UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of EGFR-TKI rechallenge with afatinib in advanced NSCLC patients haboring sensitive EGFR mutation without T790M
Title of the study (Brief title)	Phase II study of EGFR-TKI rechallenge with afatinib in advanced NSCLC patients haboring sensitive EGFR mutation without T790M
Region	Japan

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

Objectives
Narrative objectives1	To investigate the efficacy of EGFR-TKI rechallenge with afatinib in patients with advanced NSCLC haboring sensitive EGFR mutation without T790M
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Progression free survival
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	Afatinib 40mg/day
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 NSCLC 2)EGFR mutation (exon19 deletion or L858R in exon 21) without T790M proven by rebiopsy after PD of prior therapy 3)Age: over 20 4)PS(ECOG): 0-1 5)Unresectable clinical stage IIIB/IV 6)Previously treated with EGFR-TKI (only 1 regimen) and lasted for more than 6 months 7)Previously treated with plutinum combination chemotherapy 8)After 3rd line therapy 9)Interval of radiation therapy: 4 weeks after thoracic RT and 1 week after non-thoracic RT 10)Measurable disease for RECIST 11)Adequate organ functions judged by laboratory tests 12)Life expectancy: over 3 months 13)Written informed consent
Key exclusion criteria	1)SCLC and sarcoma peoven by rebiopsy 2)Symptomatic brain metastases 3)Leptomeningeal carcinomatosis 4)Active double cancer 5)Severe allergic history 6)Pregnancy 7)Svere complication 8)Indicated for urgent RT 9)Allergic history for afatinib 10)Inadequate patients whom physitians considered
Target sample size	12

Research contact person
Name of lead principal investigator	Katsuyuki Kiura
Organization	Okayama University Hospital
Division name	Department of Respiratory Medicine
Address	2-5-1, Shikatacho, Okayama, Japan
TEL	086-223-7151
Email	pgjj77o3@s.okayama-u.ac.jp

Public contact
Name of contact person	Naohiro Oda
Organization	Okayama University Hospital
Division name	Department of Respiratory Medicine
Address	2-5-1, Shikatacho, Okayama, Japan
TEL	086-223-7151
Homepage URL
Email	pgjj77o3@s.okayama-u.ac.jp

Sponsor
Institute	Okayama University Hospital
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)

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 11 Month 30 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 11 Month 18 Day
Anticipated trial start date	2014 Year 12 Month 01 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 10 Month 30 Day
Last modified on	2019 Year 02 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018092