UMIN-CTR Clinical Trial

Basic information
Public title	Randomized phase II study of continuous gefitinib plus chemotherapy versus alternation of gefitinib and chemotherapy in previously untreated non-small cell lung cancer (NSCLC) with sensitive EGFR mutations (NEJ005/TCOG0902)
Acronym	Continuous gefitinib plus chemotherapy versus alternation of gefitinib and chemotherapy in NSCLC with EGFR mutations
Scientific Title	Randomized phase II study of continuous gefitinib plus chemotherapy versus alternation of gefitinib and chemotherapy in previously untreated non-small cell lung cancer (NSCLC) with sensitive EGFR mutations (NEJ005/TCOG0902)
Scientific Title:Acronym	Continuous gefitinib plus chemotherapy versus alternation of gefitinib and chemotherapy in NSCLC with EGFR mutations
Region	Japan

Condition
Condition	Non-small cell lung cancer with EGFR mutations (non-squamous histology)
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate efficacy and safety in combination of chemotherapy and gefitinib therapy in non-small cell lung cancer (NSCLC) harboring sensitive EGFR mutations by comparing continuous gefitinib plus chemotherapy with alternation of gefitinib and chemotherapy
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	Response rate, overall survival, and safety

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
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Continuous gefitinib plus chemotherapy (Carboplatin + Pemetrexed)
Interventions/Control_2	Alternation of gefitinib and chemotherapy (Carboplatin + Pemetrexed)
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 or cytologically proven NSCLC (non-squamous histology) 2) Stage IIIB, IV, or relapsed NSCLC 3) NSCLC harboring sensitive EGFR mutations 4) At least one measurable lesion 5) Chemotherapy-naive patients 6) Over 20 years old and under 75 years old 7) ECOG performance status of 0-1 8) Adequate organ functions (WBC >= 4,000 /mm3, Neutrophil >= 2,000 /mm3, Platelet >= 100,000 /mm3, Hemoglobin concentration >= 9.0 g/dl, AST or ALT <= twice the number of ULN, T-bilirubin <= 1.5 mg/dl, Cr <= 1.5 mg/dl, PaO2 or SpO2 >= 60 Torr or 95%) 9) Life expectancy of at least 3 months 10) Written informed consent
Key exclusion criteria	1) Presence of active interstitial pneumonia 2) Resistant T790M mutation 3) Unstable metastases to the brain 4) History of radiotherapy for primary lesion 5) Severe and uncontrolled complication 6) Severe gastroenterological and intestinal disease 7) Treatment with steroid for longer than 4 weeks 8) Uncontrolled pleural effusion or ascites 9) Pregnant patients 10) Gefitinib contraindication 11) Other active malignancies 12) Decision of ineligibility by a physician
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Satoshi Middle name Last name Oizumi
Organization	National Hospital Organization Hokkaido Cancer Center
Division name	Department of Respiratory Medicine
Zip code	003-0804
Address	3-54 Kikusui 4-2 Shiroishi-ku, Sapporo 003-0804, Japan
TEL	011-811-9111
Email	soizumi@hokkaido.med.or.jp

Public contact
Name of contact person	1st name Satoshi Middle name Last name Oizumi
Organization	National Hospital Organization Hokkaido Cancer Center
Division name	Department of Respiratory Medicine
Zip code	003-0804
Address	3-54 Kikusui 4-2 Shiroishi-ku, Sapporo 003-0804, Japan
TEL	011-811-9111
Homepage URL
Email	soizumi@hokkaido.med.or.jp

Sponsor
Institute	North East Japan Study Group/The Tokyo Cooperative Oncology Group
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The ethics review boards, Hokkaido Cancer Center
Address	3-54 Kikusui 4-2 Shiroishi-ku, Sapporo 003-0804, Japan
Tel	011-811-9111
Email	soizumi@hokkaido.med.or.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	2009 Year 11 Month 20 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications	http://www.ncbi.nlm.nih.gov/pubmed/25669832
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	Main results already published
Date of protocol fixation	2009 Year 11 Month 04 Day
Date of IRB	2009 Year 11 Month 04 Day
Anticipated trial start date	2009 Year 12 Month 01 Day
Last follow-up date	2017 Year 04 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	2009 Year 11 Month 20 Day
Last modified on	2021 Year 08 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000003380