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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029476
Receipt No. R000033413
Scientific Title Phase II study of combination chemotherapy of Carboplatin, Pemetrexed, Bevacizumab and Erlotinib in patients with advanced non-squamous non-small cell lung cancer harboring EGFR active mutation.
Date of disclosure of the study information 2017/10/30
Last modified on 2019/03/22

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Basic information
Public title Phase II study of combination chemotherapy of Carboplatin, Pemetrexed, Bevacizumab and Erlotinib in patients with advanced non-squamous non-small cell lung cancer harboring EGFR active mutation.
Acronym Phase II study of 4-drug combination chemotherapy in patients with non-small cell lung cancer harboring EGFR active mutation.
Scientific Title Phase II study of combination chemotherapy of Carboplatin, Pemetrexed, Bevacizumab and Erlotinib in patients with advanced non-squamous non-small cell lung cancer harboring EGFR active mutation.
Scientific Title:Acronym Phase II study of 4-drug combination chemotherapy in patients with non-small cell lung cancer harboring EGFR active mutation.
Region
Japan

Condition
Condition non-squamous non-small cell lung cancer harboring EGFR active mutation
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy and tolerability of combination chemotherapy using carboplatin and pemetrexed as cytotoxic agents, and bevacizumab as an anti-angiogenic agent in combination with erlotinib as one of standard therapies for non-squamous non-small cell lung cancer with active EGFR mutation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Progression-free survival
Key secondary outcomes Overall Response Rate (ORR)
Disease Control Rate (DCR)
Overall Survival (OS)
Safety profiles

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Four-drug combination chemotherapy of carboplatin, pemetrexed, bevacizumab and erlotinib
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-squamous non-small cell lung cancer
2, Stage IIIB, IIIC, IVA and IVB without indication of curative therapy or postoperative recurrent condition (UICC 8th)
3, EGFR active mutation i.e. exon 19 deletion or exon 21 L858R point mutation (a patient with complex mutations is excluded except for the combination of exon 19 deletion and exon 21 L858R point mutation)
4, One or more mesurable lesion(s)
5, chemotherapy-naive patient (Any preoperative or postoperative chemotherapy given at least 6 months before enrollment in the present study is eligible)
6, Aged 20 or older at the time of informed consent
7, Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1
8, Adequate oral intake
9, Adequate organ function
10, All of the following criteria are met based on the latest data obtained within 14 days before enrollment:
1) Neutrophil count >= 1,500/mm^3
2) Hemoglobin >= 9.0 g/dL
3) Platelet count >= 10*10^4/mm^3
4) Total bilirubin <= 1.5 mg/dL (<= 2.0 mg/dl in case liver metastases is present)
5) AST(GOT) <= 2.5 X ULN and ALT(GPT) <= 2.5 X ULN (<= 5.0 X ULN if liver metastases is present)
6) Creatinine <= 1.5 X ULN
7) SpO2 >= 95% in room air or PaO2 is 80 torr or more.
8) Urinary protein is 1+ or less.
11, At the time of registration, the following period should elapse since the end of the following prior treatment:
Palliative radiation therapy: 2 weeks or more.
Surgical therapy (including examination or exploratory thoracotomy): 4 weeks or more.
Thoracic / cardiac drainage therapy: 2 weeks or more.
12, Estimated life expectancy should be more than 90 days from the date of registration.
13, Have given written consent to participate in the study after receiving detailed explanation of the study.
Key exclusion criteria 1, Evident pulmonary fibrosis or interstitial lung disease on chest X-ray
2, History of radiotherapy for primary lesion (Eligible if primary lesion is out of radiation field)
3, Presence or past history of hemoptysis (>= 2.5 ml)
4, Predisposing factor of airway bleeding i.e. disorder of coagulation, tumor invasion to major vessels, evident cavitary lesions, and tumor invasion of bronchus mucosa
5, Symptomatic central nervous system metastases
6, Active infectious disease (excluding viral hepatitis)
7, Severe complication (congestive heart failure, chronic renal failure, chronic liver failure, bleeding peptic ulcer, paralysis of intestine, ileus, uncontrollable diabetes mellitus, and so on)
8, Ascites or pleural effusion requiring drainage
9, Active double cancer
10, Elective surgery after enrollment of the study
11, Pregnant or lactating females, females of child-bearing potential, and males desiring partner's pregnancy
12, Severe mental disorder
13, Severe drug hypersensitivity
14, Active hepatic disease
15, Any other condition unsuitable for enrolling the study judged by the attending doctor
Target sample size 35

Research contact person
Name of lead principal investigator
1st name Takayasu
Middle name
Last name Kurata
Organization Kansai Medical University Hospital
Division name Department of Thoracic Oncology
Zip code 573-1191
Address 2-3-1 Shin-machi, Hirakata, 573-1191, Osaka, Japan
TEL 072-804-0101
Email kuratat@hirakata.kmu.ac.jp

Public contact
Name of contact person
1st name Hiroshige
Middle name
Last name Yoshioka
Organization Kansai Medical University Hospital
Division name Department of Thoracic Oncology
Zip code 573-1191
Address 2-3-1 Shin-machi, Hirakata, 573-1191, Osaka, Japan
TEL 072-804-0101
Homepage URL
Email hgyoshioka@gmail.com

Sponsor
Institute North East Japan Study Group (NEJSG)
Institute
Department

Funding Source
Organization North East Japan Study Group (NEJSG)
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kansai Medical University Hospital
Address 2-3-1 Shin-machi, Hirakata, 573-1191, Osaka, Japan
Tel 072-804-0101
Email yoshihir@hirakata.kmu.ac.jp

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 関西医科大学附属病院、国立病院機構旭川医療センター、JCHO北海道病院、北海道大学病院、国立病院機構北海道医療センター、坂総合病院、宮城県立がんセンター、大曲厚生医療センター、一般財団法人慈山会医学研究所付属坪井病院、国立病院機構茨城東病院、佐野厚生総合病院、埼玉医科大学国際医療センター、埼玉医科大学病院、自治医科大学附属さいたま医療センター、総合病院国保旭中央病院、順天堂大学医学部附属練馬病院、江戸川病院、広島大学病院、県立広島病院、久留米大学病院などのNorth East Japan Study Group参加施設

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 30 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
2017 Year 09 Month 07 Day
Date of IRB
2017 Year 10 Month 20 Day
Anticipated trial start date
2017 Year 11 Month 01 Day
Last follow-up date
2019 Year 02 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 10 Month 09 Day
Last modified on
2019 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033413

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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