UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013354 |
|---|---|
| Receipt number | R000015582 |
| Scientific Title | Randomized phase II study of carboplatin + paclitaxel + bevacizumab or cisplatin + pemetrexed + bevacizumab in patients with previously untreated locally advanced or metastatic non-squamous non-small cell lung cancer (CLEAR study) |
| Date of disclosure of the study information | 2014/03/06 |
| Last modified on | 2021/08/17 10:10:45 |
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Basic information
Public title
Randomized phase II study of carboplatin + paclitaxel + bevacizumab or cisplatin + pemetrexed + bevacizumab in patients with previously untreated locally advanced or metastatic non-squamous non-small cell lung cancer (CLEAR study)
Acronym
Randomized phase II study of CBDCA + PTX + BEV or CDDP + PEM + BEV in patients with previously untreated locally advanced or metastatic non-sq NSCLC (CLEAR study)
Scientific Title
Randomized phase II study of carboplatin + paclitaxel + bevacizumab or cisplatin + pemetrexed + bevacizumab in patients with previously untreated locally advanced or metastatic non-squamous non-small cell lung cancer (CLEAR study)
Scientific Title:Acronym
Randomized phase II study of CBDCA + PTX + BEV or CDDP + PEM + BEV in patients with previously untreated locally advanced or metastatic non-sq NSCLC (CLEAR study)
Region
| Japan |
Condition
Condition
Advanced non-squamous non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and the safety of double maintenance regimen (CDDP+PEM+BEV) by comparing with standard regimen (CBDCA+PTX+BEV) in patients with advanced non-sq NSCLC
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Progression-free survival (central review)
Key secondary outcomes
Overall survival, response rate, disease control rate, duration of response, time to treatment failure, toxicity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Combination chemotherapy of carboplatin + paclitaxel + bevacizumab
Interventions/Control_2
Combination chemotherapy of cisplatin + pemetrexed + bevacizumab
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
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Histologically or cytologically proven non-squamous NSCLC (Mixed type is classified into dominant histology but mixed small cell histology is not permitted.)
(2) Clinical stage IIIB or stage IV or recurrent non-squamous NSCLC for which they had not received any prior systemic chemotherapy, not candidate for curative radiotherapy (If patients have received adjuvant chemotherapy, the patients who experience recurrence after 48 weeks and have not received 1st line therapy are permitted.)
(3) EGFR (Exon 19 deletion or Exon 21 L858R) mutation status is not active and ALK fusion gene is negative or unknown
(4) ECOG Performance Status (PS) 0-1
(5) Patients who have at least one or more measurable lesion by RECIST(Version1.1)
(6) Aged 20-74 at the time of consent
(7) Adequate organ function
(8) Interval
1) Radiation therapy
More than 2 weeks after the last radiation therapy for nonthoracic region or brainmetastasis
2) Operation
More than 4 weeks after the last operation
More than 2 weeks after the last pleurodesis or thoracic drainage
More than 4 weeks after the last operation with brain metastasis
(9) Estimated life expectancy at least 12 weeks
(10) Written informed consent
Key exclusion criteria
(1) Having treatment history of pemetrexed or paclitaxel or bevacizumab
(2) History of pulmonary hemorrhage/hemoptysis defined as bright red blood of at least 2.5mL within 3 months prior to registration
(3) Radiotherapy to lung field or mediastinum
(4) Evidence of tumor invading a perihilar blood vessel, heart and major blood vessel on imaging
(5) Evidence of tumor invading segmental bronchus
(6) Evidence of cavitation in intra-thoracic lesion
(7) Severe infection
(8) Fever (over 38 degrees)
(9) Having serious complications
(10) Uncontrolled ascites, pleural effusion or cardiac effushion
