UMIN-CTR Clinical Trial

Basic information
Public title	Phase 2 study of Pemetrexed + Carboplatin as first line therapy for non-squamous non-small cell lung cancer with EGFR Mutation (CJLSG0907)
Acronym	Pemetrexed + Carboplatin as first line therapy for non-squamous non-small cell lung cancer with EGFR Mutation
Scientific Title	Phase 2 study of Pemetrexed + Carboplatin as first line therapy for non-squamous non-small cell lung cancer with EGFR Mutation (CJLSG0907)
Scientific Title:Acronym	Pemetrexed + Carboplatin as first line therapy for non-squamous non-small cell lung cancer with EGFR Mutation
Region	Japan

Condition
Condition	Advanced non-squamous non-small cell lung cancer with EGFR Mutation
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To evaluate the efficacy and safety of combination therapy with pemetrexed and carboplatin for non-squamous non small cell lung cancer patients with epidermal growth factor receptor mutation.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Response rate
Key secondary outcomes	Adverse events Disease control rate Overall survival Progression free survival

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Pemetrexed 500mg/m2 day1 + Carboplatin AUC6 day1, q3w, 3-6 cycles
Interventions/Control_2
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 non-squamous non small cell lung cancer 2) Patients having EGFR mutation (exon 19 deletion or L858R) 3) Patients with stage IIIB or IV, or recurrent disease after surgery and was not a candidate for curative radiotherapy 4) No prior chemotherapy 5) Patient who has measurable lesion by RECIST 6) Age: 20-74 7) ECOG PS: 0-1 8) Adequate organ function 9) Life expectancy more than 3 months 10) Written informed consent
Key exclusion criteria	1) Active infection 2) Fever 3) Serious disease condition 4) Active double cancer 5) Symptomatic brain metastasis 6) Cavity fluid retention difficult to control 7) Severe drug allergy 8) Pregnancy or lactation 9) EGFR mutation (exon 20) 10) Patients whose participation in the trial is judged to be inappropriate by the attending doctor
Target sample size	23

Research contact person
Last name of lead principal investigator	1st name Hiroyuki Middle name Last name Taniguchi
Organization	Tosei General Hospital
Division name	Respiratory medicine and allergy
Zip code	4898642
Address	160 Nishi-oiwake-cho, Seto, Aichi, Japan
TEL	0561-82-5101
Email	taniguchi@tosei.or.jp

Public contact
1st name of contact person	1st name Tomoki Middle name Last name Kimura
Organization	Tosei General Hospital
Division name	Respiratory medicine and allergy
Zip code	4898642
Address	160 Nishi-oiwake-cho, Seto, Aichi, Japan
TEL	0561-82-5101
Homepage URL
Email	lung@tosei.or.jp

Sponsor
Institute	Central Japan Lung Study 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	Tosei General Hospital IRB
Address	160 Nishi-oiwakecho, Seto, Aichi
Tel	0561-82-5101
Email	ychikenn@tosei.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	2010 Year 03 Month 29 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	Main results already published
Date of protocol fixation	2010 Year 01 Month 30 Day
Date of IRB	2010 Year 02 Month 01 Day
Anticipated trial start date	2010 Year 02 Month 01 Day
Last follow-up date	2016 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2010 Year 03 Month 28 Day
Last modified on	2019 Year 03 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004080