UMIN-CTR Clinical Trial

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

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

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Clinical Research Support Center Kyushu

Institute

Department

Personal name

Organization

AstraZeneca K.K.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

07

Month

03

Day

URL releasing protocol

Publication of results

Partially published

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

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 related information

Registered date

2016

Year

05

Month

31

Day

Last modified on

2022

Year

04

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025991