UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004296
Receipt number R000005134
Scientific Title A phase II trial of gefitinib in combination with bevacizumab as first line therapy for advanced non-small-cell lung cancer with mutated EGFR
Date of disclosure of the study information 2010/10/01
Last modified on 2012/10/17 19:11:33

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Basic information

Public title

A phase II trial of gefitinib in combination with bevacizumab as first line therapy for advanced non-small-cell lung cancer with mutated EGFR

Acronym

A phase II trial of gefitinib in combination with bevacizumab as first line therapy for advanced non-small-cell lung cancer with mutated EGFR

Scientific Title

A phase II trial of gefitinib in combination with bevacizumab as first line therapy for advanced non-small-cell lung cancer with mutated EGFR

Scientific Title:Acronym

A phase II trial of gefitinib in combination with bevacizumab as first line therapy for advanced non-small-cell lung cancer with mutated EGFR

Region

Japan


Condition

Condition

non-small-cell lung cancer

Classification by specialty

Medicine in general Pneumology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To evaluate the efficacy of the combination chemotherapy (gefitinib and bevacizumab) in advanced non-small cell lung cancer with mutated EGFR

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

PFS

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

gefitinib, 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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. pathologically proven non-squamous non-small cell lung cancer
2. harboring active EGFR mutation other than exon 20 T790M
3. stage IV or ineligibility as candidates for curative treatment
4. measurable tumor sites
5. no prior chemotherapy
no prior systemic anticancer therapy
6. ECOG PS of 0 to 1
7. appropriate organ function
8. expected to live for more than 3 months
9. acquisition of written informed consent

Key exclusion criteria

1. symptomatic brain metastasis
2. pts with hemoptysis with 2.5mL or more
3. pts with radiological findings of tumor invasion to major vessels (i.e. aorta) and cavity lesion
4. pts with bleeding tendency
pts who need continuous use of antithrombotic agents
5. candidate for curative radiation therapy
6. have a history of severe drug allergy
7. woman who is pregnant or wishing to become pregnant
8. pts with massive pleural and cardiac effusion and ascites that need to be immediately treated
9. pts with active co-morbidities including severe conditions of heart diseases, infections, uncontrollable diabetes, uncontollable hypertension, interstitial pneumonia, active hepatitis and thrombotic disease.

Target sample size

42


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Katsuyuki Kiura

Organization

Okayama University Hospital

Division name

Department of Respiratory Medicine

Zip code


Address

2-5-1, Shikatacho, Okayama, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Okayama University Hospital

Division name

Department of Respiratory Medicine

Zip code


Address

2-5-1, Shikatacho, Okayama, Japan

TEL


Homepage URL


Email



Sponsor or person

Institute

Okayama 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

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 10 Month 01 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

Completed

Date of protocol fixation

2010 Year 09 Month 12 Day

Date of IRB


Anticipated trial start date

2010 Year 10 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

2010 Year 09 Month 29 Day

Last modified on

2012 Year 10 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005134


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name