UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029476 |
|---|---|
| Receipt number | 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 | 2023/10/14 10:43:11 |
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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
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
hgyoshioka@gmail.com
Sponsor or person
Institute
North East Japan Study Group (NEJSG)
Institute
Department
Personal name
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
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
16
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
| 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
| 2022 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 10 | Month | 31 | Day |
Other
Other related information
On February 25, 2019, the project was transferred to specific clinical research under the Clinical Research Act.
Management information
Registered date
| 2017 | Year | 10 | Month | 09 | Day |
Last modified on
| 2023 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033413
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