UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The combination therapy of pemetrexed and continued EGFR-TKIs beyond disease progression to first-line EGFR-TKIs treatments in elderly patients with advanced non-small-cell lung cancer harboring EGFR mutations: a phase 2 trial.
Title of the study (Brief title)	Pemetrexed and continued EGFR-TKIs beyond progressive disease in elderly patients with EGFR-mutant advanced NSCLC.
Region	Japan

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

Objectives
Narrative objectives1	To assess the efficacy and safety of combination therapy of pemetrexed and continued EGFR-TKIs beyond disease progression to first-line EGFR-TKIs treatments in elderly patients with EGFR-mutant advanced NSCLC.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Disease control rate
Key secondary outcomes	Progression free survival, overall survival, adverse events

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	The combination therapy of pemetrexed and continued EGFR-TKIs in elderly patients with EGFR-mutant advanced NSCLC that has developed acquired resistance to EGFR-TKIs is assessed.
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 non-squamous NSCLC. 2: Stage 3B, 4, or recurrence. 3: EGFR mutation positive. 4: Previously treated with EGFR-TKIs more than 8 weeks effectively (SD,PR, or CR), then acquired resistance. 5: Radiographically measurable lesion. 6: Age 75 years or older. 7: Eastern Cooperative Oncology Group (ECOG) performance status: 0-2. 8: No major organ system dysfunction. a. White blood cell count: more than 3,000/uL. b. Neutrophil cell count: more than 1500/uL. c. Hemoglobin: more than 9.0 g/dL. d. Platelet count: more than 100,000/uL. e. Aspartate transaminase (AST), alanine transaminase(ALT): less than 2.5 times the upper limit of normal of the institutional reference range. f. Total bilirubin: less than 1.5 times the upper limit of normal of the institutional reference range. g. Creatinine: less than 1.2 mg/dL. h. Creatinine clearance: more than 45 ml/min. i. SpO2: more than 90%. 9: No interstitial lung disease. 10: Life expectancy of more than 3 months. 11: Written informed.
Key exclusion criteria	Exclusion criteria are as follows 1: Symptomatic brain metastasis. 2: History of radiotherapy to primary lesion. 3: Severe and unstable medical comorbidities. 4: Difficulty in ingestion. 5: With third-space fluid to be drained. 6: Pregnant or breastfeeding women. Willing to get pregnant. 7: Contraindication for taking EGFR-TKIs. 8: Active double cancers. 9: History of severe allergy to drugs. 10: Judgment to attending physician.
Target sample size	22

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	053-435-2111
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 06 Month 12 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 04 Month 30 Day
Anticipated trial start date	2013 Year 06 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2013 Year 06 Month 12 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=R000012800