UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012215
Receipt number R000014283
Scientific Title A phase II study of Cisplatin+Pemetrexed +Bevacizumab for gefitinib refractory NSCLC patients with mutated EGFR
Date of disclosure of the study information 2013/11/05
Last modified on 2023/05/22 11:43:26

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Basic information

Public title

A phase II study of Cisplatin+Pemetrexed
+Bevacizumab for gefitinib refractory NSCLC patients with mutated EGFR

Acronym

A phase II study of Cisplatin+Pemetrexed
+Bevacizumab for gefitinib refractory NSCLC patients with mutated EGFR

Scientific Title

A phase II study of Cisplatin+Pemetrexed
+Bevacizumab for gefitinib refractory NSCLC patients with mutated EGFR

Scientific Title:Acronym

A phase II study of Cisplatin+Pemetrexed
+Bevacizumab for gefitinib refractory NSCLC patients with mutated EGFR

Region

Japan


Condition

Condition

Non-small cell lung cancer(Non squamous)

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the he response rate and feasibility of Carboplatin+Pemetrexed+Bevacizumab in patients with Gefitinib refractory non-squamous Non-small cell lung cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Response rate

Key secondary outcomes

PFS,OS,Beyond PD lesion Response Rate: BPRR


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

Cisplatin+Pemetrexed+Bevacizumab every 3 weeks. Responding patients receive Pemetrexed+Bevacizumab maintenance.EGFR-TKI continue until PD.

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 confirmed non-squamous NSCLC with activating EGFR-mutations
2. no previous chemotherapy
3. Stage IIIB, VI
4. measurable disease
5. 75>age >=20 years
6. performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale
7. adequate organ function
adequate bone marrow (neutrophil count > =1,500/mm3, hemoglobin concentration > =9.0g/dL, platelet count >= 100,000 /mL), kidney (creatinine>= Cr 60), liver (aspartate aminotransferase [AST] and alanine aminotransferase [ALT] < =institutional normal level x 2.5, total bilirubin< =institutional normal level x 1.5 ), SpO2> =90%, Proteinuria< 1+
8. PD after EGFR-TKI treatment more than 6 month

Key exclusion criteria

1. Medication with anti-coagulative
2.Active infection or other serious conditions
3. Severe pleural effusion or uncontrollable pleural effusion
4.Symptomatic brain metastasis
5. Uncontrollable hypertension
6. Uncontrollable diabetes mellitus
7. Current or previous history of hemoptysis or hemosputum
8. Current or previous (within the last 1 year) history of GI perforation
9. Interstitial pneumonia or pulmonary fibrosis detectable on CT scan
10.Tumor invasive to the chest large blood vessel.
11.Evidence of bleeding diathesis or coagulopathy
12.History of active double cancer
13.History of active psychological disease
14.History of pregnancy or lactation
15. Active concomitant malignancy
16. Active mental illness
17. Previous treatment with Carboplatin or Pemetrexed or Bevacizumab
18. History of severe heart disease(uncontrollable arrythmia,uncontrollable angina pectoris etc)

Target sample size

28


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hirohisa Yoshizawa

Organization

Niigata University Medical and Dental Hospital

Division name

Bioscience Medical Research Center

Zip code


Address

1-754 Asahimachi-Dori,Niigata City, Niigata 951-8520

TEL

025-227-2517

Email

hy0522@med.niigata-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hirohisa Yoshizawa

Organization

Niigata University Medical and Dental Hospital

Division name

Bioscience Medical Research Center

Zip code


Address

1-754 Asahimachi-Dori,Niigata City, Niigata 951-8520

TEL

025-227-2517

Homepage URL


Email

hy0522@med.niigata-u.ac.jp


Sponsor or person

Institute

Niigata Lung Cancer Treatment Group

Institute

Department

Personal name



Funding Source

Organization

Niigata Foundation for the Promotion of Medicine

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan


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

燕労災病院(新潟県)
厚生連長岡中央綜合病院(新潟県)
国立病院機構西新潟中央病院(新潟県)
済生会新潟第二病院(新潟県)
上越総合病院(新潟県)
新潟県立がんセンター(新潟県)
新潟県立吉田病院(新潟県)
新潟県立新発田病院(新潟県)
新潟県立中央病院(新潟県)
新潟市民病院(新潟県)
新潟大学医歯学総合病院(新潟県)
新潟労災病院(新潟県)
長岡赤十字病院(新潟県)


Other administrative information

Date of disclosure of the study information

2013 Year 11 Month 05 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

2013 Year 03 Month 11 Day

Date of IRB

2013 Year 03 Month 27 Day

Anticipated trial start date

2013 Year 04 Month 01 Day

Last follow-up date

2015 Year 04 Month 01 Day

Date of closure to data entry

2015 Year 06 Month 01 Day

Date trial data considered complete

2015 Year 07 Month 01 Day

Date analysis concluded

2015 Year 09 Month 01 Day


Other

Other related information



Management information

Registered date

2013 Year 11 Month 05 Day

Last modified on

2023 Year 05 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014283


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name