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 |
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
LOGIK1301
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
LOGIK1301
Japan |
Non-Small Cell Lung Cancer
Pneumology | Hematology and clinical oncology |
Malignancy
NO
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
Safety,Efficacy
Exploratory
Phase II
Progression Free Survival
Overall Survival
Safety
Biomarker analysis
Objective Response Rate
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
2
Treatment
Medicine |
Pemetrexed 500mg/sqm+CBDCA AUC 6: intravenous q3w 4cycles
Pemetrexed 500mg/sqm:intravenous q3w
Pemetrexed 500mg/sqm+CBDCA AUC 6: intravenous q3w 4cycles
Erlotinib 150mg/day, oral daily
20 | years-old | <= |
Not applicable |
Male and Female
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
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.
120
1st name | Koji |
Middle name | |
Last name | Inoue |
Kitakyushu Municipal Medical Center
Respiratory medicine
802-0077
2-1-1 Basyaku, Kokurakita-ku,Kitakyushu, JPAN, 802-0077
093-541-1831
ikyoku019@c15xvmg3.securesites.net
1st name | Masafumi |
Middle name | |
Last name | Takeshita |
Kitakyushu Municipal Medical Center
Respiratory medicine
802-0077
2-1-1 Basyaku, Kokurakita-ku,Kitakyushu, JPAN, 802-0077
093-541-1831
Ikyoku175@kmmc.jp
Lung Oncology Group in Kyushu, Japan (LOGIK)
Clinical Research Support Center Kyushu
Non profit foundation
JAPAN
Kitakyushu Municipal Medical Center IRB
2-1-1 Basyaku, Kokurakita-ku,Kitakyushu, JPAN, 802-0077
093-541-1831
Ikyoku175@kmmc.jp
NO
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)
2013 | Year | 07 | Month | 05 | Day |
Unpublished
Terminated
2013 | Year | 05 | Month | 23 | Day |
2013 | Year | 07 | Month | 25 | Day |
2013 | Year | 07 | Month | 25 | Day |
2018 | Year | 06 | Month | 01 | Day |
The study was terminated due to failure to reach the number of cases.
2013 | Year | 07 | Month | 05 | Day |
2023 | Year | 01 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013024