UMIN-CTR Clinical Trial

Public title

Randomized phase II study with or without adjuvant immunotherapy of alpha-GalCer-pulsed dendritic cells in the patients with completely resected stage II-IIIA non-small cell lung cancer

Acronym

Randomized phase II of adjuvant immunotherapy using alpha-GalCer-pulsed dendritic cells in completely resected stage II-IIIA non-small cell lung cancer (RADCLC)

Scientific Title

Randomized phase II study with or without adjuvant immunotherapy of alpha-GalCer-pulsed dendritic cells in the patients with completely resected stage II-IIIA non-small cell lung cancer

Scientific Title:Acronym

Randomized phase II of adjuvant immunotherapy using alpha-GalCer-pulsed dendritic cells in completely resected stage II-IIIA non-small cell lung cancer (RADCLC)

Region

Japan

Condition

stage II-IIIA non-small cell lung cancer

Classification by specialty

Pneumology

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To verify the efficacy of adjuvant immunotherapy with alpha-GalCel pulsed dendritic cells in patients with completely resected stage II or IIIA non-small cell lung cancer followed by adjuvant chemotherapy with cisplatin and vinorelbine

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

disease free survival at 2 years

Key secondary outcomes

NKT-specific immune response
safety
overall survival

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

intravenous administration of alpha-GalCel pulsed dendritic cells on day7, 14, 49 and 56

Interventions/Control_2

no treatment with alpha-GalCel pulsed dendritic cells

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

20

years-old

<=

Age-upper limit

75

years-old

>

Gender

Male and Female

Key inclusion criteria

1) Patients for whom non-small cell lung cancer is confirmed histologically
2) Patients underwent at least lung lobectomy including elective or non-elective dissection of hilar or mediastinal lymph node
3) Complete resection is judged (Complete resection is defined to be the situation that tumor is completely removed grossly at the time of operation and tumor cells are not noted pathologically on the resection line.)
4) The pathological stage is IIA, IIB, IIIA.
5) At the time of enrollment, patients should be at least 20 years old and younger than 75 years old.
6) no recurrence at the time of enrollment
7) PS (ECOG; Eastern Cooperative Oncology Group) is 0-1.
8) Trial treatment can be started within 4 to 16 weeks after 3-4 cycles of adjuvant chemotherapy with cisplatin and vinorelbine.
9) Functions of the bone marrow, liver, kidney, and lung etc are maintained, satisfying the following conditions. (The following data should be the ones within 2 weeks before enrollment. The same day of the week 2 weeks before enrollment can be included.)
*Neutrophil count >=3,000/mm3
*Platelet count >=75,000/mm3
*Hemoglobin concentration>=9 g/dL
*Serum creatinine <=1.5 mg/dL
*Total bilirubin <=2.0 mg/dL
*AST/ALT <=2.0 X ULN of normal values in each institution
*SpO2 >=93%
10) NKT cells are detected at least 10 cells in 1 ml of peripheral blood.
11) After the details of the trial are explained sufficiently before enrollment in this trial, written consent by patients themselves should be obtained.

Key exclusion criteria

1) Serious concomitant disease including severe infectious disease or malnutrition.
2) Postoperative pleural effusion or ascites or cardiac effusion which need to be controlled.
3) The patient who have simultaneous malignancy or who have metachronous malignancy within 5 years-disease free interval.
4) Concurrent corticosteroid therapy
5)Autoimmune disease
6) History of hepatitis
7) Positive response to HIV, hepatitis C virus or human T cell lymphotrophic virus antibodies or those with HBs antigen.
8) Severe cardiac disease(NYHA class III or IV) or severe pulmonary disease (greater than Hugh-Jones Classification III)
9) History of hyper-reactivity to albmin
10) Pregnancy or lactation
11) Contraindication to apheresis (angina, greater than atrioventricular block 2 degree, WPW syndrome, complete left bundle branch block, systolic blood pressure with 90 Torr or greater than 170 Torr)
12) The patients have been judged to be inappropriate to participate in this study by principal investigator.

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Yukito Ichinose

Organization

National Hospital Organization Kyushu Cancer Center

Division name

Clnical Research Institute

Zip code

Address

3-1-1, Notame, Minami-ku, Fukuoka 811-1395, Japan

TEL

092-541-3231

Email

Name of contact person

1st name
Middle name
Last name	Mitsuhiro Takenoyama

Organization

National Hospital Organization Kyushu Cancer Center

Division name

Department of Thoracic Oncology

Zip code

Address

3-1-1, Notame, Minami-ku, Fukuoka 811-1395, Japan

TEL

092-541-3231

Homepage URL

Email

Institute

National Hospital Organization Kyushu Cancer Center

Institute

Department

Personal name

Organization

National Hospital Organization

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

国立病院機構九州がんセンター（福岡）、国立病院機構名古屋医療センター（愛知）
National Hospital Organization Kyushu Cancer Center (Fukuoka), National Hospital Organization Nagoya Medical Center (Aichi),

Date of disclosure of the study information

2013

Year

04

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Open public recruiting

Date of protocol fixation

2013

Year

02

Month

25

Day

Date of IRB

Anticipated trial start date

2013

Year

03

Month

22

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

04

Month

01

Day

Last modified on

2013

Year

04

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012145