UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011126 |
|---|---|
| Receipt number | R000013024 |
| Scientific Title | A randomized Phase II study of Carboplatin + Pemetrexed followed by Pemetrexed versus Carboplatin+Pemetrexed followed by Erlotinib in patients with advanced Non-squamous and Non- Small Cell Lung Cancer without EGFR mutations |
| Date of disclosure of the study information | 2013/07/05 |
| Last modified on | 2023/01/11 09:14:18 |
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Basic information
Public title
A randomized Phase II study of Carboplatin + Pemetrexed followed by Pemetrexed versus Carboplatin+Pemetrexed followed by Erlotinib in patients with advanced Non-squamous and Non- Small Cell Lung Cancer without EGFR mutations
Acronym
LOGIK1301
Scientific Title
A randomized Phase II study of Carboplatin + Pemetrexed followed by Pemetrexed versus Carboplatin+Pemetrexed followed by Erlotinib in patients with advanced Non-squamous and Non- Small Cell Lung Cancer without EGFR mutations
Scientific Title:Acronym
LOGIK1301
Region
| Japan |
Condition
Condition
Non-Small Cell Lung Cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the efficacy and safety of carboplatin + pemetrexed followed by pemetrexed and carboplatin+pemetrexed followed by erlotinib in patients with advanced non-squamous and non- small cell lung cancer without EGFR mutations. Another purpose is to explore the biomarkers predicting the treatment efficacy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Progression Free Survival
Key secondary outcomes
Overall Survival
Safety
Biomarker analysis
Objective Response Rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Pemetrexed 500mg/sqm+CBDCA AUC 6: intravenous q3w 4cycles
Pemetrexed 500mg/sqm:intravenous q3w
Interventions/Control_2
Pemetrexed 500mg/sqm+CBDCA AUC 6: intravenous q3w 4cycles
Erlotinib 150mg/day, oral daily
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) Provided written informed consent
2) Histologically or cytologically confirmed non-squamous NSCLC,prior chemotherapy (containing EGFR-TKIs) is not accepted
3) Measurable lesions (RECIST)
4) StageIIIB/IV or postoperative recurrence NSCLC
5) EGFR mutation negative
6) Age>=20years
7) ECOG PS 0-1
8) Adequate function of main organ
9) Expected survival over 3 months
Key exclusion criteria
1) Active severe comorbidity disease.
2) Interstitial pneumonia or pulmonary fibrosis on chest CT scans.
3) Patients with symptomatic Brain metastases.
4) Active concomitant malignancy.
5) History of grave drug allergic reaction.
6) Pregnant or breast-feeding females.
7) Unstable psychic disorder.
8) Accepted continuous use of steroid.
9) Administration of folic acid and vitamin B12 is not received.
10) Diagnosed EML4-ALK fusion gene positive.
11) Inappropriate patients for this study judged by the physicians.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Inoue |
Organization
Kitakyushu Municipal Medical Center
Division name
Respiratory medicine
Zip code
802-0077
Address
2-1-1 Basyaku, Kokurakita-ku,Kitakyushu, JPAN, 802-0077
TEL
093-541-1831
ikyoku019@c15xvmg3.securesites.net
Public contact
Name of contact person
| 1st name | Masafumi |
| Middle name | |
| Last name | Takeshita |
Organization
Kitakyushu Municipal Medical Center
Division name
Respiratory medicine
Zip code
802-0077
Address
2-1-1 Basyaku, Kokurakita-ku,Kitakyushu, JPAN, 802-0077
TEL
093-541-1831
Homepage URL
Ikyoku175@kmmc.jp
Sponsor or person
Institute
Lung Oncology Group in Kyushu, Japan (LOGIK)
Institute
Department
Personal name
Funding Source
Organization
Clinical Research Support Center Kyushu
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitakyushu Municipal Medical Center IRB
Address
2-1-1 Basyaku, Kokurakita-ku,Kitakyushu, JPAN, 802-0077
Tel
093-541-1831
Ikyoku175@kmmc.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
北九州市立医療センター(福岡県)
九州大学(福岡県)
飯塚病院(福岡県)
国立病院機構大牟田病院(福岡県)
国立病院機構九州医療センター(福岡県)
産業医科大学(福岡県)
福岡大学(福岡県)
福岡赤十字病院(福岡県)
原三信病院(福岡県)
福岡青州会病院(福岡県)
佐賀県立病院好生館(佐賀県)
健康保険諫早総合病院(長崎県)
日本赤十字社 長崎原爆病院(長崎県)
熊本地域医療センター(熊本県)
国立病院機構熊本医療センター(熊本県)
大分大学(大分県)
新別府病院（大分県）
国立病院機構 宮崎東病院(宮崎県)
宮崎県立宮崎病院(宮崎県)
鹿児島厚生連病院(鹿児島県)
国立病院機構沖縄病院（沖縄県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 05 | 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
| 2013 | Year | 05 | Month | 23 | Day |
Date of IRB
| 2013 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2013 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study was terminated due to failure to reach the number of cases.
Management information
Registered date
| 2013 | Year | 07 | Month | 05 | Day |
Last modified on
| 2023 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013024
| Research Plan | |
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| 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 |
