time of consent
8.ECOG PS 0-1
9.Have adequate organ function within two weeks before study entry
10.Have signed an informed consent
11.Estimated life expectancy of at least 3 months
Key exclusion criteria 1.EGFR mutation Exon20 T790M positive
2.Symptomatic brain metastasis and a spinal metastases requiring surgical treatment or irradiation
3.Less than 5 years of disease-free interval with other malignancy
4.Pleural effusion, ascites or pericardial fluid in need of treatment
5.SVC syndrome
6.Spinal cord compression with symptoms
7.Cerebrovascular disorder with aymptoms
8.Unhealed fracture
9.Severe infection
10.Planned surgery during the study period
11.Obvious interstitial lung disease
12.Severe gastrointestinal disorder
13.Symptomatic corneal disease
14.Severe cardiac disease
15.Clinically significant drug allergy
16.Prior EGFR-TKI therapy
17.During pregnabcy or lactating woman
18.Uncontrolled psychiatric disease
19.Other
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fumio Imamura
Organization Osaka Medical Center for Cardiovascular diseases
Division name Department of Thoracic Oncology
Zip code
Address 1-3-3 Nakamichi Higashinari-ku, Osaka
TEL 06-6972-1181
Email imamura-fu@mc.pref.osaka.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazumi Nishino
Organization Osaka Medical Center for Cardiovascular diseases
Division name Department of Thoracic Oncology
Zip code
Address 1-3-3 Nakamichi Higashinari-ku, Osaka
TEL 06-6972-1181
Homepage URL
Email nisino-ka@mc.pref.osaka.jp

Sponsor
Institute Department of Thoracic Oncology
Osaka Medical Center for Cardiovascular diseases
Institute
Department

Funding Source
Organization no
Organization
Division
Category of Funding Organization Self funding
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 大阪府立成人病センター(大阪府)

Other administrative information
Date of disclosure of the study information
2014 Year 10 Month 11 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
2014 Year 10 Month 08 Day
Date of IRB
Anticipated trial start date
2014 Year 10 Month 20 Day
Last follow-up date
2016 Year 10 Month 19 Day
Date of closure to data entry
2018 Year 10 Month 19 Day
Date trial data considered complete
2018 Year 10 Month 19 Day
Date analysis concluded
2018 Year 10 Month 19 Day

Other
Other related information

Management information
Registered date
2014 Year 10 Month 11 Day
Last modified on
2018 Year 04 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017924

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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