UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006340 |
|---|---|
| Receipt number | R000007519 |
| Scientific Title | Phase III study comparing gefitinib with gefitinib combined with carboplatin/pemetrexed for advanced non-small cell lung cancer with EGFR mutation (NEJ009) |
| Date of disclosure of the study information | 2011/10/01 |
| Last modified on | 2019/09/19 09:21:20 |
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Basic information
Public title
Phase III study comparing gefitinib with gefitinib combined with carboplatin/pemetrexed for advanced non-small cell lung cancer with EGFR mutation (NEJ009)
Acronym
Gefitinib vs Gefitinib plus chemotherapy for EGFR-mutated NSCLC (NEJ009)
Scientific Title
Phase III study comparing gefitinib with gefitinib combined with carboplatin/pemetrexed for advanced non-small cell lung cancer with EGFR mutation (NEJ009)
Scientific Title:Acronym
Gefitinib vs Gefitinib plus chemotherapy for EGFR-mutated NSCLC (NEJ009)
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the superiority of gefitinib/carboplatin/pemetrexed against gefitinib alone in progression-free survival(PFS), PFS in experimental arm versus second PFS in gefitinib alone arm, and overall survival by gate-keeping method.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression-free survival, second PFS in gefitinib alone arm, and Overall survival
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Gefitinib alone until disease progression, unacceptable toxicity, or patient's refusal
Interventions/Control_2
Gefitinib/carboplatin/pemetrexed until disease progression, unacceptable toxicity, or patient's refusal
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Histologically confirmed non-squamous cell lung cancer harboring sensitive EGFR mutation
2. Chemotherapy naive
3. Having adequate organ functions and good performance status (ECOG PS 0-1)
4. With written informed consent
Key exclusion criteria
1. NSCLC harboring T790M mutation
2. With massive effusion that require drainage
3. With symptomatic brain metastasis
4. With severe co-morbidities
5. With ineligible conditions judged by the attending physician
Target sample size
340
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Inoue |
Organization
Tohoku University Hospital
Division name
Department of Respiratory Medicine
Zip code
9808574
Address
1-1, Seiryomachi, Aobaku, Sendai
TEL
+81-22-717-8539
akinoue@idac.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Inoue |
Organization
Tohoku University Hospital
Division name
Department of Respiratory Medicine
Zip code
9807574
Address
1-1, Seiryocho, Aobaku, Sendai
TEL
022-717-8539
Homepage URL
akinoue@idac.tohoku.ac.jp
Sponsor or person
Institute
North-East Japan Study Group
Institute
Department
Personal name
Funding Source
Organization
MHLW (Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University Hospital IRB
Address
1-1, Seiryomachi, Aobaku Sendai
Tel
022-717-7366
akinoue@idac.tohoku.ac.jp
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
| 2011 | Year | 10 | 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
345
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
Completed
Date of protocol fixation
| 2011 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2011 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2011 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 13 | Day |
Last modified on
| 2019 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007519
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
