UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003736
Receipt number R000004511
Scientific Title Phase 2 study of Pemetrexed + Carboplatin + Bevacizumab as first line therapy for nonsquamous non-small cell lung cancer without EGFR Mutation (CJLSG0909)
Date of disclosure of the study information 2010/06/11
Last modified on 2019/03/31 05:47:21

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Basic information

Public title

Phase 2 study of Pemetrexed + Carboplatin + Bevacizumab as first line therapy for nonsquamous non-small cell lung cancer without EGFR Mutation (CJLSG0909)

Acronym

Pemetrexed + Carboplatin + Bevacizumab as first line therapy for nonsquamous non-small cell lung cancer without EGFR Mutation

Scientific Title

Phase 2 study of Pemetrexed + Carboplatin + Bevacizumab as first line therapy for nonsquamous non-small cell lung cancer without EGFR Mutation (CJLSG0909)

Scientific Title:Acronym

Pemetrexed + Carboplatin + Bevacizumab as first line therapy for nonsquamous non-small cell lung cancer without EGFR Mutation

Region

Japan


Condition

Condition

Advanced non-squamous non-small cell lung cancer without EGFR Mutation

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of combination therapy with pemetrexed, carboplatin and bevacizumab for non-squamous non small cell lung cancer patients without epidermal growth factor receptor mutation.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Response rate

Key secondary outcomes

Adverse events
Disease control rate
Overall survival
Progression free survival


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

Patients receive Pemetrexed 500mg/m2 day1 + Carboplatin AUC6 day1 + Bevacizumab 15mg/kg day1, q3w, 4-6 cycles.
Patients who achieved disease control receive Pemetrexed 500mg/m2 day1 + Bevacizumab 15mg/kg day1, q3w 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



Eligibility

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 EGFR wild type
3) Patients with stage IIIB or IV, or recurrent disease after surgery and was not a candidate for curative radiotherapy
4) No prior chemotherapy
5) Patient who has measurable lesion by RECIST
6) Age: 20-74
7) ECOG PS: 0-1
8) Adequate organ function
9) Life expectancy more than 3 months
10) Written informed consent

Key exclusion criteria

1) Brain metastasis
2) Hemoptysis (>=2.5ml)
3) Active infection
4) Fever
5) Serious disease condition
6) Active double cancer
7) Cavity fluid retention difficult to control
8) Severe drug allergy
9) Receiving anticoagulant drug (except Aspirin under 325mg/day)
10) Active GI bleeding or inflammation in the abdominal cavity.
11) Pregnancy or lactation
12) Patients whose participation in the trial is judged to be inappropriate by the attending doctor

Target sample size

52


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroyuki Taniguchi

Organization

Tosei General Hospital

Division name

Respiratory medicine and allergy

Zip code


Address

160 Nishi-oiwake-cho, Seto, Aichi, Japan

TEL

0561-82-5101

Email

lung@tosei.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tomoki Kimura

Organization

Tosei General Hospital

Division name

Respiratory medicine and allergy

Zip code


Address

160 Nishi-oiwake-cho, Seto, Aichi, Japan

TEL

0561-82-5101

Homepage URL


Email

lung@tosei.or.jp


Sponsor or person

Institute

Central Japan Lung Study Group

Institute

Department

Personal name



Funding Source

Organization

Central Japan Lung Study Group

Organization

Division

Category of Funding Organization

Other

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

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

2010 Year 06 Month 11 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

Main results already published

Date of protocol fixation

2010 Year 05 Month 06 Day

Date of IRB

2010 Year 06 Month 01 Day

Anticipated trial start date

2010 Year 06 Month 01 Day

Last follow-up date

2015 Year 04 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 06 Month 11 Day

Last modified on

2019 Year 03 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004511


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name