UMIN-CTR Clinical Trial

Basic information
Public title	Prospective observational study on the key drug selection in advanced/recurrent EGFR mutation-positive non-small-cell lung cancer
Acronym	Prospective observational study on the key drug selection in advanced/recurrent EGFR mutation-positive non-small-cell lung cancer
Scientific Title	Prospective observational study on the key drug selection in advanced/recurrent EGFR mutation-positive non-small-cell lung cancer
Scientific Title:Acronym	Prospective observational study on the key drug selection in advanced/recurrent EGFR mutation-positive non-small-cell lung cancer
Region	Japan

Condition
Condition	Non-small cell lung cancer
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	1) To reveal the real world utilization of the key drugs such as 1st generation of EGFR-TKI, 2nd generation of EGFR-TKI, Osimertinib, immune checkpoint inhibitors (ICIs), and platinum doublets in the patients with EGFR mutation-positive advanced/recurrent non-Sq NSCLC, and search the best treatment sequence of these drugs. 2) Genetic analysis of the mechanisms of responsiveness and acquired resistance to Osimertinib.
Basic objectives2	Others
Basic objectives -Others	Data cllection of real world treatments
Trial characteristics_1	Others
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	To reveal real world clinical utility of Osimertinib in EGFR-mutant non-Sq NSCLC 1)Frequency of Osimertinib utilization after 1st or 2nd generation EGFR-TKI 2)Line of Osimertinib administration 3)Efficacy of Osimertinib 4)Toxicities of Osimertinib
Key secondary outcomes	1)To reveal real world treatments and their results for EGFR-mutant non-Sq NSCLC 2)To reveal the factors contributing to OS prolongation 3)Osimertinib-related part: 1.Frequency and success rate of re-biopsy 2.Efficacy of Osimertinib in CNS 3.Pattern, frequency, and severity of interstitial pneumonitis (IP) by Osimertinib 4)Osimertinib-unrelated part 1.Line of Nivolumab (and the other ICI monotherapy) administration 2.Response rate, disease control rate, and PFS of Nivolumab (and the other ICI monotherapy) in EGFR-mutated NSCLC 3.Accumulation and analysis of the cases who received an EGFR-TKI after ICIs. 5)To reveal interactions among different treatments especially that with ICI

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	I. Patients with histologically or cytologically confirmed EGFR mutation-positive advanced/recurrent non-Sq NSCLC (including minor mutation) II. Patients who received or are planning to receive any drug therapy for NSCLC after 01 June 2016. (Data are collected from the patients who actually received drug therapy after 01 June 2016.) III. Sufficient functions of the main organs IV. PS 0-2 at the start of initial drug therapy
Key exclusion criteria	Patients judged by the investigator to be unsuitable for the study
Target sample size	600

Research contact person
Name of lead principal investigator	1st name Fumio Middle name Last name Imamura
Organization	Osaka International Cancer Institute
Division name	Department of Thoracic Oncology
Zip code	5418567
Address	3-1-69 Otemae, Chuo-ku, Osaka 541-8567
TEL	+81-6-6945-1181
Email	imamura-fu@mc.pref.osaka.jp

Public contact
Name of contact person	1st name Fumio Middle name Last name Imamura
Organization	Osaka International Cancer Institute
Division name	Department of Thoracic Oncology
Zip code	5418567
Address	3-1-69 Otemae, Chuo-ku, Osaka 541-8567
TEL	+81-6-6945-1181
Homepage URL
Email	imamura-fu@mc.pref.osaka.jp

Sponsor
Institute	Osaka International Cancer Institute
Institute
Department

Funding Source
Organization	AstraZeneca
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	Osaka International Cancer Institute
Address	-1-69 Otemae, Chuo-ku, Osaka 541-8567
Tel	+81669721181
Email	imamura-fu@mc.pref.osaka.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 09 Month 10 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	524
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	Completed
Date of protocol fixation	2017 Year 09 Month 10 Day
Date of IRB	2017 Year 09 Month 27 Day
Anticipated trial start date	2017 Year 10 Month 01 Day
Last follow-up date	2020 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	No

Management information
Registered date	2017 Year 09 Month 04 Day
Last modified on	2020 Year 09 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033169