UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007475
Receipt number R000008808
Scientific Title A randomized phase II study of Erlotinib with or without Bevacizumab in NSCLC patients previouly treated with platinum-based chemotherapy containing bevacizumab. North Japan Lung Cancer Study Group Trial 1201
Date of disclosure of the study information 2012/03/09
Last modified on 2014/09/09 11:51:33

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Basic information

Public title

A randomized phase II study of Erlotinib with or without Bevacizumab in NSCLC patients previouly treated with platinum-based chemotherapy containing bevacizumab.
North Japan Lung Cancer Study Group Trial 1201

Acronym

Randomized phase II study of 2nd line Erlotinib with or without Bevacizumab (NJLCG1201)

Scientific Title

A randomized phase II study of Erlotinib with or without Bevacizumab in NSCLC patients previouly treated with platinum-based chemotherapy containing bevacizumab.
North Japan Lung Cancer Study Group Trial 1201

Scientific Title:Acronym

Randomized phase II study of 2nd line Erlotinib with or without Bevacizumab (NJLCG1201)

Region

Japan


Condition

Condition

non-squamous non-small cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate and compare the efficacy and safety of combination of bevacizumab and erlotinib versus erlotinib monothearpy in NSCLC patients who were previously treated with bevacizumab containing rejimen.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Progression Free Survival at 3 months after randomized

Key secondary outcomes

Response Rate, Disease Control Rate, Progression Free Survival, Overall Survival, Safety


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Erlotinib

Interventions/Control_2

Erlotinib + Bevacizumab

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)stage IIIB/IV or recurrence and histologically or cytologically confirmed non-squamous non-small lung cancer
2)history of 2 courses or more bevacizumab plus platinum doublet
3)known no active EGFR gene mutation
4)20 years or older
5)PS:0-2 (ECOG)
6)at least one measurable leision (RECIST)
7)patients who has the following periods
*the last prior chemotherapy:3weeks
*palliative radiotherapy(ex thorax):2weeks
*operation:4 weeks
*chest drainage:1weeks
*biopsy with incision, port custody,and treatment to injury:2weeks
8)adequate bone marrow,liver,and renal functions
9)a life expectancy of 3 months or more
10)written informed consent

Key exclusion criteria

1)Pulmonary disorder(idiopathic pulmonary fibrosis,interstitial lung disease, pneumoconiosis, active radiation pneumonia, etc.).
2)known active EGFR gene mutation
3)history of erlotinib or gefitinib treatment
4)inable of oral drug administration
5)current or previous histoty of hemoptysis(2.5ml)due to NSCLC
6)Risk of hemoptysis patients after thoracic radiation therapy is expected
7)With great vessel invasion
8)1cm or longer cavity in tumor
9)current or previous (within the last 1 year)history of GI perforation
10)history of myocardial infarction and cerebral infarction
11)planned surgery within study term
12)uncontrolled heypertension
13)symptomatic brain metastasis
14)history of drug allergy
15)massive,pleural effusion or ascites
16)uncontrolled infection or serious medical complications
17)active concomitant malignancy
18)mental disorder
19)pregnant or or lactating women or those who declined contraception
20)those judged not suitable by the attending physician

Target sample size

64


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shunichi Sugawara

Organization

Sendai Kousei Hospital

Division name

Department of Respiratory Medicine

Zip code


Address

4-15 Hirosemachi, Aobaku, Sendai, Miyagi 980-0873

TEL

022-222-6181

Email

swara357@cat-v.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shunichi Sugawara

Organization

Sendai Kousei Hospital

Division name

Department of Respiratory Medicine

Zip code


Address

4-15 Hirosemachi, Aobaku, Sendai, Miyagi 980-0873

TEL

022-222-6181

Homepage URL


Email

swara357@cat-v.ne.jp


Sponsor or person

Institute

North Japan Lung Cancer Study Group

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

YES

Study ID_1

NJLCG1201

Org. issuing International ID_1

North Japan Lung Cancer Study Group

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2012 Year 03 Month 09 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

2012 Year 02 Month 16 Day

Date of IRB


Anticipated trial start date

2012 Year 03 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 03 Month 09 Day

Last modified on

2014 Year 09 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008808


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name