UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008033 |
|---|---|
| Receipt number | 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 17:30:52 |
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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
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
Sponsor or person
Institute
Toho University Omori Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009460
