UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017069
Receipt number R000019773
Scientific Title Randomized phase III study comparing erlotinib plus bevacizumab to erlotinib alone in patients with previously untreated non-small cell lung cancer harboring EGFR mutation (NEJ026)
Date of disclosure of the study information 2015/04/07
Last modified on 2018/08/09 21:04:36

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Basic information

Public title

Randomized phase III study comparing erlotinib plus bevacizumab to erlotinib alone in patients with previously untreated non-small cell lung cancer harboring EGFR mutation (NEJ026)

Acronym

Randomized phase III study of erlotinib + bevacizumab vs erlotinib (NEJ026)

Scientific Title

Randomized phase III study comparing erlotinib plus bevacizumab to erlotinib alone in patients with previously untreated non-small cell lung cancer harboring EGFR mutation (NEJ026)

Scientific Title:Acronym

Randomized phase III study of erlotinib + bevacizumab vs erlotinib (NEJ026)

Region

Japan


Condition

Condition

Advanced non-squamous non-small cell lung cancer

Classification by specialty

Pneumology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

to investigate the efficacy and the safety of erlotinib plus bevacizumab in comparison with erlotinib alone

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III


Assessment

Primary outcomes

Progression-free survival

Key secondary outcomes

Overall survival, response rate, disease control rate, duration of response, safety, QOL


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

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 + Bevacizumab

Interventions/Control_2

Erlotinib

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 documented non-squamous NSCLC
(2)EGFR (Exon 19 deletion or Exon 21 L858R) mutation status, detected with PCR, is active
(3)Stage IIIB or stage IV or recurrent NSCLC
(4)No prior systemic chemotherapy. Patients with history of treatment with anticancer drugs for pleurodesis are not eligible. If patients have received neoadjuvant / adjuvant chemotherapy, the patients who experience recurrence after 6 months are permitted
(5)Regarding the patients who have be treated with radiotherapy;
1)Not have received radiotherapy to lesions of lung
2)More than 2 weeks after receiving radiotherapy to lesions except lung
(6)Regarding the patients who have be treated with therapy as follows;
1)More than 4 weeks after the last operation
2)More than 2 weeks after the last pleurodesis except anticancer drugs
3)More than 2 weeks after the last biopsy with an incision
4)More than 2 weeks after the last treatment for injury
5)More than 2 weeks after the last systemic administration of steroid over 4 weeks
6)More than 4 weeks after the last administration of other investigational drugs
(7)Patients who have at least one or more measurable lesion by RESIST (Version1.1)
(8)Aged >=20, at the time of consent
(9)ECOG PS 0-2
(10)Have adequate organ function as follows;
1)neutrophil >=1,500/mm3
2)hemoglobin >=9.0g/dL
3)platelet >=100,000/mm3
4)bilirubin <=1.5mg/dL
5)AST/ALT <=2.5xULN
6)serum creatinine <=1.5mg/dL
7)PaO2(room air) >=70Torr or SpO2 >=94%
8)APTT <=ULN
9)PT-INR <=1.5
10)urine protein under 1+
(11)Written informed consent
(12)Estimated life expectancy at least 3 months

Key exclusion criteria

(1)Exon 20 T790M mutation status, detected with PCR, is active. Have received
(2)Have symptomatic brain metastasis
(3)Have a history of multiple malignancies within 5 years
(4)History of pulmonary hemorrhage or hemoptysis as defined below;
1)Hemosputum continuing for more than 1 week within 1 year before enrollment.
2)Have had or require continuous oral administration of hemostat
3)Have had or require injectable administration of hemostat
(5)Evidence of bleeding diathesis or hemoptysis
(6)Evidence of tumor invading a perihilar blood vessel or cavitation in intra-thoracic lesion on imaging
(7)Evidence of tumor invading segmental bronchus
(8)Uncontrolled pleural, ascites effusion or cardiac effusion
(9)Having a history or serious complications as bellows;
1)SVC syndrome complication
2)Spinal cord compression
3)Having a history of serious symptomatic cerebrovascular disease within 1 year before enrollment
4)Unrecovered fracture or severe injury
5)Have severe infection
6)Having a history or evidence of ILD complication on imaging or lung infection (except history of radiation pneumonitis in radiation area)
7)Have gastrointestinal dysfunction as follows;
<1>Impossible to take drugs orally
<2>Need intravenous feeding
<3>Have malabsorption by surgery
<4>Have active peptic ulcer
8)Have severe corneal disease complication
9)Have severe heart disease complication
10)Have diverticulitis
11)Have ever had a history of gastrointestinal perforation within 1 year prior to registration
12)Have severe neurological deficit or mental disorder
13)Have active hepatic disease
(10)Surgery planned in trial period
(11)Have a history of severe allergy of other monoclonal antibody drugs
(12)Have a history of EGFR TKI or anti-angiogenesis drug administration
(13)Pregnant or breast-feeding woman
(14)Patients who have no will to contraception
(15)Patients whose participation in the trial is judged to be inappropriate by the doctor

Target sample size

214


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Makoto Maemondo

Organization

Iwate Medical University

Division name

Division of pulmonary medicine, allergy, and rheumatology

Zip code


Address

19-1 Uchimaru Morioka

TEL

019-651-5111

Email

maemondo-ma693@aioros.ocn.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tatsuro Fukuhara

Organization

Miyagi Cancer Center

Division name

Department of Respiratory Medicine

Zip code


Address

47-1 Nodayama, Medeshima-Shiode, Natori 981-1293

TEL

022-384-3151

Homepage URL


Email

mcc-konai@miyagi-pho.jp


Sponsor or person

Institute

North East Japan Study Group (NEJSG)

Institute

Department

Personal name



Funding Source

Organization

CHUGAI PHARMACUTICAL CO., LTD.

Organization

Division

Category of Funding Organization

Profit organization

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

宮城県立がんセンター(宮城県)


Other administrative information

Date of disclosure of the study information

2015 Year 04 Month 07 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

No longer recruiting

Date of protocol fixation

2015 Year 03 Month 18 Day

Date of IRB


Anticipated trial start date

2015 Year 04 Month 20 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

2015 Year 04 Month 07 Day

Last modified on

2018 Year 08 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019773


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name