UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of osimertinib in patients with non-small cell lung cancer who acquired resistance to afatinib
Acronym	Phase II study of osimertinib in patients with non-small cell lung cancer who acquired resistance to afatinib (ALCSG-04)
Scientific Title	Phase II study of osimertinib in patients with non-small cell lung cancer who acquired resistance to afatinib
Scientific Title:Acronym	Phase II study of osimertinib in patients with non-small cell lung cancer who acquired resistance to afatinib (ALCSG-04)
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy of osimertinib in patients harboring EGFR T790M mutation who acquired resistance to afatinib as first line.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Response rate
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Eligibility includes; 1. Patients of lung cancer diagnosed with pathological findings and clinical stage from IIIA to IV. 2. Patients harboring active EGFR gene mutations. 3. Patients having one or more measurable lesions based on RECIST v1.1. 4. Patients aged 20 and over 20, and less than 75 years. 5. Patients who are not treated with chemotherapy, EGFR-TKIs, and Immuno-checkpoint blockades. 6. Patients who can take EGFR-TKIs orally. 7. Patients having adequate organ function. 8. Letter of consent.
Key exclusion criteria	Patients are excluded if they have; 1. Severe concomitant disease. 2. Severe history oh hypersensitivity. 3. Severe heart disease or arrhythmia. 4. Interstitial pneumoniae. 5. Active infection. 6. Active peptic ulcer. 7. Active double cancer. 8. Symptomatic brain metastasis.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Takaaki Middle name Last name Sasaki
Organization	Asahikawa Medical University Hospital
Division name	Respiratory Center
Zip code	078-8510
Address	2-1-1-1 Midorigaoka-higashi, Asahikawa-shi, Hokkaido, 078-8510 Japan
TEL	0166-65-2111
Email	yryohei@asahikawa-med.ac.jp

Public contact
Name of contact person	1st name Kaori Middle name Last name Onishi
Organization	Asahikawa Medical University Hospital
Division name	Respiratory Center
Zip code	078-8510
Address	2-1-1-1 Midorigaoka-higashi, Asahikawa-shi, Hokkaido, 078-8510 Japan
TEL	0166-65-2111
Homepage URL
Email	k-onishi@asahikawa-med.ac.jp

Sponsor
Institute	Asahikawa Medical University Hospital
Institute
Department

Funding Source
Organization	Asahikawa Medical University Hospital, Respiratory center
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Asahikawa Lung Cancer Study Group(ALCSG)
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Asahikawa Medical University Hospital
Address	2-1-1-1 Midorigaoka-higashi, Asahikawa-shi, Hokkaido, 078-8510 Japan
Tel	0166-65-2111
Email	k-onishi@asahikawa-med.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	2017 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
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	Open public recruiting
Date of protocol fixation	2017 Year 07 Month 01 Day
Date of IRB	2017 Year 05 Month 01 Day
Anticipated trial start date	2017 Year 08 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	No mention.

Management information
Registered date	2017 Year 07 Month 10 Day
Last modified on	2020 Year 01 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031670