UMIN-CTR Clinical Trial

Basic information
Public title	Afatinib with bevacizumab as first-line therapy in patients with advanced non-squamous non-small-cell lung cancer harboring EGFR mutation:phaseI study
Acronym	Afatinib with bevacizumab as first-line therapy in patients with advanced non-squamous non-small-cell lung cancer harboring EGFR mutation:phaseI study
Scientific Title	Afatinib with bevacizumab as first-line therapy in patients with advanced non-squamous non-small-cell lung cancer harboring EGFR mutation:phaseI study
Scientific Title:Acronym	Afatinib with bevacizumab as first-line therapy in patients with advanced non-squamous non-small-cell lung cancer harboring EGFR mutation:phaseI study
Region	Japan

Condition
Condition	Non-small cell lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To investigate feasibility and recommended dose of combination therapy of afatinib with bevacizumab as first line therapy for non-small cell lung cancer patients with sensitive EGFR mutation
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	Incidence rates of dose limiting toxicity (DLT) in each therapy dose
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
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 afatinib with bevacizumab
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Histologically or cytologically proven non-squamous cell carcinoma NSCLC 2) EGFR mutation (exon19 deletion or L858R in exon 21) 3) Unresectable or impossible of radical radiotherapy 4) IIIB/IV or postoperative recurrence 5) Chemotherapy naive 6) No radiation therapy for tumor in lung 7) Measurable disease for RECIST ver.1.1 8) Age: over 20 9) PS(ECOG): 0-1 10)Adequate organ functions judged by laboratory tests 11)Life expectancy: over 3 months 12)Written informed consent
Key exclusion criteria	1) EGFR mutation (exon20) 2) Symptomatic brain metastases 3) Leptomeningeal carcinomatosis 4) Active double cancer 5) Hemoptysis or hemosputum 6) Hemophilic arthritis 7) Antiplatelet drug or anticoagulant 8) Uncontrolled high tension 9) Invasion to major arteries or vessels 10) Cavity of lung tumor 11) Therapy needed effusion (pleural or pericardial or ascites) 12) SVC syndrome 13) Interstitial pneumonitis or pneumonia 14) Gastrointestinal disturbance 15) Severe allergic history 16) Pregnancy 17) Inadequate patients whom physitians considered
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Middle name Last name Katsuyuki Kiura
Organization	Okayama University Hospital
Division name	Department of Respiratory Medicine
Zip code
Address	2-5-1, Shikatacho, Okayama, Japan
TEL	086-223-7151
Email	tninomiya5@gmail.com

Public contact
Name of contact person	1st name Middle name Last name Takashi Ninomiya
Organization	Okayama University Hospital
Division name	Department of Respiratory Medecine
Zip code
Address	2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, Japan
TEL	086-235-7227
Homepage URL
Email	tninomiya5@gmail.com

Sponsor
Institute	Okayama Lung Cancer Study Group (OLCSG)
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	2014 Year 12 Month 16 Day

Related information
URL releasing protocol
Publication of results	Partially published

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	Completed
Date of protocol fixation	2014 Year 12 Month 16 Day
Date of IRB	2014 Year 12 Month 16 Day
Anticipated trial start date	2014 Year 12 Month 17 Day
Last follow-up date	2018 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2018 Year 10 Month 01 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 12 Month 14 Day
Last modified on	2019 Year 06 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018477