(11) Active concomitant malignancies
(12) History of multiple malignancies within 5 years
(13) Severe drug allergy
(14) Active gastrointenstinal ulcer
(15) History of gastrointestinal perforation within 1 year prior to registration
(16) History of diverticulitis or fistula
(17) Active hepatic disease
(18) Embolic complications or having past history of arterial thrombosis or severe venous thrombosis within 1 year
(19) Uncontrollable hypertention
(20) Current or recent (within 10 days prior to first dose of bevacizumab) use of aspirin (> 325mg/day), clopidogrel (> 75mg/day), or anticlotting drug or thrombolytic agent
(21) Symptomatic brain metastasis
(22) Pregnant women
(23) Patients whose participation in the trial is judged to be inappropriate by the doctor
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Goto |
Organization
National Cancer Center Hospital East
Division name
Department of Thoracic Oncology
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577
TEL
04-7133-1111
kgoto@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Hibiki |
| Middle name | |
| Last name | Udagawa |
Organization
National Cancer Center Hospital East
Division name
Division of Thoracic Oncology
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577
TEL
04-7133-1111
Homepage URL
hudagawa@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
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
MINS
Address
5-20-9-401 Mita, Minatoku
Tel
03-6416-1868
npo-mins@j-irb.com
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
独立行政法人地域医療機能推進機構 北海道病院
学校法人岩手医科大学岩手医科大学附属病院
一般財団法人厚生会仙台厚生病院
地方独立行政法人宮城県立病院機構宮城県立がんセンター
独立行政法人国立病院機構弘前病院
公立大学法人福島県立医科大学附属病院
千葉県がんセンター
独立行政法人国立国際医療研究センター病院
学校法人順天堂順天堂大学医学部附属順天堂医院
公益財団法人結核予防会複十字病院
独立行政法人国立病院機構東京病院
地方独立行政法人神奈川県立病院機構循環器呼吸器病センター
横浜市立市民病院
学校法人北里研究所北里大学病院
大垣市民病院
社会福祉法人京都社会事業財団京都桂病院
独立行政法人国立病院機構金沢医療センター
国立大学法人福井大学医学部附属病院
独立行政法人国立病院機構近畿中央胸部疾患センター
日本赤十字社神戸赤十字病院
国家公務員共済組合連合会大手前病院
独立行政法人国立病院機構岩国医療センター
独立行政法人国立病院機構山口宇部医療センター
独立行政法人国立病院機構松江医療センター
独立行政法人国立病院機構 福岡東医療センター
独立行政法人国立病院機構 九州医療センター（呼吸器内科）
独立行政法人国立病院機構 九州医療センター（呼吸器外科）
社会医療法人恵佑会札幌病院
旭川医科大学病院
埼玉県立循環器・呼吸器病センター
豊橋市民病院
日本赤十字社名古屋第一赤十字病院
名古屋大学 大学院 医学系研究科
名古屋市立大学 大学院医学研究科
公立陶生病院
一般財団法人大阪府警察協会大阪警察病院
独立行政法人国立病院機構刀根山病院
市立吹田市民病院
松山赤十字病院
学校法人産業医科大学 産業医科大学病院
長崎県島原病院
国立大学法人 鹿児島大学大学院 医歯学総合研究科
独立行政法人国立がん研究センター東病院
兵庫県立がんセンター
学校法人自治医科大学自治医科大学附属病院
国立大学法人大阪大学医学部附属病院
埼玉県立がんセンター
社会医療法人蘇西厚生会 松波総合病院
学校法人昭和大学昭和大学病院
国立大学法人新潟大学医歯学総合病院
国家公務員共済組合連合会虎の門病院
独立行政法人国立病院機構四国がんセンター
ＪＡ北海道厚生連帯広厚生病院
学校法人兵庫医科大学兵庫医科大学病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 06 | Day |
Related information
URL releasing protocol
https://tlcr.amegroups.com/article/view/53333
Publication of results
Published
Result
URL related to results and publications
https://tlcr.amegroups.com/article/view/53333
Number of participants that the trial has enrolled
199
Results
Results: The HR for PFS (CisPemBev/CarPacBev) was 0.825 (95% CI, 0.600-1.134, median PFS, 7.6 vs 7.0 months). Median OS was for CarPacBev (HR 0.845; 95% CI, 0.583-1.242).
Conclusions: CisPem combined with Bev was more effective in improving PFS compared with CarPacBev in patients with advanced nsNSCLC.
Results date posted
| 2021 | Year | 08 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Treatment naive advanced non-squamous NSCLC patients without EGFR mutation and ALK fusion
Participant flow
199 patients were randomly assigned to receive CisPemBev (N=132) or CarPacBev
(N=67)
Adverse events
Both CisPemBev and CarPacBev were well tolerated.
Outcome measures
primary endpoint: PFS
secondary endpoints: OS, ORR, safety and others
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 03 | Month | 04 | Day |
Date of IRB
| 2014 | Year | 12 | Month | 08 | Day |
Anticipated trial start date
| 2014 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 06 | Day |
Last modified on
| 2021 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015582
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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