UMIN-CTR Clinical Trial

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 with EGFR sensitive mutations LOGIK1302-
Acronym	LOGIK1302
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 with EGFR sensitive mutations LOGIK1302-
Scientific Title:Acronym	LOGIK1302
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 with EGFR sensitive mutations
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 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 Erlotinib 150mg/day, oral daily
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 positive 6) Age>=20years 7) ECOG PS 0-1 8) Adequate function of main organ 9) Expected survival over 3 months
Key exclusion criteria	1) EGFR mutation T790M positive 2) Active severe comorbidity disease. 3) Interstitial pneumonia or pulmonary fibrosis on chest CT scans. 4) Patients with symptomatic Brain metastases. 5) Active concomitant malignancy. 6) History of grave drug allergic reaction. 7) Pregnant or breast-feeding females. 8) Unstable psychic disorder. 9) Accepted continuous use of steroid. 10) Administration of folic acid and vitamin B12 is not received. 11) Inappropriate patients for this study judged by the physicians.
Target sample size	65

Research contact person
Name of lead principal investigator	1st name Middle name Last name Koji Inoue
Organization	Kitakyushu Municipal Medical Center
Division name	Respiratory medicine
Zip code
Address	2-1-1 Basyaku, Kokurakita-ku, Kitakyushu, JPAN, 802-0077
TEL	093-541-1831
Email	ikyoku019@c15xvmg3.securesites.net

Public contact
Name of contact person	1st name Middle name Last name Masafumi Takeshita
Organization	Kitakyushu Municipal Medical Center
Division name	Respiratory medicine
Zip code
Address	2-1-1 Basyaku, Kokurakita-ku, Kitakyushu, JPAN, 802-0077
TEL	093-541-1831
Homepage URL
Email	Ikyoku175@kmmc.jp

Sponsor
Institute	Lung Oncology Group in Kyushu, Japan (LOGIK)
Institute
Department

Funding Source
Organization	Clinical Research Support Center Kyushu
Organization
Division
Category of Funding Organization	Non profit foundation
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	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) 国立病院機構福岡東医療センター(福岡県) 産業医科大学(福岡県) 古賀病院21（福岡県） 浜の町病院（福岡県） 福岡大学(福岡県) 福岡赤十字病院(福岡県) 九州労災病院（福岡県） 原三信病院(福岡県) 福岡青州会病院(福岡県) 佐賀大学（福岡県） 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) 新別府病院（大分県） 鹿児島厚生連病院(鹿児島県) 沖縄県立南部医療センター・こども医療センター（沖縄県） 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 11 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	Completed
Date of protocol fixation	2013 Year 05 Month 18 Day
Date of IRB	2013 Year 07 Month 25 Day
Anticipated trial start date	2013 Year 07 Month 11 Day
Last follow-up date	2018 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 07 Month 11 Day
Last modified on	2021 Year 01 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013091