UMIN-CTR Clinical Trial

Basic information
Public title	A phase II trial on efficacy and safety of osimertinib in elderly EGFR T790M-positive non-small-cell lung cancer patients who progressed during prior EGFR-TKI treatment or had recurrence
Acronym	SPIRAL Study
Scientific Title	A phase II trial on efficacy and safety of osimertinib in elderly EGFR T790M-positive non-small-cell lung cancer patients who progressed during prior EGFR-TKI treatment or had recurrence
Scientific Title:Acronym	SPIRAL Study
Region	Japan

Condition
Condition	advanced / recurrent non-small cell lung cancer (NSCLC)
Classification by specialty	Medicine in general Pneumology Hematology and clinical oncology Chest surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	We evaluate the efficacy and safety of osimertinib in elderly NSCLC harbouring EGFR (activating) mutation and T790M positive NSCLC patients with ineffective for prior EGFR-TKI treatment or with recurrence. In addition, we prospectively investigate about positive/negative concordance rate of T790M between tumour tissue or humoral specimen and plasma DNA.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Objective Response Rate (ORR)
Key secondary outcomes	Progression Free Survival (PFS) Overall Survival (OS) Disease Control Rate (DCR) Safety Positive/negative concordance rate of T790M between tumour tissue or humoral specimen and plasma DNA

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, o.d. is orally administered. Administered until PD (or the meeting of discontinuation criteria).
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	75 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Patients with stage IIIB/IV whose stage was histologically or cytologically confirmed as non-small-cell lung cancer and post-operative recurrence 2.Patients with recurrence after the effect of higher than SD was observed or not effective (less than stable disease (SD) in best overall response according to RECIST) by treatment of EGFR-TKI (e.g.: such as erlotinib, gefitinib, afatinib) for non-small-cell lung cancer 3.T790M positive after disease progression 4.Patients capable of treatment with oral medicine 5.Patients have at least one measurable lesion according to RECIST criteria 6.Performance Status(ECOG) 0-1 7.In principle, Patients capable of participating this study under at least 2 weeks admission to the hospital or corresponding management 8.Patients are >75 years of age (age at the time of enrollment). 9.Patients for whom bone marrow, hepatic, and renal functions have all been confirmed as normal 10.Patients with life expectancy of at least 3 months
Key exclusion criteria	1.Patients who have treatment history of osimertinib and other 3rd generation EGFR-TKI. 2.Patients with pulmonary disorders such as Idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, active radiation pneumonitis and drug-induced pneumonia. 3.Patients with infectious disorder need for intravenous injection of antibacterial drug and antimycotics. 4.Patients unable to swallow oral medications. 5.Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inhibitors of CYP3A4 (at least 1 week prior) and potent inducers of CYP3A4 (at least 3 week prior). All patients must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer/inhibitory effects on CYP3A4. 6.Patients currently receiving checkpoint inhibitor or with treatment history. 7.Patients with any of the following cardiac criteria: 1)Mean resting corrected QT interval (QTc using Fredericia's formula) > 470 msec 2)Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block) 3)Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval 8.Patients who are pregnant, nursing or possibly pregnant. 9.Patients with brain metastasis accompanying symptoms. 10.Patients with active double cancer. 11.Patients with uncontrollable diabetes mellitus. 12.Patients who have complications to be clinical problem (Such as uncontrollable cardiac disease, severe cardiac arrhythmia to need medical treatment, sustained serious diarrhoea)
Target sample size	35

Research contact person
Name of lead principal investigator	1st name JUNJI Middle name Last name UCHINO
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Pulmonary Medicine
Zip code	602-8566
Address	465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, JAPAN.
TEL	075-251-5513
Email	uchino@koto.kpu-m.ac.jp

Public contact
Name of contact person	1st name AKIRA Middle name Last name NAKAO
Organization	Faculty of Medicine, Fukuoka University
Division name	Department of Respiratory Medicine
Zip code	814-0180
Address	8-19-1 Nanakuma, Jonan-ku, Fukuoka 814-0180, Japan
TEL	092-801-1011
Homepage URL
Email	akiran@fukuoka-u.ac.jp

Sponsor
Institute	Clinical Research Support Center Kyushu
Institute
Department

Funding Source
Organization	AstraZeneca K.K.
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	Clinical Research Network Fukuoka Certified Review Board
Address	3-1-1 Maidashi, Hig ashi-ku, Fukuoka.
Tel	092-643-7171
Email	mail@crnfukuoka.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	2016 Year 07 Month 03 Day

Related information
URL releasing protocol
Publication of results	Partially published

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	Completed
Date of protocol fixation	2016 Year 03 Month 01 Day
Date of IRB	2016 Year 07 Month 27 Day
Anticipated trial start date	2016 Year 08 Month 01 Day
Last follow-up date	2019 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 05 Month 31 Day
Last modified on	2022 Year 04 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025991