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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000003737
Receipt No. R000004512
Scientific Title Phase 2 study of Pemetrexed + Carboplatin + Bevacizumab as first line therapy for nonsquamous non-small cell lung cancer with EGFR Mutation (CJLSG0910)
Date of disclosure of the study information 2010/06/11
Last modified on 2019/03/31

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Basic information
Public title Phase 2 study of Pemetrexed + Carboplatin + Bevacizumab as first line therapy for nonsquamous non-small cell lung cancer with EGFR Mutation (CJLSG0910)
Acronym Pemetrexed + Carboplatin + Bevacizumab as first line therapy for nonsquamous non-small cell lung cancer with EGFR Mutation
Scientific Title Phase 2 study of Pemetrexed + Carboplatin + Bevacizumab as first line therapy for nonsquamous non-small cell lung cancer with EGFR Mutation (CJLSG0910)
Scientific Title:Acronym Pemetrexed + Carboplatin + Bevacizumab as first line therapy for nonsquamous non-small cell lung cancer with EGFR Mutation
Region
Japan

Condition
Condition Advanced non-squamous non-small cell lung cancer with EGFR Mutation
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of combination therapy with pemetrexed, carboplatin and bevacizumab for non-squamous non small cell lung cancer patients with epidermal growth factor receptor mutation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Response rate
Key secondary outcomes Safety
Disease control rate
Overall survival
Progression free survival

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients receive Pemetrexed 500mg/m2 day1 + Carboplatin AUC6 day1 + Bevacizumab 15mg/kg day1, q3w, 4-6 cycles.
Patients who achieved disease control receive Pemetrexed 500mg/m2 day1 + Bevacizumab 15mg/kg day1, q3w until disease progression.
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 proven non-squamous non small cell lung cancer
2) Patients with EGFR mutation (exon 19 deletion or L858R)
3) Patients with stage IIIB or IV, or recurrent disease after surgery and was not a candidate for curative radiotherapy
4) No prior chemotherapy
5) Patient who has measurable lesion by RECIST
6) Age: 20-74
7) ECOG PS: 0-1
8) Adequate organ function
9) Life expectancy more than 3 months
10) Written informed consent
Key exclusion criteria 1) Brain metastasis
2) Hemoptysis (>=2.5ml)
3) Active infection
4) Fever
5) Serious disease condition
6) Active double cancer
7) Cavity fluid retention difficult to control
8) Severe drug allergy
9) Receiving anticoagulant drug (except Aspirin under 325mg/day)
10) Active GI bleeding or inflammation in the abdominal cavity.
11) Pregnancy or lactation
12) Patients whose participation in the trial is judged to be inappropriate by the attending doctor
Target sample size 32

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Taniguchi
Organization Tosei General Hospital
Division name Respiratory medicine and allergy
Zip code
Address 160 Nishi-oiwake-cho, Seto, Aichi, Japan
TEL 0561-82-5101
Email lung@tosei.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoki Kimura
Organization Tosei General Hospital
Division name Respiratory medicine and allergy
Zip code
Address 160 Nishi-oiwake-cho, Seto, Aichi, Japan
TEL 0561-82-5101
Homepage URL
Email lung@tosei.or.jp

Sponsor
Institute Central Japan Lung Study Group
Institute
Department

Funding Source
Organization Central Japan Lung Study Group
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
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

Other administrative information
Date of disclosure of the study information
2010 Year 06 Month 11 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 Main results already published
Date of protocol fixation
2010 Year 05 Month 06 Day
Date of IRB
2010 Year 06 Month 01 Day
Anticipated trial start date
2010 Year 06 Month 01 Day
Last follow-up date
2016 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 06 Month 11 Day
Last modified on
2019 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004512

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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