UMIN-CTR Clinical Trial

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
Email	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
Email	akinoue@idac.tohoku.ac.jp

Sponsor
Institute	North-East Japan Study Group
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007519