UMIN-CTR Clinical Trial

Public title

Phase II study of Pemetrexed and Bevacizumab in Plutinum Unfit patients with untreated advanced non-squamous non-small cell lung cancer(OSAKA-LCSG1201)

Acronym

OSAKA-LCSG1201

Scientific Title

Phase II study of Pemetrexed and Bevacizumab in Plutinum Unfit patients with untreated advanced non-squamous non-small cell lung cancer(OSAKA-LCSG1201)

Scientific Title:Acronym

OSAKA-LCSG1201

Region

Japan

Condition

non-small cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the efficacy and safety of Pemetrexed and Bevacizumab in plutinum unfit patients with untreated non-squamous NSCLC patients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Response rate

Key secondary outcomes

Progression-free survival, 1 year survival rate, Frequency and grade of adverse event

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

Pemetrexed
Bevacizumab

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

Not applicable

Gender

Male and Female

Key inclusion criteria

(1)Histologically or cytologically confirmed non-squamuous, non-small cell lung cancer
(2)Stage III/IV non-small cell lung cancer without any indications for radiotherapy or surgery
(3) Patient who unfit platinum
(4)Age 20=<
(5)ECOG performance status of 0 to 2
(6)With one or more measurable disease based on RECIST
(7) Interval
-Immune therapy, Endocrine therapy
>3wks
-Palliative radiotherapy >2wks
-Surgery >4wks
-thoracic drainage>1wks
-biopsy with dissection, indwelling port >2wks
-blood transfusion >2wks
(8)Adequate organ function, evaluated within 14 days before enrollment as
Neu >= 1,500 /mm3
Plt >= 10.0 x 10000 /mm3
hemoglobin >= 9.0 g/dL
T-bil =< 1.5 mg/dL
AST (GOT) ,ALT (GPT) =< 100 IU/L
Cr >= 1.5mg/dL
Proteinuria <1+
SpO2 >= 90%
(9)Expected to live over 3 months after administration days.
(10)Written informed consent from the patients.

Key exclusion criteria

(1)Symptomatic brain metastasis
(2) Have another active malignancy
(3) Current or previous history of hemoptysis
(4) Evidence of tumor invading large vessel on imaging
(5) Evidence of tumor invading trachea or main bronchus on imaging
(6) Have received radiation therapy to lesions of lung
(7) Currently have or have a history of a cardiac effusion which requires treatment
(8) Brain infarction within 1 year
(9) Problematic infection
(10) Scheduled operation
(11) Active radiation pneumonitis or esophagitis
(13) Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy
(14) Decision of ineligibility by a physician.

Target sample size

45

Name of lead principal investigator

1st name
Middle name
Last name	Takashi Kijima

Organization

Osaka University Hospital

Division name

Dept. of Respiratory Medicine

Zip code

Address

2-15 Yamada-oka, Suita, Osaka, Japan

TEL

06-6879-3833

Email

tkijima@imed3.med.osaka-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Masayoshi Higashiguchi

Organization

Osaka University Hospital

Division name

Dept. of Respiratory Medicine

Zip code

Address

2-15 Yamada-oka, Suita, Osaka, Japan

TEL

06-6879-3833

Homepage URL

Email

higashiguchi@imed3.med.osaka-u.ac.jp

Institute

OSAKA-LCSG

Institute

Department

Personal name

Organization

Nothing

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

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

Date of disclosure of the study information

2012

Year

12

Month

13

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

Terminated

Date of protocol fixation

2012

Year

08

Month

30

Day

Date of IRB

Anticipated trial start date

2012

Year

10

Month

01

Day

Last follow-up date

2015

Year

11

Month

30

Day

Date of closure to data entry

2015

Year

11

Month

30

Day

Date trial data considered complete

2015

Year

11

Month

30

Day

Date analysis concluded

2015

Year

11

Month

30

Day

Other related information

Registered date

2012

Year

12

Month

13

Day

Last modified on

2018

Year

12

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010360