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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028071
Receipt No. R000030717
Scientific Title Osimertinib combined bevacizumab in untreated epidermal growth factor receptor mutaeted non-small-cell lung cancer patients with malignant pleural and/or pericardial effusion -phase II trial-
Date of disclosure of the study information 2017/07/04
Last modified on 2019/07/29

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Basic information
Public title Osimertinib combined bevacizumab in untreated epidermal growth factor receptor mutaeted non-small-cell lung cancer patients with malignant pleural and/or pericardial effusion -phase II trial-
Acronym SPIRAL II Study
Scientific Title Osimertinib combined bevacizumab in untreated epidermal growth factor receptor mutaeted non-small-cell lung cancer patients with malignant pleural and/or pericardial effusion -phase II trial-
Scientific Title:Acronym SPIRAL II Study

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 on combination therapy of osimertinib and bevacizumab in patients with untreated epidermal growth factor receptor mutated non-small-cell lung cancer patients with malignant pleural and/or pericardial effusion..
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Primary outcomes 1 year Progression free survival rate (1-year PFS rate)
Key secondary outcomes Rresponse rate (RR)
Progression free survival (PFS)
Overall survival (OS)
Pleural or pericardial drainage free survival

Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Dynamic allocation
Institution consideration

No. of arms 1
Purpose of intervention Treatment
Type of intervention
Interventions/Control_1 Osimertinib 80mg, po once daily and bevacizumab 15mg/kg, iv every 3 weeks are administered until PD as 21 days of 1 cycle (or the meeting of discontinuation criteria).

Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients with untreated stage IV or post-operative recurrence who was histologically or cytologically confirned as non-small-cell lung cancer.(excluding squamous carcinoma) When chemotherapy is carried out in patients with post-operative recurrence, it is eligible if four weeks passed after the final treatment of prior chemotherapy. Radiation therapy in the case of radical radiation to chest:>=12 weeks after the day of final radiation. In the case of radiation to other than chest:>=2 weeks after the day of final radiation Operation/treatment(excluding chest drainage,pericardial drainage): >=4 weeks after the day of final operation/treatment Chest drainage,pericardial drainage:>=2 weeks after the day of treatment
2.Patients with malignant pleural and pericardial effusion.(in principle, cytodiagnosis is conducted. However, it is eligible when it can be clearly diagnosed as carcinomatous pleurisy and malignant pericardial effusion by image test and clinical surveillance even if a result of malignancy is not taken).
3.Patients with EGFR mutation positive.
4.Patients capable of treatment with oral medicine.
5.Patients have at least one measurable lesion accorring to RECIST v.1.1 criteria. 6.Performance Status(ECOG)0-2.
7.Patients capable of participating this study under at least 2 weeks admission to the hospital or corresponding management,in principle.
8.Patients are >=20 years of age (at informed consent).
9.Patients for whom bone marrow,hepatic, and renal functions have all been confirmed as normal within 14 days prior to enrollment according to the following clinical test standards(it is eligible on the same day 2 weeks before the enrolment days):
Neutrophil count >= 1.5x10^3/uL
Platelet count >= 100x10^3/uL
Hemoglobin >= 9.0 g/dl
AST, ALT <=100U/L
Total bilirubin <=1.5mg/dL
Creatinine <=2.0mg/dL
SpO2(Room air >=90%
Proteinuria <1+
10.Patients with life expectancy of at least 3 months.
11.Patients providing the written informed consent.
Key exclusion criteria 1.Patients whose chest drainage is no problem for pleural effusion,but who have pleurodesis.
2.Patients with pulmonary disorders such as idiopathic pulmonary fibrosis,interstitial pneumonia, pneumoconiosis,active radiation pneumonitis and drug-induced pneumonia. 3.Anamnesis and complication of hemoptysisor the following bloody sputum. bloody sputum which occurs continuously bloody sputum which needs the continuous administration of oral hemostatics bloody sputum necessary for homostatic injection. 4.Patients with cavity and tumor invasion to large vessels. 5.Infectious disorder need for intravenous injection of antibacterial drug and antimycotics. 6.Patients with corneal ulcer.7.Patients with any of the following risk of QTc prolongation:
Mean resting mean corrected QT interval >470msec. Any clinically important abnormalities in rhythm,conduction or morphology of resting ECG. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events. 8.Patients who are pregnant,nursing or possibly pregnant. 9.Patients with brain metastasis accompanying symptoms. 10.Active double cancer. 11.Patients with uncontrollable diabetes mellitus. 12.Patients who have complications to be clinical problem. 13.Patients judged as severe or uncontrollable systemic disease by investigators. For example,patients is judged by investigators that the participation in the study is undesirable or that the compliance of the protocol is difficult by uncontrollable hypertension and active hemorrhagic diathesis or hepatitis B,hepatitis C and active infections such as human immunodeficiency virus infection.
14.Patients with anamneses such as refractory nausea and vomiting,chronic digestive organ disease or pharmaceutical preparation aphagia,or gastroeneterectomy that may remarkably influence osimertinib absorption.
15.Patients whose wound healing cannot be confirmed.
16.Patients without intention to prevent pregnancy during a study period.
Target sample size 30

