UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025878
Receipt number R000029747
Scientific Title Phase II trial of nivolumab following radiation therapy to bone metastases in patients with non-small cell lung cancer
Date of disclosure of the study information 2017/02/01
Last modified on 2021/01/30 09:45:50

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Basic information

Public title

Phase II trial of nivolumab following radiation therapy to bone metastases in patients with non-small cell lung cancer

Acronym

RT-Nivo NSCLC phase II

Scientific Title

Phase II trial of nivolumab following radiation therapy to bone metastases in patients with non-small cell lung cancer

Scientific Title:Acronym

RT-Nivo NSCLC phase II

Region

Japan


Condition

Condition

non-small cell lung cancer with bone metastasis

Classification by specialty

Pneumology Hematology and clinical oncology Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate antitumor effects of nivolumab following palliative radiation to bone metastases

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

Primary outcomes

Objective response rate

Key secondary outcomes

Progression free survival, overall survival, safety, and tolerability


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

Radiation therapy 20 Gy/5 fractions to bone metastasis, followed by nivolumab 3mg/kg administered 6 to 24 hours after the end of the radiation therapy. Then, nivolumab is given every two weeks until disease progression or stop of the treatment because of toxicity.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1) a histological or cytological diagnosis of non-small cell lung cancer
2) having bone metastasis suitable for palliative radiation therapy which had not been radiated
3) age above 20 years old
4) ECOG performance status of 0-2
5) Prior platinum-containing chemotherapy
6) Adequate organ function as documented by a WBC count of 3,000/microL or higher, hemoglobin of 9.0 g/dL or higher, platelet count of 100,000/microL or higher, serum creatinine of 1.5 mg/dL or lower, hepatic transaminases of 100 IU/L or lower, alanine aminotransferase of 100 IU/L or lower, total serum bilirubin of 1.8 mg/dL or lower, and PaO2 of 70 Torr or higher or SpO2 of 93% or higher at room air
7) having a measurable disease with CT or MRI
8) written informed consent

Key exclusion criteria

1) Positive for epidermal grow factor receptor activating mutation or ALK re-arrangement
2) Active malignancies within 2 years
3) Active infection requiring intravenous systemic therapy or hospital admission
4) A history of interstitial lung disease
5) A history of active, known autoimmune disease.
6) Requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications.
7) Active CNS metastasis
8) Carcinomatous meningitis
9) Positive for HBs antigen or HBV-DNA positive
10) Positive for HCV antibody
11) Pregnant or breast-feeding women
12) Any other patients whom the doctor judged to be unsuitable for this trial

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ikuo Sekine

Organization

University of Tsukuba Hospital

Division name

Department of Medical Oncology

Zip code


Address

Amakubo 2-1-1, Tsukuba-shi, ibaraki

TEL

029-853-3900

Email

isekine@md.tsukuba.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ikuo Sekine

Organization

University of Tsukuba Hospitgal

Division name

Department of Medical Oncology

Zip code


Address

Amakubo 2-1-1, Tsukuba-shi, ibaraki

TEL

029-853-3900

Homepage URL


Email

isekine@md.tsukuba.ac.jp


Sponsor or person

Institute

University of Tsukuba Hospital

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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 02 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

Terminated

Date of protocol fixation

2017 Year 02 Month 01 Day

Date of IRB

2017 Year 03 Month 07 Day

Anticipated trial start date

2017 Year 03 Month 07 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 01 Month 27 Day

Last modified on

2021 Year 01 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029747


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name