UMIN-CTR Clinical Trial

Public title

A Phase 2 study of Carboplatin plus Pemetrexed plus Bevacizumab as first-line therapy for stage3B/4 non-squamous non-small-cell lung cancer

Acronym

A Phase 2 study of Carboplatin plus Pemetrexed plus Bevacizumab as first-line therapy for stage3B/4 non-squamous non-small-cell lung cancer

Scientific Title

A Phase 2 study of Carboplatin plus Pemetrexed plus Bevacizumab as first-line therapy for stage3B/4 non-squamous non-small-cell lung cancer

Scientific Title:Acronym

A Phase 2 study of Carboplatin plus Pemetrexed plus Bevacizumab as first-line therapy for stage3B/4 non-squamous non-small-cell lung cancer

Region

Japan

Condition

Lung Cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The purpose of this study is to evaluate the efficacy and safety of Carboplatin plus Pemetrexed plus Bevacizumab as first-line therapy in patients with stage3B/4 nonsquamous non-small-cell lung cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I,II

Primary outcomes

response rate

Key secondary outcomes

Progression-free survival(PFS)
Overall survival(OS)
Safety

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

Carboplatin and Pemetrexed and Bevacizumab on Day1,every 3 weeks,up to 6 cycles. Achieved disease control without unacceptable toxicity receive Pemetrexed and Bevacizumab on Day1 every 3 weeks, until disease progression.

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

20

years-old

<=

Age-upper limit

75

years-old

>

Gender

Male and Female

Key inclusion criteria

1)Histologically or cytologically proven non-squamous non small cell lung cancer
2)Patients with Stage3B/4 or postoperative recurrence NSCLC
3)Chemo-naïve patient
4)Age:20 years to less than 75 years
5)ECOG Performance status 0-1
6)Patients who has measurable by RECIST(ver1.1)criteria
7)Patients who has the following periods
i.Palliative radiotherapy:1weeks
ii.Operation:4weeks
iii.Thoracic cavity drainage:2weeks
vi.Biopsy with incision,poet custody,and treatment to injury:2weeks
v.Aspiration biopsy cytology:1weeks
8)Adequate organ function
9)Life expectancy more than 3 months
10)Signed written informed consent

Key exclusion criteria

1)Uncontrolled infection or Serious medical complications
2)Uncontrolled pleural effusion or ascites
3)Brain metastases
4)Serious disease condition
5)Uncontrolled diabetes mellitus
6)Therapeutic anticoagulopathy
7)Uncontrolled hyper tension
8)Current or previous history of GI
perforation
9)interstitial lung disease or fibroid lung
10)history of drug-induced interstitial lung diseas
11)Current or previous history of hemoptysis
12)history of hemoptysis
13)Scheduling operation for examination time
14)Treatment history of carboplatin,pemetrexed,bevacizumab
15)Drug allergens
16)Multiple primary cancer
17)Serious psychiatric illness or psychological symptom
18)Women who are pregnant, lactating or with childbearing potential.
19)Ineligible based on decision of an investigator.

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Yoshiki Ishii

Organization

Dokkyo Medical University School of Medicine

Division name

Pulmonary Medicine and Clinical Immunology

Zip code

Address

880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi, 321-0293 JAPAN

TEL

0282-87-2151

Email

ishiiysk@dokkyomed.ac.jp

Name of contact person

1st name
Middle name
Last name	Yoshiki Ishii

Organization

Dokkyo Medical University School of Medicine

Division name

Pulmonary Medicine and Clinical Immunology

Zip code

Address

880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi, 321-0293 JAPAN

TEL

0282-87-2151

Homepage URL

Email

ishiiysk@dokkyomed.ac.jp

Institute

Dokkyo Medical University

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Southern Tohoku General Hospital

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

獨協医科大学病院（栃木県）
総合南東北病院（福島県）

Date of disclosure of the study information

2011

Year

02

Month

26

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

2009

Year

01

Month

06

Day

Date of IRB

Anticipated trial start date

2009

Year

01

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

02

Month

25

Day

Last modified on

2014

Year

09

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006066