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, Kamigyo-ku, Kyoto, Japan
TEL 075-251-5513

Public contact
Name of contact person
1st name Osamu
Middle name
Last name Hiranuma
Organization Otsu Municipal Hospital
Division name Department of Respiratory Medicine
Zip code 520-0804
Address 2-9-9 Motomiya, Otsu, Shiga , Japan
TEL 077-522-4607
Homepage URL

Institute Clinical Research Support Center Kyushu

Funding Source
Organization AstraZeneca K.K.
Category of Funding Organization Profit organization
Nationality of Funding Organization JAPAN

Other related organizations
Name of secondary funder(s)

IRB Contact (For public release)
Organization Clinical Research Network Fukuoka Certified Review Board
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka, Fukuoka
Tel 092-643-7171

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2

Institutions 京都府立医科大学付属病院(京都府)、地方独立行政法人総合病院国保旭中央病院()、宇治徳洲会病院(京都府)、市立大津市民病院(滋賀県)、京都第一赤十字病院(京都府)、千葉西総合病院(千葉県)、社会医療法人鹿児島愛心会大隅鹿屋病院(鹿児島県)、医療法人徳洲会湘南藤沢徳洲会病院(神奈川県)、金沢医科大学病院(石川県)、福岡大学病院(福岡県)、京都山城総合医療センター(京都府)、国立病院機構東近江総合医療センター(滋賀県)、独立行政法人国立病院機構京都医療センター(京都府)、地方独立行政法人栃木県立がんセンター(栃木県)、和泉市立総合医療センター(大阪府)、藤田医科大学病院(愛知県)、医療法人徳洲会八尾徳洲会総合病院(大阪府)、JCHO京都鞍馬口医療センター(京都府)、国立病院機構金沢医療センター(石川県)、京都中部総合医療センター(京都府)、医療法人財団康生会武田病院(京都府)、京都府立医科大学附属北部医療センター(京都府)、JCHO神戸中央病院(兵庫県)、パナソニック健康保険組合松下記念病院(大阪府)、日本赤十字社京都第二赤十字病院(京都府)、帝京大学医学部附属病院(東京都)、市立福知山市民病院(京都府)、独立行政法人国立病院機構大牟田病院(福岡県)、京都大学医学部附属病院(京都府)、富山県立中央病院(富山県)、独立行政法人国立病院機構長崎医療センター(長崎県)、医療法人社団洛和会洛和会音羽病院(京都府)

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 04 Day

Related information
URL releasing protocol
Publication of results Unpublished

URL related to results and publications
Number of participants that the trial has enrolled
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 Open public recruiting
Date of protocol fixation
2017 Year 02 Month 28 Day
Date of IRB
2017 Year 05 Month 30 Day
Anticipated trial start date
2017 Year 07 Month 01 Day
Last follow-up date
2021 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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Management information
Registered date
2017 Year 07 Month 04 Day
Last modified on
2019 Year 07 Month 29 Day

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