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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002716
Receipt No. R000003311
Scientific Title A Phase II Study of Erlotinib for previously treated Non-small cell Lung Cancer Patients with Epidermal Growth Factor Receptor Mutation
Date of disclosure of the study information 2009/11/06
Last modified on 2014/11/05

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Basic information
Public title A Phase II Study of Erlotinib for previously treated Non-small cell Lung Cancer Patients with Epidermal Growth Factor Receptor Mutation
Acronym A Phase II Study of Erlotinib for previously treated Non-small cell Lung Cancer with EGFR Mutation
Scientific Title A Phase II Study of Erlotinib for previously treated Non-small cell Lung Cancer Patients with Epidermal Growth Factor Receptor Mutation
Scientific Title:Acronym A Phase II Study of Erlotinib for previously treated Non-small cell Lung Cancer with EGFR Mutation
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To investigate efficacy and safety of Erlotinib for previously treated Non-small cell Lung Cancer Patients with Epidermal Growth Factor Receptor Mutation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes rseponse rate
Key secondary outcomes Disease control rate, Progression free survival, overall survival, Median survival time, 1-year survival rate, Evaluation of safety

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 Erlotinib treatment
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 pathologically proven non-small cell lung cancer.
2) Patients with stage IIIB or IV who are not candidates for curative radiotherapy.
3) Patients having EGFR mutation (exon 19 deletion or L858R) by PNA-LNA PCR clamp method.
4) No prior treatment with medicine concerning HER(gefitinib, trastuzumab, lapatinib, cetuximab,etc.).
5) Patients who have previously treated one or two chemotherapy(prior chemotherapy consisting of platinum agents in at least one regimen).
6) Patient who has at least one or more measurable lesion by RECIST.
7) ECOG performance status (PS): 0-2
8) Patients who can be hospitalized for four weeks after beginning of the treatment or under management to apply to it.
9) Patients aged 20 years or older.
10) Adequate organ function.
11) Patients who are considered to survive for more than 3 months.
12) Written informed consent.
Key exclusion criteria 1) Active infection or other serious disease condition (poorly controlled diabetes mellitus,cardiac disease, Unstable angina, Cardiac infarction, Psychological illness, etc.).
2) Pulmonary disorder(idiopathic pulmonary fibrosis,interstitial lung disease, pneumoconiosis, active radiation pneumonia, etc.).
3) Massive pleural effusion, pericardial effusion, ascites, and superior vena cava syndrome.
4) Symptomatic brain metastasis.
5) Severe drug allergy.
6) Previous radiotherapy to primary lung cancer.
7) Patients who have previously treated three or more chemotherapy.
8) Patients who had a relapse after surgery.
9) With active double cancer.
10) Pregnancy or lactation.
11) Severe disorder of the eye.
12) Patients whose participation in the trial is judged to be inappropriate by the attending doctor.
Target sample size 29

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshinori Hasegawa
Organization Nagoya University Graduate School of Medicine
Division name Department of Respiratory Medicine
Zip code
Address 65 Tsurumai-cho, Showo-ku, Nagoya-City, Aichi, 466-8550, Japan
TEL 052-744-2167
Email yhasega@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masashi Kondo, Masahiro Morise, Tetsunari Hase
Organization Nagoya University Graduate School of Medicine
Division name Department of Respiratory Medicine
Zip code
Address 65 Tsurumai-cho, Showo-ku, Nagoya-City, Aichi, 466-8550, Japan
TEL 052-744-2167
Homepage URL http://cjlsg.umin.jp/index.html
Email cjlsg@med.nagoya-u.ac.jp

Sponsor
Institute Central Japan Lung Study Group (CJLSG)
Institute
Department

Funding Source
Organization None
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

Other administrative information
Date of disclosure of the study information
2009 Year 11 Month 06 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 No longer recruiting
Date of protocol fixation
2009 Year 09 Month 20 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2012 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 11 Month 05 Day
Last modified on
2014 Year 11 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003311

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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