UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of gefitinib combined with carboplatin/pemetrexed for elderly patients with EGFR mutated advanced non-small cell lung cancer
Acronym	Gefitinib plus chemotherapy for elderly patient with EGFR-mutated NSCLC
Scientific Title	Phase II study of gefitinib combined with carboplatin/pemetrexed for elderly patients with EGFR mutated advanced non-small cell lung cancer
Scientific Title:Acronym	Gefitinib plus chemotherapy for elderly patient with EGFR-mutated NSCLC
Region	Japan

Condition
Condition	Non-small cell lung cancer
Classification by specialty	Pneumology Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety for elderly patients treated with gefitinib plus carboplatin/pemetrexed.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Progression Free Survival (PFS)
Key secondary outcomes	Objective Response Rate, Disease Control Rate, Adverse Events, Overall Survival, QOL

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	Patients receive oral gefitinib 250mg once daily and carboplatin(AUC=5)/ pemetrexed(500mg/m2) on day1 every 3 weeks.
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	75 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Histologically or cytologically confirmed non-small cell lung cancer. 2) Clinical Stage IIIB which curative radiotherapy is not indicated, IV or postoperative recurrence 3) EGFR mutation positive 4) At least one measurable lesion 5) No prior chemotherapy treatment 6) Age of 75 years or older 7) ECOG Performance status of 0-1 8) Sufficient major organ function 9) Life expectancy of at least 3 months 10) Written informed consent
Key exclusion criteria	1) Radiographically confirmed interstitial pneumonitis or pulmonary fibrosis. 2) NSCLC harboring T790M mutation 3) No prior gefitinib or pemetrexed treatment as ajuvant/neoajuvant therapy. 4) Symptomatic brain metastases 5) Radiation therapy for primary site. 6) Severe concurrent disease 7) HBs antigen or HBc antibody or HBs antibody positive 8) Patient are treated with steroid continuously 9) Pleural and peritoneal effusion likely to require surgical intervention, or pericardial effusion 10) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy. 11) Active double cancer 12) Physician concludes that the patient's participation in this trial is inappropriate.
Target sample size	35

Research contact person
Name of lead principal investigator	1st name Middle name Last name Akira Inoue
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Palliative Medicine
Zip code
Address	1-2, Seiryocho, Aobaku, Sendai
TEL	+81-22-717-7366
Email	akira.inoue.b2@tohoku.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Eisaku Miyauchi
Organization	Tohoku University Hospital
Division name	Department of Respiratory Medicine
Zip code
Address	1-1, Seiryocho, Aobaku, Sendai
TEL	+81-22-717-8539
Homepage URL
Email	miyauchi@rm.med.tohoku.ac.jp

Sponsor
Institute	Tohoku University Hospital
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
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

Other administrative information
Date of disclosure of the study information	2015 Year 01 Month 30 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	Terminated
Date of protocol fixation	2014 Year 11 Month 01 Day
Date of IRB	2015 Year 01 Month 31 Day
Anticipated trial start date	2015 Year 02 Month 25 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2019 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date	2015 Year 01 Month 30 Day
Last modified on	2019 Year 08 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019038