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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000017069
Receipt No. 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

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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
Institute North East Japan Study Group (NEJSG)
Institute
Department

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
URL(English) 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


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