UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of afatinib for non-small cell lung cancer acquired resistance to osimertinib (North Japan Lung Cancer Study Group 1801)
Acronym	Phase II study of afatinib for NSCLC acquired resistance to osimertinib (NJLCG1801)
Scientific Title	Phase II study of afatinib for non-small cell lung cancer acquired resistance to osimertinib (North Japan Lung Cancer Study Group 1801)
Scientific Title:Acronym	Phase II study of afatinib for NSCLC acquired resistance to osimertinib (NJLCG1801)
Region	Japan

Condition
Condition	Lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of afatinib for non-small cell lung cancer acquired resistance to osimertinib
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Disease control rate
Key secondary outcomes	Progression free survival, Response rate, Duration of response, 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	Afatinib at the dose of 40 mg is orally administered once daily and the administration is continued until progression disease or unacceptable toxicity
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1. Non-small cell lung cancer (NSCLC) 2. EGFR activating mutation (exon 19 deletion or exon 21 L858R) 3. Detected T790M mutation before treatment with osimertinib 4. Stage IIIB, IV, or recurrent NSCLC 5. Have a history of first or second generation EGFR-TKI treatment 6. Progression disease after treatment with osimertinib 7. Have measurable lesion by RECIST version 1.1 8. ECOG performance status 0-1 9. Estimated life expectancy at least 4 months 10. Adequate organ function for treatment with afatinib 11. Written informed consent
Key exclusion criteria	1. ILD or pulmonary fibrosis complication on chest X-ray 2. Other cancers 3. With severe complication 1). Uncontrollable pericardial effusion, pleural effusion, or ascites 2). Uncontrollable diabetes 3). Uncontrollable hypertension, angina pectoris, or heart failure 4). SVC syndrome or spinal cord pressure symptom 5). Severe infectious disease 4. Impossible to take drugs orally 5. History of serious drug allergies 6. Pregnancy, breast feeding, or hesitation in contraception 7. Other conditions not suitable for this study
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Makoto Maemondo
Organization	Iwate medical university
Division name	Division of pulmonary medicine, allergy, and rheumatology, Department of internal medicine
Zip code
Address	19-1 Uchimaru, Morioka, Japan
TEL	019-651-5111
Email	maemondo@gmail.com

Public contact
Name of contact person	1st name Middle name Last name Heisuke Saito
Organization	Iwate medical university
Division name	Division of pulmonary medicine, allergy, and rheumatology, Department of internal medicine
Zip code
Address	19-1 Uchimaru, Morioka, Japan
TEL	019-651-5111
Homepage URL
Email	fkfmh744@ybb.ne.jp

Sponsor
Institute	Iwate medical university
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	2017 Year 12 Month 15 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	Enrolling by invitation
Date of protocol fixation	2017 Year 10 Month 06 Day
Date of IRB	2018 Year 02 Month 01 Day
Anticipated trial start date	2018 Year 01 Month 04 Day
Last follow-up date	2020 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 12 Month 14 Day
Last modified on	2019 Year 06 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034710