UMIN-CTR Clinical Trial

Basic information
Public title	First-line afatinib in patients aged 75 or older with advanced non-squamous non-small cell lung cancer harboring EGFR mutations; non-randomized phase II trial
Acronym	First-line afatinib for elderly patients
Scientific Title	First-line afatinib in patients aged 75 or older with advanced non-squamous non-small cell lung cancer harboring EGFR mutations; non-randomized phase II trial
Scientific Title:Acronym	First-line afatinib for elderly patients
Region	Japan

Condition
Condition	patients aged 75 or older with advanced non-squamous non-small cell lung cancer harboring EGFR mutations
Classification by specialty	Pneumology Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Data on efficacy and safety of afatinib for patients aged 75 years or older will be collected and evaluated.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Overall Response Rate
Key secondary outcomes	Progression Free Survival Time to Treatment Failure Overall Survival Disease Control Rate 1 and 2 Year Survival Rate Adverse Event

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	afatinib 40mg/1x
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 cytological confirmed stage III/IV non-small cell lung cancer 2. Patients having EGFR mutation (exon 19 deletion or L858R) 3. No prior chemotherapy and no prior treatment with EGFR targeting small molecules or antibodies. 4. Measurable lesion for RECIST(ver 1.1) 5. Patients aged 75 years or older 6. ECOG performance status 0 to1 7. Adequate organ function 8. Life expectancy more than three months 9. Written informed consent
Key exclusion criteria	1. Chemotherapy, biological therapy or investigational agents for other carcinomas within four weeks prior to the start of study treatment. Hormonal treatment within 2 weeks prior to start of study treatment 2. Previous radiotherapy to the primary tumor or mesurable lesion 3. Major surgery within 4 weeks before starting study treatment or scheduled for surgery during the projected course of the study 4. Patients with active lung disease such as interstitial pneumonia, active radiation pneumonitis, or drug-induced pneumonitis 5. Massive pleural or pericardial effusion, or ascites 6. Symptomatic brain metastases 7. Any history or presence of poorly controlled diseases that could affect the absorption of the study drug 8. Active infection, active hepatitis B infection, active hepatitis C infection and/or known HIV carrier. 9. Other concurrent active malignancy 10. Any history or presence of poorly controlled gastrointestinal disorders that could affect the absorption of the study drug 11. Pregnancy 12. Clinically significant phycological problem 13. Patients with uncontrollable complications 14. Known hypersensitivity to afatinib or the excipients of any of the trial drugs
Target sample size	35

Research contact person
Name of lead principal investigator	1st name Akihiko Middle name Last name Gemma
Organization	Graduate school of medicine, Nippon medical school
Division name	Department of pulmonary medicine and oncology
Zip code	113-8603
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo 113-8603, Japan
TEL	03-3822-2131
Email	agemma@nms.ac.jp

Public contact
Name of contact person	1st name Yuji Middle name Last name Minegishi
Organization	Graduate school of medicine, Nippon medical school
Division name	Department of pulmonary medicine and oncology
Zip code	113-8603
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo 113-8603, Japan
TEL	03-3822-2131
Homepage URL
Email	yminegis@nms.ac.jp

Sponsor
Institute	Non Profit Organization North East Japan Study Group
Institute
Department

Funding Source
Organization	Nippon Boehringer Ingelheim Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Nippon Medical School Hospital, Center for Clinical Research
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo 113-8603, Japan
Tel	03-3822-3131
Email	app-ccr@nms.ac.jp

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 08 Month 01 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	38
Results	Patients characteristics N=38 (SAS) Gender:Male/Female 12/23 Age:median(range) 77 (75-91) years Smoking status:Never 26(68.4%) ECOG PS:0/1 21/17 EGFR mutation type:ex19del/L858R 23/15 Promary endpoint Objective response rate:75.7% (95%CI 58.8-88.2%) Secondary endpoint Disease control rate:33% (74.6-97.0%) Adverse event: All garade 100%, grade3/4 63.2% Grade5 0%
Results date posted	2019 Year 06 Month 17 Day
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	Main results already published
Date of protocol fixation	2015 Year 05 Month 18 Day
Date of IRB	2015 Year 03 Month 27 Day
Anticipated trial start date	2015 Year 08 Month 01 Day
Last follow-up date	2019 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 06 Month 11 Day
Last modified on	2021 Year 06 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020713