UMIN-CTR Clinical Trial

Basic information
Public title	A phase II study of erlotinib plus bevacizumab in chemo-naive patients aged 75 or older with advanced non-squamous non-small-cell lung cancer harboring sensitive EGFR gene mutations(HSR1501)
Acronym	A phase II study of AT for advanced Non-Sq NSCLC in elderly patients(HSR1501)
Scientific Title	A phase II study of erlotinib plus bevacizumab in chemo-naive patients aged 75 or older with advanced non-squamous non-small-cell lung cancer harboring sensitive EGFR gene mutations(HSR1501)
Scientific Title:Acronym	A phase II study of AT for advanced Non-Sq NSCLC in elderly patients(HSR1501)
Region	Japan

Condition
Condition	Advanced non-squamous 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 evaluate the efficacy and safety of erlotinib plus bevacizumab in chemo-naive patients aged 75 or older with advanced non-squamous non-small-cell lung cancer harboring sensitive EGFR gene mutations.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

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

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 erlotinib plus bevacizumab every three weeks, as long as patients do not apply to treatment discontinuation criteria, until the disease progresses.
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	All participants must meet the following criteria 1: Pathologically proven Non-Sq NSCLC 2: Radiographically measurable lesion 3: Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 4: Stage 3B/4 NSCLC or recurrence disease without prior chemotherapy 5: Age more than 75 years 6: adequate organ function Neutrophil count: more than 1,500/uL Platelet count: more than 100,000/uL Hemoglobin: more than 9.0 g/dL Aspartate transaminase (AST), alanine transaminase(ALT): 2.5 times the upper limit of normal of the institutional reference range Total bilirubin: less than 1.5mg/dL. PaO2: more than 60 torr Serum creatinine: less than 1.5mg/dL 7: Life expectancy of more than 12 weeks 8: Written informed consent 9:Sensitive EGFR mutation (exon19 deletion or exon21 L858R) confirmed by PCR
Key exclusion criteria	Exclusion criteria are as follows 1: Squamous cell carcinoma 2: Active interstitial pneumonia identified by chest X-ray 3: Current or previous histoty of hemoptysis (2.5ml) due to NSCLC 4: Uncontrolled massive pleural effusion or cardiac effusion 5: Superior vena cava syndrome 6: Uncontrolled brain metastases 7: Uncontrolled diabetes mellitus, hypertension, hepatic disorder, angina pectoris or previous myocardial infarction within the last 3 months 8: Severe infection 9: Pregnancy or lactation 10: Active concomitant malignancy 11: History of severe allergic reactions to drugs 12: Evidence of bleeding diathesis or hemoptysis 13: Current or previous history of cerebrovascular disease 14: Current or previous history of GI perforation 15: A history of chest irradaiation. 16: Exon T790M mutation detected by PCR 17: Severe and unstable medical comorbidities 18: Being unsuitable for receiving the study treatment, judged by attending physicians
Target sample size	26

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takafumi Suda
Organization	Hamamatsu Univ. School of Medicine
Division name	Department of Internal medicine, second division
Zip code
Address	Handayama 1-20-1, Hamamatsu, Shizuoka pref. Japan
TEL	053-435-2263
Email	suda@hama-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Seiichiro Suzuki
Organization	Hamamatsu Univ. School of Medicine
Division name	Department of Internal medicine, second division
Zip code
Address	Handayama 1-20-1, Hamamatsu, Shizuoka pref. Japan
TEL	053-435-2111
Homepage URL
Email	sesuzuki@hama-med.ac.jp

Sponsor
Institute	Department of Internal medicine, second division, Hamamatsu Univ. School of Medicine
Institute
Department

Funding Source
Organization	Department of Internal medicine, second division, Hamamatsu Univ. School of Medicine
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 03 Month 24 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	Open public recruiting
Date of protocol fixation	2015 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date	2015 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 03 Month 24 Day
Last modified on	2016 Year 09 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019620

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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