UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of erlotinib in elderly patients with non-small-cell lung cancer harboring epidermal growth factor receptor mutations: A phase 2 study.
Title of the study (Brief title)	Efficacy and safety of erlotinib in elderly patients with EGFR-mutations-positive NSCLC.
Region	Japan

Condition
Condition	non-small-cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is to assess the efficacy and safety of erlotinib in elderly patients aged 75 years or older with non-small-cell lung cancer harboring epidermal growth factor receptor mutations.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Response rate
Key secondary outcomes	Progression free survival, overall survival, safety, QOL score

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	Elderly patients with EGFR-mutations-positive non-small-cell lung cancer receive elrotinib.
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	75 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	All participants must meet the following criteria. 1: Histologically or pathologically proven NSCLC; stage 3B, 4, or reccurence. 2: EGFR mutation positive. 3: Aged 75 years or older. 4: Eastern Cooperative Oncology Group (ECOG) performance status of 0-3. 4: Stage 3B/4 NSCLC. 5: Chemotherapy naive or received 1 regimen chemotherapy. 6: Never administerd EGFR-TKI. 7: a. Hemoglobin: more than 9.0 g/dL. b. Neutrophil count: more than 3,000/uL. c. Platelet count: more than 100,000/uL. d. Aspartate transaminase (AST), alanine transaminase(ALT): less than 2.5 times the upper limit of normal of the institutional reference range. e. Total bilirubin: less than 1.5 times the upper limit of normal of the institutional reference range. 8: Life expectancy of more than 3 months. 9: Written informed consent.
Key exclusion criteria	Exclusion criteria are as follows 1: History of severe allergic reactions to drugs. 2: Pregnancy or lactation. 3: Willing to get pregnant. 4: Interstitial lung disease. 5: Severe infection. 6; Severe and unstable medical comorbidities. 7: Difficulty in ingestion. 8: Uncontrolled brain metastases. 9: EGFR T790M mutation. 10: Judgment to attending physician.
Target sample size	30

Research contact person
Name of lead principal investigator	Takafumi Suda
Organization	Hamamatsu University School of Medicine
Division name	Second Division, Department of Internal Medicine
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu-city, Japan
TEL	053-435-2263
Email	suda@hama-med.ac.jp

Public contact
Name of contact person	Yusuke Inoue
Organization	Hamamatsu University School of Medicine
Division name	Second Division, Department of Internal Medicine
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu-city, Japan
TEL	053-435-2111
Homepage URL
Email	y.inoue@hama-med.ac.jp

Sponsor
Institute	Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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	2013 Year 04 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 04 Month 01 Day
Anticipated trial start date	2013 Year 04 Month 17 Day
Last follow-up date	2015 Year 04 Month 08 Day
Date of closure to data entry
Date trial data considered complete	2015 Year 04 Month 08 Day
Date analysis concluded	2015 Year 04 Month 08 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 04 Month 17 Day
Last modified on	2016 Year 06 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012306