UMIN-CTR Clinical Trial

Basic information
Public title	A phase I study Afatinib in Combination of Osimertinib in patients with Relapsed Non-Small Cell Lung Cancer after failure of prior Osimertinib
Acronym	A phase I study Afatinib in Combination of Osimertinib in patients with Relapsed Non-Small Cell Lung Cancer after failure of prior Osimertinib
Scientific Title	A phase I study Afatinib in Combination of Osimertinib in patients with Relapsed Non-Small Cell Lung Cancer after failure of prior Osimertinib
Scientific Title:Acronym	A phase I study Afatinib in Combination of Osimertinib in patients with Relapsed Non-Small Cell Lung Cancer after failure of prior Osimertinib
Region	Japan

Condition
Condition	Non-small cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To determine of dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended dose (RD) for the combination of osimertinib with afatinib for non-small cell lung cancer patients with EGFR active mutations after failure of osimertinib
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To determine of dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended dose (RD)
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Osimertinib 80mg day1~ + Afatinib day1~each dose cohort Cohort1 Afatinib 20mg Cohort2 Afatinib 30mg Cohort3 Afatinib 40mg until disease progression
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) Non-small cell lung cancer proven by histology and / or cytology with EGFR active mutation 2) Stage IIIB, IIIC, IV or postoperative / post chmoradiation therapy recurrence 3) prior osimertinib failure 4) patients who could treat with a 80mg dose of osimertinib 5) 20 years or older 6) performance status 0 or 1 7) Adequate organ function 8) At least one or more measurable lesion by RECIST 9) Written informed consent for translational research 10) Written informed consent
Key exclusion criteria	1) Patients who are difficult to treat enrolled doses due to toxicity of afatinib 2) History of drug-induced pneumonitis, Interstitial pneumonia 3) Symptomatic brain metastasis, leptomeningitis 4) Bone metastasis to treat by operation or radiation therapy 5) Uncontrollable pleural, peritoneal or pericardial effusion 6) Prior thoracic palliative radiotherapy within 2wks 7) SCLC transformation 8) History of active double cancer 9) Severe infection 10) Active HBV infection 11) No intention to birth control 12) Unstable psychic disorder 13) Under treatment of steroid therapy or immunosuppressive therapy 14) History of allergic reaction 15) Decision of ineligibility by a physician
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hiroshi Tanaka
Organization	Niigata Cancer Center Hospital
Division name	Department of Internal Medicine
Zip code
Address	2-15-3, Kawagishicho, Chuo-ku, Niigata
TEL	025-266-5111
Email	htanaka@niigata-cc.jp

Public contact
Name of contact person	1st name Middle name Last name Satoru Miura
Organization	Niigata Cancer Center Hospital
Division name	Department of Internal Medicine
Zip code
Address	2-15-3, Kawagishicho, Chuo-ku, Niigata
TEL	025-266-5111
Homepage URL
Email	miusat1118@niigata-cc.jp

Sponsor
Institute	Niigata Cancer Center Hospital
Institute
Department

Funding Source
Organization	Boehringer Ingelheim Japan
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
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	新潟県立がんセンター新潟病院内科（新潟県）、和歌山県立医科大学内科学第3講座（和歌山県）、久留米大学医学部内科学講座、呼吸器・神経・膠原病内科部門（福岡県）、関西医科大学附属病院呼吸器腫瘍内科（大阪府）

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 09 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	Preinitiation
Date of protocol fixation	2018 Year 02 Month 15 Day
Date of IRB
Anticipated trial start date	2018 Year 03 Month 09 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	2018 Year 02 Month 27 Day
Last modified on	2018 Year 02 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035902

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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