UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016550
Receipt number R000019209
Scientific Title Untreated IIIB/IV period with the EGFR mutation in the gene, phase II study of Gefitinib and the pemetrexed / bevacizumab combination maintenance therapy after Gefitinib and the cisplatin / pemetrexed / bevacizumab combination induction therapy for non-squamous epithelium non-small cell lung cancer of the latter recurrence
Date of disclosure of the study information 2015/02/16
Last modified on 2016/08/17 16:13:22

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Untreated IIIB/IV period with the EGFR mutation in the gene, phase II study of Gefitinib and the pemetrexed / bevacizumab combination maintenance therapy after Gefitinib and the cisplatin / pemetrexed / bevacizumab combination induction therapy for non-squamous epithelium non-small cell lung cancer of the latter recurrence

Acronym

Untreated IIIB/IV period with the EGFR mutation in the gene, phase II study

Scientific Title

Untreated IIIB/IV period with the EGFR mutation in the gene, phase II study of Gefitinib and the pemetrexed / bevacizumab combination maintenance therapy after Gefitinib and the cisplatin / pemetrexed / bevacizumab combination induction therapy for non-squamous epithelium non-small cell lung cancer of the latter recurrence

Scientific Title:Acronym

Untreated IIIB/IV period with the EGFR mutation in the gene, phase II study

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

We examine Gefitinib and Gefitinib after the cisplatin / pemetrexed / bevacizumab combination induction therapy and efficacy and safety of the pemetrexed / bevacizumab combination maintenance therapy for non-squamous epithelium non-small cell lung cancer of the postoperative recurrence untreated IIIB/IV period with the EGFR mutation in the gene.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

1-year progression free survival rate

Key secondary outcomes

RR response rate
DCP disease Control proportion
OS overall survival
PFS progression free survival
AEs Adverse Events


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Randomization phase II study of the maintenance therapy with chemotherapy non-enforcement IIIB/IV period, pemetrexed following induction therapy with pemetrexed / cisplatin for patients with postoperative recurrent non-squamous epithelium non-small cell lung cancer or carboplatin

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 Histologically or cytologically confirmed non-squamuous, non-small cell lung cancer and stage IV or recurrent non-small cell lung cancer
2 A stage IIIB the clinic that radical irradiation is impossible of or stage IV and postoperative recurrence symptom example.
3 With the EGFR active form mutation in the gene more than G719X, 19del, L858R, one one of L861Q.
4 The case that recurred after the above after last administration for half a year of chemotherapy non-enforcement or the postoperative adjuvant chemotherapy.
We exclude the case given Gefitinib or pemetrexed as postoperative adjuvant chemotherapy.
Also, we do not include the picibanil which we used in pleurodesis and the minocycline in chemotherapy.
5 The age of the agreement acquisition day is a case younger than 75 years 20 years old or older.
6 ECOG Performance Status 0-1
7 With one or more measurable lesions based on RECIST version 1.1
8 Adequate organ function
9 The case that the survival that is more three months or more than the treatment starting date can expect.
10 An orally-available case.
11 The case that an agreement by the free will of the patients is obtained in a document about participation of this study.

Key exclusion criteria

1) The case that a squamous cancer ingredient accounts for more than 50% in the case of mixed type with the squamous cancer.
2) A mixed case with small cell lung cancer.
3) We have EGFR resistance gene mutation (T790M).
4) With the symptom or metastases to brain case to need treatment such as a steroid or the antispasmodic.
5) The case with a history of the hemoptysis or the merger.
6) The case with a history, the merger of the following sputum bloody.d
7) A case that was given the radiotherapy for the chest.
8) It is a case of after the palliative irradiation for bone metastases or the metastases to brain except the primary tumor for less than two weeks.
9) The invasion of the primary tumor is found in in great vessels in trachea or lobar bronchus or the TNM classification T4 of the lung cancer handling agreement revision seventh edition partly.
10) A case with the superior vena caval syndrome.
11) A case with the interstitial pneumonia that is clear by chest CT or pulmonary fibrosis.
12) The case with a serious infection.
13) The case with serious complications.
14) The case with pleural effusion, ascitic fluid requiring treatment such as the drainage and the pericardial fluid.
15)A case with the multiple primary cancer of the activity.
16)A case with a history of serious drug allergy.
17)Uncontrollable hypertension < 160/100
18) A case with a history of less than one year before merger of cerebrovascular disorder with the symptom or registration.
19) Need to antiplatelet therapy or anticoagulation therapy without Aspirin 325 mg/day
20) Gastrointestinal perforation within 1 year
21) The case that it was judged mental disorder to become the clinical problem to have difficulty in registration to this study.
22) With pregnancy and the pregnant likelihood or women nursing or men in hope of fertility.
23)Inappropriate for this study judged by the attending physician


Target sample size

27


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Seisuke Nagase

Organization

International University of Health and Welfare

Division name

Respiratory Disease Center

Zip code


Address

1-4-3 Mita, Minato-ku, Tokyo, Japan

TEL

03-3451-8121

Email

snagase@iuhw.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Seisuke Nagase

Organization

International University of Health and Welfare

Division name

Respiratory Disease Center

Zip code


Address

1-4-3 Mita, Minato-ku, Tokyo, Japan

TEL

03-3451-8121

Homepage URL


Email

snagase@iuhw.ac.jp


Sponsor or person

Institute

International University of Health and Welfare

Respiratory Disease Center

Institute

Department

Personal name



Funding Source

Organization

non

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

東京医科大学病院 呼吸器・甲状腺外科(東京都)
国際医療福祉大学三田病院 呼吸器センター(東京都)


Other administrative information

Date of disclosure of the study information

2015 Year 02 Month 16 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

Enrolling by invitation

Date of protocol fixation

2014 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 12 Month 01 Day

Last follow-up date

2018 Year 05 Month 01 Day

Date of closure to data entry

2019 Year 05 Month 01 Day

Date trial data considered complete

2019 Year 05 Month 01 Day

Date analysis concluded

2019 Year 05 Month 01 Day


Other

Other related information



Management information

Registered date

2015 Year 02 Month 16 Day

Last modified on

2016 Year 08 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019209


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name