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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008033
Receipt No. R000009460
Scientific Title A phase II study of Erlotinib plus Pemetrexed for Non Small Cell Lung Cancer with T790M negative previously treated with EGFR-TKI
Date of disclosure of the study information 2012/06/01
Last modified on 2012/05/26

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Basic information
Public title A phase II study of Erlotinib plus Pemetrexed for Non Small Cell Lung Cancer with T790M negative previously treated with EGFR-TKI
Acronym A phase II study of Erlotinib plus Pemetrexed for Non Small Cell Lung Cancer with T790M negative previously treated with EGFR-TKI
Scientific Title A phase II study of Erlotinib plus Pemetrexed for Non Small Cell Lung Cancer with T790M negative previously treated with EGFR-TKI
Scientific Title:Acronym A phase II study of Erlotinib plus Pemetrexed for Non Small Cell Lung Cancer with T790M negative previously treated with EGFR-TKI
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Medicine in general Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy and safety of Erlotinib plus Pemetrexed for non-small cell lung cancer with T790M negative previously treated with EGFR-TKI
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Disease control rate
Key secondary outcomes Response rate
Overall survival
Progression free survival
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 A combined chemotherapy of Erlotinib plus Pemetrexed
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 or cytologically confirmed non-small cell lung cancer
2) Stage IIIB/IV or postoperative recurrence NSCLC
3) Patients with EGFR mutation (exon 18 or 19 or 21)
4) Patients aged 20 years or older.
5) Previously treated EGFR-TKI
6) Previously treated no or one chemotherapy regimen after EGFR-TKI
7) Patients who do not possess T790M
8) ECOG performance status of 0-2
9) Measureable region evaluable according to the RECIST(ver.1.1)
10) Expected to be observed for at least 2 to 4 weeks in a hospital or in a comparable institution after the initiation of this treatment
11) Adequate organ function.
12) More than 4 weeks after the last chemotherapy
13) Patients who are considered to survive for more than 3 months
14) Written informed consent from the patient
Key exclusion criteria 1) Presence of active interstitial pneumonia, radiation pneumonia, pneumoconiosis, or drug induced pneumonia
2) Uncontrolled pleural effusion, ascites, or pericardial effusion
3) Previously treated with Pemetrexed
4) Patients with active severe infections
5) Impossible cases with oral administration
6) Patients with uncontrollable complications
7) Pregnancy, breast feeding and suspected pregnancy
8) Active concomitant malignancy
9) Inappropriate patients for this study judged by the physicians
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazutoshi Isobe
Organization Toho University Omori Medical Center
Division name Department of Respiratory Medicine
Zip code
Address 6-11-1, Omori-Nishi, Ota-ku, Tokyo, Japan
TEL 03-3762-4151
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazutoshi Isobe
Organization Toho University Omori Medical Center
Division name Department of Respiratory Medicine
Zip code
Address
TEL 03-3762-4151
Homepage URL
Email

Sponsor
Institute Toho University Omori Medical Center
Institute
Department

Funding Source
Organization Non
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 東邦大学医療センター大森病院(東京都)

Other administrative information
Date of disclosure of the study information
2012 Year 06 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
2012 Year 05 Month 26 Day
Date of IRB
Anticipated trial start date
2012 Year 06 Month 01 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
2012 Year 05 Month 26 Day
Last modified on
2012 Year 05 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009460

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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